Key takeaways:
The Pfizer (Comirnaty), Moderna (Spikevax, mNEXSPIKE), and Novavax (Nuvaxovid) COVID-19 vaccines are FDA approved for use in the U.S. The Johnson & Johnson (J&J) vaccine is no longer available as of May 2023.
All four vaccines are approved for adults ages 65 and older, and for younger people with health risks. Comirnaty is approved from age 5, Spikevax from 6 months, and Nuvaxovid and mNEXSPIKE from age 12.
For the 2025-2026 season, the CDC’s vaccine panel has shifted guidance towards individual decision-making. This means the decision to get a COVID vaccine is made between you and a healthcare professional after considering your personal risks and benefits.
The Pfizer, Moderna, and Johnson & Johnson (J&J) vaccines were initially issued emergency use authorizations (EUAs). The EUAs allowed them to be used during the COVID pandemic without being fully FDA approved.
Since then, updated versions of the vaccines have been authorized or approved to address circulating viral variants. Today, there are four options available: Pfizer (Comirnaty), Moderna (Spikevax and mNEXSPIKE), and Novavax (Nuvaxovid).
Here we’ll be tracking the latest on COVID-19 vaccine approvals. Check back with GoodRx for updates.
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CDC vaccine panel votes to recommend individual decision-making for the COVID vaccines
October 1, 2025
CDC shifts away from universal COVID vaccine recommendation
In mid-September, the CDC’s Advisory Committee on Immunization Practices (ACIP) met to vote on this year’s COVID vaccine recommendations. Previously, the ACIP has recommended that everyone ages 6 months and older should get vaccinated for COVID. But for 2025-2026, they’ve voted in favor of individual decision-making.
The CDC director has yet to sign off on this recommendation. But it means that the choice to receive a COVID vaccine should be made between you and a healthcare professional (HCP) after considering your personal risks and benefits. In this case, HCPs are anyone who can provide or administer vaccines, such as physicians, nurses, and pharmacists.
This ACIP vote follows the FDA’s approval of the 2025-2026 COVID vaccines, which include adults 65 and older, and younger people with underlying health risks. But even if you don’t fall into a high-risk group, you can still choose to get a vaccine. Check with your state health department or local pharmacy for their specific requirements.
FDA approves Novavax vaccine and plans for a more targeted approach in the fall
May 22, 2025
FDA approves Novavax vaccine for people ages 65 and older as well as younger age groups at higher risk
In May 2025, the FDA officially approved the Novavax COVID vaccine (Nuvaxovid), which had been authorized for use since 2022. The vaccine is approved for:
Adults ages 65 and older
People ages 12 to 64 at higher risk for severe illness due to health conditions such as asthma, diabetes, or cancer
Who can get a COVID-19 vaccine? Here’s how to navigate the latest recommendations.
Vaccine side effects: Most COVID vaccine side effects are mild and temporary. Here’s what to expect after getting one.
Do you need to wait? If you’ve recently had COVID, find out how long you may need to wait before getting a COVID vaccine.
The manufacturer plans to have an updated 2025-2026 formulation ready for the fall, which will be made to target the virus strains recommended by the FDA. The FDA is scheduled to meet on May 22, 2025 to review and make these recommendations.
FDA plans for a more targeted approach to COVID vaccines in the fall
Along with the Novavax approval, the FDA has said it plans to shift toward a more targeted COVID vaccine strategy for fall 2025. Instead of broad recommendations for the general population, like in years past, the agency will focus its efforts on older adults and individuals with high-risk health conditions.
But for healthy adults under 65, the FDA plans to require randomized, controlled trials showing clear clinical benefits before approving booster shots. This change moves away from approving updated vaccine formulations based on immune response data alone, which will still be used for higher-risk groups. As a result, updated vaccines for healthy, lower-risk people may not be available in time for fall 2025.
FDA authorizes the updated 2024-2025 Novavax vaccine
September 10, 2024
Updated Novavax COVID vaccine now authorized and recommended for use in the U.S.
In late August 2024, the FDA authorized the updated 2024-2025 version of the Novavax COVID vaccine. The vaccine targets the JN.1 strain of the virus, which is slightly different from the updated Pfizer and Moderna vaccines, which target the KP.2 strain.
The CDC recommends that everyone ages 6 months and older receive an updated 2024-2025 COVID vaccine. There’s no preferred option — you can choose between the Pfizer, Moderna, or Novavax vaccine. However, the Novavax vaccine is only authorized for people ages 12 and older.
If you choose to receive Novavax, here’s the recommended schedule:
Never been vaccinated for COVID: You’re eligible to receive 2 updated vaccine doses, given 3 weeks apart.
One prior Novavax dose: You’re eligible to receive 1 updated vaccine dose, at least 3 weeks after your prior dose.
Prior vaccination: If you’ve been vaccinated with a prior COVID vaccine formula (a different COVID vaccine, or at least 2 Novavax doses), you’re eligible to receive 1 updated Novavax dose at least 2 months after your last vaccine dose.
FDA and CDC sign off on updated 2024-2025 Pfizer and Moderna vaccines
August 23, 2024
Updated Pfizer and Moderna vaccines are approved or authorized for certain age groups
This week, the FDA approved and authorized updated versions of the Pfizer and Moderna COVID vaccines (2024-2025 formula). These two vaccines both target the Omicron variant KP.2 strain of the virus. The FDA announcement follows the CDC’s statement last month recommending the updated vaccines. These vaccines are expected to be available in the coming days.
Everyone ages 6 months and older is recommended to receive an updated COVID vaccine. The doses and timing can depend on your age and vaccine history.
People ages 5 and older (any vaccination status): single updated vaccine dose, at least 2 months after the last dose of any COVID vaccine
Children ages 6 months through 4 years (previously vaccinated): one or two updated vaccine doses, depending on prior COVID vaccines received
Children ages 6 months through 4 years (no prior vaccination): three updated vaccine doses (Pfizer) or two updated vaccines doses (Moderna)
Additionally, children ages 6 months through 11 years old who are immunocompromised may be advised to receive additional vaccine doses. Talk to your healthcare team about vaccine eligibility and timing.
The updated Novavax COVID vaccine, which targets the JN.1 strain, wasn’t included in the FDA’s announcement. It will likely be authorized for use at a later date.
CDC recommends additional updated COVID vaccine dose for older adults
March 1, 2024
People ages 65 and older are now eligible for an additional vaccine dose to provide added protection
This week, the CDC announced that it recommends an additional updated 2023-2024 COVID vaccine dose for older adults ages 65 and older. The announcement follows an expert panel vote in favor of recommending an additional dose for this age group.
If you're 65 or older, you’re eligible for an additional vaccine dose if it has been at least 4 months since your previous vaccine dose. And if you’ve recently had COVID, you may consider delaying your additional dose for 3 months after your infection. Speak with your healthcare team if you have any questions about specific vaccine recommendations and timing.
FDA authorizes updated Novavax COVID vaccine
October 9, 2023
Updated Novavax vaccine is now an option for people ages 12 and older
Last week, the FDA authorized the updated Novavax vaccine for people ages 12 and older. Similar to the updated Pfizer and Moderna vaccines, it specifically targets the XBB.1.5 subvariant. The vaccine was also part of the CDC’s initial recommendations regarding updated COVID vaccines, pending its authorization.
People who last received any COVID vaccine at least 2 months ago (with the exception of the updated Pfizer or Moderna vaccines) are eligible for 1 updated Novavax dose. People who’ve never received a COVID vaccine can receive 2 doses, 3 weeks apart.
FDA and CDC sign off on updated Pfizer and Moderna vaccines for the fall
September 13, 2023
Updated Pfizer and Moderna vaccines are approved or authorized for certain age groups
This week, the FDA signed off on updated versions of the Pfizer and Moderna COVID vaccines. The updated vaccines are designed to target the XBB.1.5 subvariant.
For people ages 12 and older, both vaccines are approved for a single dose, regardless of vaccination status. If you previously receive any COVID vaccine, you’re eligible for the updated vaccine if it has been at least 2 months since your last dose.
For children ages 5 to 11 years old, both vaccines are authorized for a single dose, regardless of vaccination status. The timing is the same as above — at least 2 months after your last dose. They’re also authorized for children ages 6 months to 4 years old. But the number of doses and timing for these younger kids depends on their vaccination history.
Following the FDA announcement, a CDC expert panel voted in favor of recommending the updated Pfizer and Moderna vaccines. The CDC has since officially recommended the vaccines for everyone ages 6 months and older.
Note: The updated Novavax vaccine is still under FDA review.
FDA and CDC update COVID-19 vaccine recommendations for initial series and boosters
May 2, 2023
Original Pfizer and Moderna COVID-19 vaccines no longer authorized in the U.S.
On April 18, 2023, the FDA announced that the original Pfizer and Moderna COVID-19 vaccines are no longer authorized for use in the U.S. Instead, the bivalent (updated) version of the vaccines will be used for all vaccine doses. This includes initial, additional, and booster shots. A similar CDC announcement was released the next day.
What’s more, instead of receiving multiple vaccine doses as part of the primary vaccine series, certain unvaccinated people may be able to receive one updated vaccine dose. This recommendation may be different for certain unvaccinated children ages 5 and under.
For children, updated vaccine eligibility criteria can depend on their age and which vaccine they’ve received previously. Check with your child’s pediatrician about which vaccines they can receive and when.
Certain people may qualify for a second updated booster shot
In the same announcements, the FDA and CDC cleared certain groups to receive a second updated booster shot. This includes adults ages 65 and older who got an initial updated booster at least 4 months ago, and immunocompromised people who got an initial updated booster at least 2 months ago. Additional doses may be given to immunocompromised people as needed.
Immunocompromised children, aged 6 months through 4 years old, may be eligible for a second updated booster, depending on their last vaccine dose.
If you think you might qualify for an updated booster shot, speak with your healthcare provider.
FDA and CDC sign off on updated COVID-19 vaccines in children under 5 years old
December 13, 2022
Children under 5 years old who received the Moderna primary vaccine series eligible for updated Moderna booster shot
Late last week, the FDA and CDC signed off on the updated Moderna COVID-19 vaccine for children ages 6 months through 4 years old who received the Moderna vaccine for their primary vaccine series.
This group is now eligible for an updated Moderna booster if it has been at least 2 months since completing their primary vaccine series.
Children under 5 years old eligible to receive updated Pfizer vaccine as third dose in primary vaccine series
In addition to the Moderna announcement, the updated Pfizer vaccine is also authorized in children under 5 years old.
Children ages 6 months through 4 years old are now eligible to receive the updated Pfizer vaccine as the third dose in their primary Pfizer vaccine series. As of right now, this group isn’t eligible to receive an updated booster shot. But this could change in early 2023.
Pfizer requests EUA for updated COVID-19 vaccine in children under 5 years old
December 5, 2022
Updated Pfizer vaccine could be authorized as third primary series dose for young children
This week, Pfizer submitted an EUA request for its updated COVID-19 vaccine to be used as the third primary series dose in children ages 6 months through 4 years old. The updated vaccine targets the original version of the virus that causes COVID-19, plus the BA.4/BA.5 subvariants.
Currently, children in this age group receive three vaccine doses as part of their primary vaccine series. The EUA is requesting that the first two doses remain the original vaccine. The third dose would be the updated vaccine.
As of right now, there hasn’t been a timeline announced for when the FDA may make its decision.
FDA and CDC sign off on mRNA boosters for young children and Novavax boosters in adults
October 20, 2022
Novavax COVID-19 vaccine now authorized as initial booster in adults ages 18 and older
This week, the FDA and CDC signed off on the Novavax COVID-19 vaccine to be given as an initial booster shot in adults ages 18 and older. Unlike the updated Pfizer and Moderna boosters, the Novavax booster is the same vaccine that’s given for your primary series. It’s a monovalent vaccine that targets the original strain of the virus.
You’re eligible to receive a Novavax booster if it has been at least 6 months since completing your primary vaccine series. It doesn’t matter which COVID-19 vaccine you received initially. It’s also reserved for people who can’t or don’t want to receive the updated Pfizer or Moderna boosters.
People ages 5 and older now eligible for updated boosters
The FDA and CDC have also signed off on updated boosters for younger age groups. The latest recommendation allows for updated Pfizer boosters to be given to people ages 5 and older, and for updated Moderna boosters to be given to people ages 6 and older.
These groups are eligible for updated boosters if it has been at least 2 months since completing the primary vaccine series or their last booster shot.
FDA and CDC sign off on bivalent COVID-19 vaccine booster shots
September 6, 2022
Updated Pfizer and Moderna COVID-19 booster shots are rolling out across the U.S.
Late last week, both the FDA and CDC signed off on the Pfizer and Moderna bivalent booster shots for those who are eligible. The shots contain instructions for the spike protein from both the original virus and Omicron BA.4 and BA.5 subvariants.
People ages 12 and older can receive the Pfizer bivalent booster if it has been at least 2 months since their last vaccine dose (primary vaccine series or booster). The same timeline applies to the Moderna booster, but only adults ages 18 and older can receive it.
Several pharmacy chains, including CVS and Walgreens, have announced that bivalent booster shot appointments are now available.
Updated COVID-19 booster shots could be available around Labor Day
August 29, 2022
FDA planning to authorize updated Pfizer and Moderna booster shots around Labor Day
In late June, an FDA expert panel voted to recommend COVID-19 booster shots that included Omicron variants for fall and winter 2022. The shots would contain instructions for the spike protein from both the original virus and the Omicron BA.4/5 subvariants (called a bivalent booster).
Last week, both Pfizer and Moderna announced completed FDA submissions for their respective bivalent boosters. Pfizer is requesting booster authorization in people ages 12 and older, and Moderna is requesting authorization for adults only.
It has been reported that the FDA plans to authorize the Pfizer and Moderna bivalent booster shots around Labor Day. The CDC could also sign off on the boosters soon after a CDC expert panel meets on September 1st and 2nd.
The U.S. government has secured 66 million Moderna and 105 million Pfizer bivalent booster doses for the fall and winter.
FDA authorizes Novavax COVID-19 vaccine for adolescents ages 12 to 17 years old
August 22, 2022
FDA expands Novavax COVID-19 vaccine emergency use to include people ages 12 and older
Last week, the FDA authorized the Novavax COVID-19 vaccine for emergency use in adolescents ages 12 to 17 years old. The CDC has also recommended the vaccine for this age group. It was previously only authorized for adults ages 18 and older.
Now, adolescents have a third vaccination option against COVID-19, in addition to the Pfizer and Moderna vaccines. They can receive the Novavax COVID-19 vaccine for their two-dose primary series, with doses given 3 weeks apart. Adolescents receive the same dosage as adults.
FDA authorizes Novavax COVID-19 vaccine for emergency use in adults
July 14, 2022
Novavax vaccine becomes fourth COVID-19 vaccine authorized for use in the U.S.
This week, the FDA authorized the Novavax COVID-19 vaccine for emergency use. Now, adults will have a fourth option for vaccination against COVID-19. The vaccine is given as a two-dose primary series administered 3 weeks apart.
The Novavax vaccine works differently compared to the other COVID-19 vaccines available in the U.S. It’s a protein-based, adjuvanted vaccine that uses more conventional vaccine technology. So, it may be a good option for people who’ve been hesitant to receive the Pfizer, Moderna, or J&J vaccines, which use newer technology.
Earlier this week, the Biden administration announced it had secured 3.2 million doses of the Novavax vaccine. But the CDC still needs to weigh in before it’ll be available. A CDC expert panel is scheduled to meet on July 19th, but an agenda hasn’t been released yet.
FDA expands the Pfizer COVID-19 vaccine’s approval to include adolescents ages 12 through 15 years old
July 11, 2022
Pfizer COVID-19 vaccine now fully approved for people ages 12 and older
Late last week, the FDA expanded the Pfizer COVID-19 vaccine’s approval to include adolescents ages 12 through 15 years old.
Prior to this change, the vaccine was approved for people at least 16 years old. And it was authorized for use in children as young as 6 months old. Now, it’s authorized for children ages 6 months through 11 years old, and fully approved for people ages 12 and older.
CDC recommends Moderna COVID-19 vaccine for children and adolescents ages 6 through 17 years old
June 28, 2022
People ages 6 months and older now eligible to receive the Moderna COVID-19 vaccine
Last week, the CDC director recommended the Moderna COVID-19 vaccine for children ages 6 through 17 years old. This follows the CDC’s announcement recommending the vaccine in children ages 6 months through 5 years old. The Moderna vaccine has been authorized for use in adults ages 18 and older since December 2020.
For children and adolescents ages 6 months through 17 years old, the Moderna vaccine is authorized as part of a two-dose primary series. But the amount of mRNA in each dose varies by age as follows:
Ages 6 months through 5 years old: 25 mcg per dose
Ages 6 through 11 years old: 50 mcg per dose
Ages 12 through 17 years old: 100 mcg per dose
CDC recommends COVID-19 vaccine for children ages 6 months through 5 years old
June 20, 2022
People ages 6 months and older now eligible to receive a COVID-19 vaccine
Last week, FDA and CDC expert committees met to review effectiveness and safety data for the Pfizer and Moderna COVID-19 vaccines in young children. Both committees voted in favor of recommending the vaccines, which was followed up with endorsement from the FDA and CDC.
For the Pfizer vaccine, children under 5 years old receive three doses consisting of 3 mcg of mRNA in each dose. For the Moderna vaccine, children under 6 years old receive two doses consisting of 25 mcg of mRNA in each dose.
The FDA has also authorized the Moderna vaccine for use in children ages 6 through 17 years old. However, the CDC committee won’t be meeting until June 23, 2022 to vote on recommending this use.
According to the White House, you may be able to start finding vaccine appointments for your child as early as this week. Availability should ramp up as more doses are shipped out to vaccination sites over the next few days to weeks.
FDA expert panel recommends authorization of Novavax COVID-19 vaccine
June 9, 2022
Novavax COVID-19 vaccine pending FDA decision after expert panel recommendation
Earlier this week, an FDA vaccine expert committee voted to recommend the authorization of Novavax’s COVID-19 vaccine in adults ages 18 and older. The committee voted 21-0 (with one person declining to vote) in favor of the authorization.
The committee reviewed the vaccine’s safety and effectiveness data before making its decision. But it has been reported that the FDA is still reviewing manufacturing details before issuing its decision. After that, the CDC will need to weigh in before the vaccine is available.
Currently, the Novavax vaccine is authorized for adults in more than 40 countries and is listed for emergency use by the World Health Organization (WHO).
CDC recommends Pfizer booster shot for children, ages 5 to 11 years old, and strengthens second booster shot recommendations
May 20, 2022
Pfizer booster recommended for younger children at least 5 months after initial vaccine series
Yesterday, the CDC recommended a single-dose Pfizer booster shot for children ages 5 through 11 years old. Children in this age group would be eligible at least 5 months after their initial shots. The CDC’s decision follows an 11-1 vaccine expert panel vote in favor of the recommendation.
If your child recently had COVID-19, you may be wondering what this means for booster shot timing. In this case, the CDC says that you may consider delaying a booster shot by 3 months from first positive test (if no symptoms) or symptom onset. However, it’s best to talk to your child’s pediatrician about their recommendations and to answer any questions you have about the vaccine.
CDC recommends that people eligible for a second booster shot should receive one
Along with expanding booster shots to younger children, the CDC also strengthened their recommendations around second booster shots. Previously, the recommendation generally stated that certain people were eligible for a second booster shot.
This updated recommendation says that those who are eligible should receive a second booster shot at least 4 months after their initial shots. Eligible groups include adults ages 50 and older, and people ages 12 and older who are immunocompromised.
FDA authorizes Pfizer booster shot for children ages 5 to 11 years old
May 17, 2022
Pfizer vaccine now authorized for children ages 5 to 11; CDC recommendations pending expert panel meeting
Today, the FDA authorized a single booster shot of the Pfizer COVID-19 vaccine in children ages 5 to 11 years old. Children in this age group would be eligible at least 5 months after completing their initial vaccine series. Previously, the vaccine was only authorized for booster shots in people ages 12 and up.
In mid-April, Pfizer reported positive findings from a booster dose trial in children ages 5 through 11 years old. The results showed a 36-fold jump in protective antibody levels against Omicron after the shot. Shortly after this announcement, Pfizer submitted an EUA request to the FDA.
The CDC still needs to weigh in before the booster shot is available and recommended for this age group. Their vaccine expert panel is currently scheduled to meet this Thursday. No agenda is available, but it has been reported that COVID-19 boosters will be discussed.
FDA limits use of the J&J COVID-19 vaccine to certain people
May 6, 2022
J&J vaccine only authorized for people who can’t receive Pfizer or Moderna vaccines, or those only willing to get the J&J vaccine
This week, the FDA limited the authorization of the J&J COVID-19 to certain people. This change was due to the potential risk of rare blood clots that have been linked to the vaccine.
Now, it’s authorized for adults who are unable to receive the Pfizer or Moderna vaccines. It’s also an option if you would otherwise not get vaccinated against COVID-19.
Talk to your healthcare provider if you have questions about which vaccine is right for you. And if you’re unable to get vaccinated due to an allergic reaction, Evusheld (tixagevimab with cilgavimab) may be an option to prevent COVID-19 instead.
FDA announces expert panel meetings to discuss COVID-19 vaccine authorizations
April 29, 2022
Novavax COVID-19 vaccine authorization request to be reviewed in early June
In late January 2022, Novavax announced it had submitted an EUA request to the FDA for its COVID-19 vaccine in adults ages 18 and older. Novavax’s vaccine is a protein-based vaccine that works differently than the COVID-19 vaccines currently authorized and approved in the U.S.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) intends to meet on June 7 to review Novavax’s application. If authorized, it would provide another COVID-19 vaccine option for adults.
Vaccine authorizations for younger children to be reviewed in June
The FDA recently announced three more potential VRBPAC meeting dates in June to review Pfizer and Moderna vaccine data in younger children. Currently, Pfizer’s vaccine is authorized in people ages 5 and older. And only adults ages 18 and up can receive Moderna’s vaccine.
This announcement follows Moderna’s recent request to authorize its vaccine in children under 6 years old. Moderna has also submitted EUA requests for children ages 6 to 12, and adolescents ages 12 to 17.
VRBPAC was previously scheduled to meet in February to review Pfizer’s data in children under 5 years old. But the meeting was postponed until Pfizer could provide third-dose data for this age group. Pfizer expected to have this data in early April.
Pfizer has also recently requested authorization of a booster dose in kids ages 5 to 12. But it’s not clear if that will be discussed during the meeting.
VRBPAC intends to meet June 8, 21, and 22 to review EUA requests for younger children.
VRBPAC to discuss potential COVID-19 vaccine changes for Fall 2022
Given the rise of COVID-19 variants (and subvariants), the VRBPAC is planning to discuss potential changes to the COVID-19 vaccines for Fall 2022. This might include modifying the targeted strains in the vaccines, similar to how flu vaccines are updated based on circulating strains.
VRBPAC intends to hold the meeting on June 28. The meeting would be a follow up to the one held in early April 2022 discussing potential COVID-19 booster strategies.
CDC recommends second booster shot for certain people
April 1, 2022
CDC updates booster recommendations after FDA authorizes second booster shot with a Pfizer or Moderna vaccine
Following the FDA’s announcement earlier this week, the CDC has updated its booster shot recommendations for certain groups. This includes a second booster shot with a Pfizer or Moderna vaccine for adults ages 50 and up and certain people who are immunocompromised. People within these groups are eligible for another shot at least 4 months after their first booster.
People who initially received the J&J vaccine for their primary series and first booster are also eligible for a second booster shot using a Pfizer or Moderna vaccine. Adolescents ages 12 to 17 who are immunocompromised are only eligible to receive the Pfizer vaccine for their booster.
FDA authorizes second mRNA booster for certain people; Moderna plans to request authorization for children under age 6
March 29, 2022
Adults at least 50 years old, and people who are immunocompromised, now eligible to receive second Pfizer or Moderna booster shot
Today, the FDA authorized a second Pfizer or Moderna booster shot at least 4 months after the first booster shot of any authorized COVID-19 vaccine for adults ages 50 and older.
A second mRNA booster shot has also been authorized to be given within the same time frame for certain people who are immunocompromised. This includes people ages 12 and older (Pfizer booster only) and adults ages 18 and older (Pfizer or Moderna booster).
Moderna plans to request emergency authorization for its lower-dose vaccine in children under 6 years old
After announcing positive results last week, Moderna is planning to request emergency authorization in the “coming weeks” for its vaccine in children under 6 years old. If authorized, the vaccine would be the first one available for children under 5 years old. The dose for this age group is 25% of the dose currently given to adults.
Moderna’s COVID-19 vaccine is currently authorized for adults at least 18 years old. The company has already submitted an authorization request for adolescents ages 12 to 17 years old and has started the submission process for children ages 6 to 11 years old.
Sanofi and GSK plan to request authorization for their COVID-19 vaccine
February 24, 2022
The companies plan to submit data for both the two-dose series and booster dose in adults
Yesterday, Sanofi and GSK announced plans to request emergency authorization for their COVID-19 vaccine in adults. The companies plan to submit data for the primary vaccine series and booster shot.
Compared to the mRNA vaccines (Pfizer and Moderna), the Sanofi-GSK COVID-19 vaccine uses more traditional vaccine technology. It’s given as two doses, 21 days apart. Findings show that two doses are 75% effective against moderate or severe COVID-19, and 100% effective against severe disease and hospitalization.
The company also tested antibody levels of a booster dose in people who received other authorized vaccines as their primary series, including the three available in the U.S. (Pfizer, Moderna, and J&J). Results show an 18 to 30-fold jump in antibody levels.
Sanofi and GSK are currently in discussions with the FDA. But no target date has been announced for when they expect to submit their data.
FDA postpones reviewing Pfizer’s request to authorize its COVID-19 vaccine in children under 5 years old
February 14, 2022
FDA plans to wait until 3rd-dose data is available
This week, the FDA’s expert vaccine committee was originally scheduled to meet to review Pfizer’s request to authorize its vaccine in children ages 6 months to 4 years old. But the plans have changed.
After reviewing initial two-dose data provided by Pfizer, the FDA has decided to wait until third-dose data is available for review. That’s because two doses in children ages 2 to 4 years old didn’t cause an adequate immune response. It’s believed that three doses will be required for better protection.
Pfizer expects to have the three-dose data available in early April.
FDA panel to review Pfizer COVID-19 vaccine data in children under 5 years old
February 2, 2022
Pfizer begins EUA process for first two doses of its COVID-19 vaccine in children ages 6 months to 4 years old
Yesterday, Pfizer announced that it has started the EUA submission process for its lower-dose COVID-19 vaccine in children ages 6 months to 4 years old. The company is initially providing the FDA with data from the first two vaccine doses. Each dose contains 3 mcg of mRNA.
But children in this age group are expected to need three doses as part of their primary vaccination series. That’s because the immune response from two doses in children ages 2 to 4 years old wasn’t enough. Pfizer plans to submit third-dose data in the coming months.
Expert vaccine committee scheduled to review Pfizer data mid-February
The FDA’s vaccine committee is scheduled to meet on Tuesday, February 15 to review Pfizer’s EUA request. The committee will vote on recommending the authorization of Pfizer’s vaccine in children ages 6 months to 4 years old. After the meeting, the FDA will make the final call on if the vaccine should be authorized for this age group.
Before Pfizer’s vaccine can be available for this age group, a CDC expert panel will also need to vote. The panel is scheduled to meet on February 23 and 24. But it hasn’t been announced yet if they’ll be discussing Pfizer’s vaccine during this time. Similar to the FDA, the CDC will make the final call on recommending the vaccine for this age group.
FDA fully approves Moderna’s COVID-19 vaccine; Novavax submits EUA request for its COVID-19 vaccine
January 31, 2022
Spikevax now fully FDA-approved for adults ages 18 and older
Today, the FDA approved Moderna’s COVID-19 vaccine (known as “Spikevax”) for adults ages 18 and older. Spikevax is approved to be administered as two doses given 1 month apart.
Spikevax is the same formulation as the authorized Moderna COVID-19 vaccine. Both are also interchangeable. But the authorized vaccine still has an EUA in place for booster shots, additional doses, and mix-and-match shots with the other COVID-19 vaccines. Spikevax is approved for your initial two doses.
Novavax seeks authorization for its COVID-19 vaccine in adults ages 18 and older
Novavax announced today that it has submitted an EUA request to the FDA for its COVID-19 vaccine. The company is seeking emergency authorization for adults ages 18 and older.
The Novavax vaccine is administered as two doses given 21 days apart. In clinical trials, it was shown to be about 90% effective against symptomatic COVID-19.
Compared to the Pfizer, Moderna, and J&J COVID-19 vaccines, Novavax’s vaccine works differently. It uses nanoparticle technology to teach your immune system to make antibodies against the virus’ spike protein.
As of today, the FDA hasn’t announced a specific time for their vaccine advisory committee to review Novavax’s application.
Lower-dose Pfizer COVID-19 vaccine could be authorized for children under age 5 within the next month
January 21, 2022
Fauci predicts authorization timeline ahead of study findings
On Wednesday, Anthony Fauci, who serves as the chief medical advisor to the president, said that Pfizer’s COVID-19 vaccine could be authorized for children under age 5 “within the next month or so.” But Pfizer has yet to announce study results or request authorization for this age group.
Last month, Pfizer announced they would be adding a third dose to their study evaluating a lower-dose vaccine in children ages 6 months to under 5 years old. This is because the two-dose series failed to cause an adequate immune response in kids ages 2 to 4.
Depending on the success of a third dose, Pfizer plans to request authorization in the first half of 2022. This timeline could change, but Fauci is predicting that it’ll happen sooner rather than later.
So, will Pfizer’s vaccine be authorized for younger kids in the next month? Fauci hopes that it will be, especially since COVID-19 cases in kids are spiking. Currently, kids under age 5 are the only people unable to get vaccinated due to age.
FDA expands Pfizer COVID-19 vaccine authorization for young children and adolescents; Pfizer booster shot timeline shortened
January 4, 2022
Pfizer vaccine receives booster authorization for people as young as 12 years old
Yesterday, the FDA announced that people as young as 12 years old can now receive a Pfizer booster shot. Before this announcement, Pfizer booster shots were authorized for people ages 16 and older.
The CDC has yet to endorse this update, but a CDC expert panel is scheduled to meet tomorrow. The CDC hasn’t posted an official meeting agenda yet, but it’s possible that this update could be discussed in the meeting.
In addition to this, a third primary Pfizer shot is now authorized and recommended for immunocompromised people as young as 5 years old. Prior to this, a third primary shot for immunocompromised people only applied to those ages 12 and older.
Pfizer booster shot interval shortened to 5 months from 6 months
Yesterday, the FDA also announced that people can now receive a Pfizer booster shot 5 months after getting their second Pfizer dose. Previously, the recommendation was to wait 6 months before getting the extra shot.
Data shows that this shortened timeline can help improve protection against the Omicron variant, which is now the predominant variant in the U.S. The CDC endorsed this update today.
Pfizer requests full approval for COVID-19 vaccine in people ages 12 and older; CDC updates J&J vaccine recommendations
December 17, 2021
Pfizer requests to expand Comirnaty’s approval to include adolescents ages 12 to 15
Yesterday, Pfizer announced that they’ve requested full approval of their COVID-19 vaccine for adolescents 12 to 15 years old. The vaccine, known as Comirnaty, is currently FDA-approved to prevent COVID-19 in people ages 16 and older. It’s also authorized for use in children ages 5 to 15 years old.
The FDA has yet to schedule a vaccine advisory committee meeting to review Pfizer’s request.
CDC endorses Pfizer and Moderna COVID-19 vaccines over J&J vaccine
A CDC expert panel met yesterday and reviewed updated information about the rare but serious blood clotting issues linked to the J&J vaccine. As a result of the discussion, the panel is recommending the Pfizer and Moderna COVID-19 vaccines over the J&J vaccine for initial and booster shots.
Yesterday, the CDC endorsed the expert panel’s recommendation.
However, some people may have serious allergic reactions to the Pfizer and Moderna vaccines. Others may not want to receive either vaccine. In this case, the J&J vaccine is still an available option in the U.S.
FDA and CDC authorize booster shots for 16 and 17 year olds
December 10, 2021
People ages 16 and older now eligible for a Pfizer booster 6 months after their initial shots
This week, the FDA authorized Pfizer’s COVID-19 vaccine for booster shots in teens ages 16 and 17. The CDC followed the FDA’s authorization with a similar recommendation.
According to the CDC, this age group can get a Pfizer booster shot 6 months after completing the initial Pfizer vaccine series. By comparison, adults ages 18 and older should get a booster shot.
The Moderna and J&J vaccines aren’t authorized in people under 18, so they aren’t booster options in this age group.
Boosters could be authorized for adolescents ages 16 to 17 years old in the coming weeks
December 1, 2021
Pfizer requests booster authorization for people as young as 16 years old
Yesterday, Pfizer’s CEO announced that the company has submitted an authorization request for COVID-19 booster shots in people as young as 16 years old. Booster shots with Pfizer’s COVID-19 vaccine are currently recommended for all adults age 18 and older, depending on when they finished their initial vaccination series.
Pfizer’s vaccine is the only one authorized for use in people under 18 years old. That means people as young as 16 years old could be eligible for a booster 6 months after their second shot.
It’s been reported that authorization for this age group could happen within a week. After the FDA issues a decision, the CDC will need to weigh in with recommendations, too.
Pfizer and Moderna booster shots authorized for use in all adults
November 22, 2021
FDA and CDC sign off on Pfizer and Moderna boosters for all adults
Last week, the FDA authorized the expansion of single-dose Pfizer and Moderna booster shots for all adults. The CDC has also issued the same recommendation.
This latest announcement means that the following people are eligible for booster shots with the Pfizer or Moderna COVID-19 vaccine:
Adults who completed their initial Moderna vaccine series at least 6 months ago
Adults who completed their initial Pfizer vaccine series at least 6 months ago
Adults who initially got the single-dose J&J vaccine at least 2 months ago
COVID-19 vaccine booster recommendations allow for “mixing and matching” vaccines. This means that if you initially got Pfizer, you can get Moderna. Or you can stick with Pfizer again for your booster. The same applies to people who initially got the Moderna vaccine. Keep in mind that the Moderna booster is a half-dose shot compared to the initial doses.
Pfizer COVID-19 booster shots for all adults may be authorized within the next few weeks
November 10, 2021
Pfizer submits authorization request to expand booster eligibility to all adults
Yesterday, Pfizer submitted an authorization request to the FDA to expand its COVID-19 vaccine booster eligibility to all adults at least 18 years old. Currently, Pfizer booster shots are only authorized for certain groups, including older adults and people at high risk for severe illness.
Pfizer is now requesting broader authorization based on clinical trial results that studied the effects of booster shots. The trial enrolled more than 10,000 participants.
Everyone in this study received two doses of the Pfizer vaccine, but some people also received a booster shot. During the study, more people who didn’t get a booster shot developed COVID-19 compared to those who got one.
As of today, there’s no FDA vaccine expert panel meetings scheduled to review Pfizer’s request. But it has been reported that the FDA could make the call without the panel before Thanksgiving.
Ocugen requests authorization for COVID-19 vaccine in children as young as 2 years old
November 8, 2021
Ocugen seeks COVID-19 vaccine authorization in people ages 2 to 18
Last week, Ocugen announced that it had submitted an EUA request to the FDA for its COVID-19 vaccine in people ages 2 to 18. The vaccine is not yet available in the U.S.
Ocugen’s vaccine is currently authorized in 17 other countries, and the World Health Organization has also given it emergency use status. Over 100 million doses have been given to adults so far. It’s known as Covaxin overseas, and it’s given as 2 shots 28 days apart.
Ocugen’s vaccine works differently from the other COVID-19 vaccines available in the U.S. It contains an inactivated (dead) version of SARS-CoV-2, the virus that causes COVID-19. The virus is dead, so you can’t get COVID-19 from the vaccine. The other COVID-19 vaccines don’t contain SARS-CoV-2.
If authorized, Ocugen’s vaccine may become the first COVID-19 vaccine available in the U.S. for children as young as 2 years old. But this depends on whether Pfizer’s vaccine is authorized in children as young as 6 months first.
Of note, Ocugen didn’t request authorization for use in adults — only children and adolescents.
FDA authorizes Pfizer’s COVID-19 vaccine in children ages 5 to 11 and delays decision on Moderna’s vaccine in adolescents
November 3, 2021
FDA and CDC sign off on Pfizer vaccine in children ages 5 to 11
This week, both the FDA and the CDC endorsed Pfizer’s lower-dose COVID-19 vaccine in younger children. This latest authorization allows children ages 5 to 11 to receive the Pfizer vaccine.
Children will also need to get two shots 3 weeks apart to be considered fully vaccinated. But it’s a 10 mcg dose instead of the 30 mcg dose given to anyone at least 12 years old.
Vaccination sites, like Walgreens and CVS, are already starting to schedule appointments for kids. You may be able to find one as early as later this week. But doses should be more readily available starting next week.
FDA may not review Moderna’s authorization request for adolescents until January 2022
In June, Moderna requested authorization for its COVID-19 vaccine to be used in adolescents ages 12 to 17. But the FDA needs additional time to review recent international data to make sure it’s safe in this younger age group. This is due to the vaccine being linked to rare cases of myocarditis (heart inflammation) and pericarditis (heart lining inflammation) in younger males.
The FDA recently notified Moderna that their review may not be complete until January 2022. However, adolescents still have at least one COVID-19 vaccine option in the interim. Earlier this year, Pfizer’s vaccine was authorized for use in adolescents ages 12 to 15 years old.
FDA expert panel recommends Pfizer’s COVID-19 vaccine for children ages 5 to 11
October 27, 2021
FDA’s vaccine advisory committee votes on recommending a lower-dose Pfizer vaccine in children ages 5 to 11
This week, the FDA’s vaccine advisory committee met to discuss Pfizer’s vaccine data for children ages 5 to 11. The committee voted in favor of authorizing the vaccine in this age group. The final vote was 17 members in favor of recommending the vaccine and 1 member who abstained from voting.
Pfizer’s COVID-19 vaccine is given as 2 doses, 3 weeks apart. But children in this age group get a lower dose than what’s given to people at least 12 years old.
Even though the advisory committee came to this vote, the FDA still needs to weigh in with its decision to authorize the vaccine. A CDC expert panel is also scheduled to meet next week to give their recommendations. As soon as both agencies sign off on the vaccine, the Biden administration has announced plans to help distribute shots quickly across the country.
All three COVID-19 vaccines now authorized for boosters
October 22, 2021
FDA and CDC also endorse Moderna, J&J, and ‘mix-and-match’ booster shots
This week, the FDA and the CDC backed their respective expert panel recommendations on COVID-19 booster shots. The latest announcement authorizes all three COVID-19 vaccines for boosters.
The following groups are eligible for a booster if they originally received the Pfizer or Moderna COVID-19 vaccines and are at least 6 months from their initial vaccine series:
People at least 65 years old
Adults living in long-term care settings (e.g., nursing homes)
Adults with underlying medical conditions
Adults who live or work in a setting where they’re frequently exposed to COVID-19
Unlike Pfizer’s vaccine, the Moderna booster shot is a lower dose compared to the original vaccine series. This means that you’ll receive a half-dose shot for your booster.
The J&J vaccine is authorized for boosters in any adult who is at least 2 months out from their initial J&J vaccine series.
Additionally, the vaccines are authorized for mix-and-match booster doses. This means that you can get a vaccine that’s different from what you got originally. For example, someone who initially received the J&J vaccine can get the Pfizer or Moderna vaccine for their booster dose.
FDA expert panel recommends Moderna and J&J boosters for specific people
October 18, 2021
FDA’s vaccine advisory committee votes on Moderna and J&J boosters
Last week, the FDA’s vaccine advisory committee met to discuss potential booster doses of the Moderna and J&J COVID-19 vaccines. The committee voted unanimously in favor of authorizing both vaccine boosters. But they decided these vaccine boosters should be used in different situations.
The Moderna booster is a half-dose version of the initial shots. The committee voted to recommend it for similar groups as Pfizer’s booster shot. This includes people who are at least 6 months out from their initial vaccine series and are:
Age 65 and older
Ages 18 to 64 and are at high risk for severe COVID-19
Working or living in places where they’re frequently exposed to COVID-19 (e.g., healthcare workers)
The J&J booster is the same dose as the first shot. But unlike Pfizer and Moderna, it’s being recommended for a broader group of people. This includes any adult who is at least 2 months out from their initial dose.
The National Institute of Allergy and Infectious Diseases (NIAID) also presented initial results of a mix and match booster study during the meeting. But there’s yet to be official guidance on if you can (or should) get a booster shot that’s different from the vaccine you got originally.
Recommendations won’t be finalized until the FDA and CDC weigh in. An FDA decision is expected shortly, and the CDC’s expert panel is scheduled to discuss COVID-19 vaccines on October 21.
FDA vaccine advisory committee to review Moderna and J&J boosters and Pfizer data for children ages 5 to 11 years old
October 6, 2021
Moderna and J&J boosters up for review on October 14 and 15
The FDA recently announced that they’ve scheduled a vaccine advisory committee meeting for October 14 and 15. During the meeting, the committee plans to discuss Moderna and J&J COVID-19 booster vaccines. This is welcome news to those who received those vaccines, since only Pfizer’s vaccine has been authorized for booster doses so far.
The committee will vote on whether to recommend authorizing booster doses for the two vaccines. The FDA will still need to issue a final decision. But their decision is usually in line with the vaccine advisory committee’s decision. Shortly after, a CDC expert panel will meet to determine specific booster recommendations.
Mixing and matching vaccines also on the agenda
In addition to reviewing Moderna and J&J boosters, the committee will also discuss the available data on mixing and matching the COVID-19 vaccines. Mixing and matching means that you were initially vaccinated with one vaccine (e.g., J&J) and you receive a different one (e.g., Pfizer) as a booster dose.
The data will be presented by the National Institute of Allergy and Infectious Diseases (NIAID). NIAID began studying mixing and matching vaccines in June. Early results were expected in late summer.
FDA schedules meeting in advance of Pfizer’s authorization request for children ages 5 to 11 years old
Last week, Pfizer began submitting vaccine data to the FDA for children ages 5 to 11. The company also said that they soon plan to submit an authorization request for their vaccine for this group. This announcement followed findings in late September that showed that the vaccine was safe and caused a strong immune response in this population.
In anticipation of Pfizer’s request, the FDA has scheduled a vaccine advisory committee meeting for October 26. During the meeting, the committee plans to review Pfizer’s vaccine data for this age group, which uses a lower dose than what’s currently available.
CDC backs Pfizer booster shots for certain populations
September 24, 2021
CDC recommends Pfizer booster shots for certain people, but Moderna and Johnson & Johnson booster shots not yet recommended
Today, the CDC announced that Pfizer booster shots are recommended for certain populations.
This recommendation follows a meeting from yesterday by a CDC expert panel. This panel discussed and voted on the potential risks and benefits of a booster shot. Today, CDC Director, Dr. Rochelle Walensky, formally announced the agency’s endorsement of the Pfizer COVID-19 vaccine booster shot.
A few groups of people now qualify for a Pfizer booster shot at least 6 months after their second dose. This includes:
People 65 or older
People between 50 and 64 who have certain medical conditions, such as asthma, kidney disease, or diabetes
People living in long-term care facilities (e.g., nursing homes)
Other people may qualify for a booster shot depending on the situation. If a healthcare provider decides that the benefits of a booster shot outweigh its risks, they can give a booster shot to certain people at least 6 months after their second dose. This group includes:
People between 18 and 49 who have certain medical conditions, such as asthma, kidney disease, or diabetes
People between 18 and 64 who work in a setting where they’re frequently exposed to COVID-19 (e.g., healthcare workers)
This information only applies to the Pfizer vaccine — not the Moderna or Johnson & Johnson vaccines. A Pfizer booster shot can help improve protection against COVID-19 for certain people. If you have questions, please reach out to your healthcare provider for additional guidance.
FDA authorizes Pfizer booster shot for specific populations
September 23, 2021
Pfizer booster authorized for older adults, people with high exposure risk, and those at risk for severe COVID-19
Yesterday, the FDA authorized a single booster dose of Pfizer’s COVID-19 vaccine for special populations. This announcement follows their expert panel’s decision last week to authorize booster shots for certain groups — without approving them for the general public.
The panel debated whether or not boosters are needed right now, considering data shows that the vaccines are still very effective at preventing hospitalization and death from COVID-19. Given the limited data on boosters, the FDA agreed that the known benefits outweigh the risks for higher-risk groups — but not for the general public — at this time.
Under the authorization, the following groups would be eligible for Pfizer boosters at least 6 months after their initial shots:
Adults at least 65 years old
Adults at high risk for severe COVID-19
Adults with frequent exposure to COVID-19 through their jobs or other settings (e.g., healthcare workers) that puts them at high risk for serious COVID-19 complications
A CDC expert panel is meeting today to discuss their recommendations for who should receive a booster shot, which may include additional information about:
Who is considered to be at high risk for severe COVID-19
What is considered to be frequent COVID-19 exposure
Expert panel votes in favor of Pfizer boosters in older adults and those at high-risk for severe COVID-19 but not general public
September 17, 2021
FDA’s vaccine advisory committee votes on Pfizer booster shots
Today, the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to discuss Pfizer’s application for COVID-19 vaccine booster shots in people at least 16 years old (also known as a supplemental Biologics License Application or sBLA). The VRBPAC is the FDA committee that reviews the safety and effectiveness of vaccines before they’re fully approved for use in the public.
Sixteen committee members voted against approving the application, and two members voted in favor of approval. This means that the committee recommended against approving the sBLA.
The decision was followed by a second vote to approve an EUA for booster doses in certain high-risk groups. These groups included adults at least 65 years old and people at high risk for severe COVID-19 who are at least 6 months out from their initial vaccine series. All 18 members voted in favor of the EUA, which may also include other groups with high COVID-19 exposure risk, like healthcare workers.
The FDA makes the final call, and they have yet to issue their decision. But if they follow the committee’s recommendation, it will likely include a booster EUA for specific groups.
A CDC expert panel will meet after the FDA’s decision to provide specific recommendations on who should receive a booster shot.
Pfizer’s vaccine may be authorized for children ages 5 to 11 by end of October
September 14, 2021
Children ages 5 to 11 may have a COVID-19 vaccine option by Halloween
Former FDA commissioner and current Pfizer board member, Dr. Scott Gottlieb, said in a recent interview that Pfizer should have clinical trial data ready by the end of September for children ages 5 to 11 years old. The company will then submit an EUA request to the FDA, which may be approved as early as the end of October if everything goes as planned.
Pfizer is currently studying a lower vaccine dose in this age group — 10 mcg per shot. People at least 12 years old are receiving 30 mcg of mRNA in each dose.
If authorized, this would give younger children a COVID-19 vaccine option as we approach colder months and the holiday season.
FDA to review Pfizer’s booster dose application, Moderna requests authorization for half-dose booster shot
September 2, 2021
FDA schedules advisory committee meeting to review Pfizer’s COVID-19 vaccine booster dose application
Last week, Pfizer announced they had started the supplemental Biologics License Application (BLA) submission process for a booster (third) vaccine dose in people at least 16 years old. They must submit the BLA to the FDA to get their booster dose approved for use.
A booster dose is currently authorized for certain immunocompromised people, but the supplemental BLA would mean the booster dose is fully approved for use for all people ages 16 and older. The company was expected to complete the submission process by the end of last week.
Since then, the FDA has announced that its Vaccine and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on September 17 to review Pfizer’s booster application. The booster shot may be approved shortly after that.
The VRBPAC meeting is scheduled just a few days before September 20, the target date announced by the Biden administration for when booster doses would be offered to the general public. People would be eligible for a booster shot once they were at least 8 months out from completing their initial two-dose series. However, this date was dependent on getting final sign-off from the FDA and the CDC beforehand.
Once the FDA approves the booster dose, the CDC’s Advisory Committee on Immunization Practices (ACIP) still needs to weigh in on their recommendations for use. This is done to help create more specific recommendations on who should use the vaccine and when.
Moderna requests FDA authorization for half-dose booster shot
Like Pfizer’s vaccine, Moderna’s COVID-19 vaccine is also authorized for a booster dose in certain immunocompromised people. This week, it’s been reported that the company has also requested FDA authorization for a half-dose booster for people eligible to get the vaccine. The original Moderna vaccine contains 100 mcg of mRNA, whereas the booster would contain 50 mcg.
Although the VRBPAC meeting on September 17 will be focusing on additional COVID-19 doses — including Pfizer’s booster application — the FDA announcement doesn’t specify if Moderna’s booster application will also be reviewed. However, we’ll know more once the meeting agenda is made available to the public — no later than 2 business days before the meeting.
Moderna applies for full FDA approval for its COVID-19 vaccine
August 25, 2021
Moderna COVID-19 vaccine application submitted for full approval
Today — just two days after the FDA fully approved Pfizer’s COVID-19 vaccine — Moderna has submitted their completed Biologics License Application (BLA) to the FDA, in which they seek full approval for their COVID-19 vaccine in people 18 years and older. The pharmaceutical company has been submitting BLA information to the FDA since June.
It’s not known when the FDA will be able to potentially approve Moderna’s COVID-19 vaccine. The FDA is reviewing the application under Priority Review — meaning they will review it in an accelerated time frame — but it still may take months.
Moderna’s COVID-19 vaccine was originally allowed to be used in adults ages 18 and older through an EUA in December 2020. In June, after completing a study in over 3,700 adolescents, Moderna also requested that the FDA update their EUA to allow the vaccine to be used in children 12 years and older. At this time, the FDA is still reviewing this request.
Read more about Moderna’s COVID-19 vaccine approval submission here.
FDA fully approves first COVID-19 vaccine
August 23, 2021
Pfizer’s COVID-19 vaccine gets full FDA approval
Today, the FDA fully approved Pfizer’s COVID-19 vaccine — making it the first fully approved COVID-19 vaccine and messenger RNA (mRNA) vaccine. The vaccine is to be marketed under the name “Comirnaty.”
Since December, Pfizer’s vaccine has been approved to prevent COVID-19 in people at least 16 years old under an emergency use authorization (EUA).
Although the FDA has also issued EUAs for adolescents (ages 12 to 15) and booster doses for certain people who are immunocompromised, these groups were not included in Pfizer’s application for full FDA approval. However, they can still access the vaccine under the existing EUA.
Read more about Pfizer’s COVID-19 vaccine approval here.
Pfizer approval timeline moved up, Moderna starts submission process, J&J expected to file for full approval late 2021
August 9, 2021
Pfizer COVID-19 vaccine approval expected early September
Last month, Pfizer announced that the FDA granted Priority Review designation for their COVID-19 vaccine Biologics License Application (BLA) — the application to fully approve the vaccine. This means that the application is prioritized, shortening the FDA’s review time from 10 months to 6 months.
At the time of the announcement, the FDA’s decision wasn’t expected until January 2022. However, it was recently reported that the FDA is now targeting approval in early September — with an unofficial deadline of September 6.
As of yet, the FDA committee that determines the safety of vaccines, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), hasn’t posted a meeting date for when they’ll be discussing Pfizer’s application.
Moderna begins filing for FDA approval of COVID-19 vaccine
In early June, Moderna announced that they had started submitting their COVID-19 vaccine BLA to the FDA. Like Pfizer, they’ve requested Priority Review designation.
Since Moderna’s vaccine was granted the Fast Track designation last year, they’re able to submit sections of the application as they are completed — called a rolling review — rather than all at once. This helps lower the application’s review time.
Once the BLA submission is complete, the FDA will notify them when it’s been accepted for review.
Johnson & Johnson expected to file for approval later in 2021
The Johnson & Johnson (Janssen) COVID-19 vaccine was authorized more recently than the Pfizer and Moderna vaccines, so the company has yet to begin the BLA submission process. However, in late April, they said that they plan to file their application later this year.
The bottom line
Why trust our experts?
The best way to protect yourself and those around you from serious illness is to get vaccinated against COVID-19. And if you’ve been hesitant to get the shot until it’s fully approved, you’re now able to get the FDA-approved Pfizer vaccine.
Check back with GoodRx for the latest news on COVID-19 vaccine approvals, safety, efficacy, and more.
