Key takeaways:
The FDA authorized the first COVID-19 vaccine by Pfizer/BioNTech, which can be used in people who are at least 16 years old.
A total of 2.9 million doses of the vaccine are being delivered to administration sites this week, with another 2 million expected next week.
Healthcare workers across the country are already starting to receive initial doses of the vaccine.
In a significant step towards battling the COVID-19 pandemic, the FDA has authorized Pfizer and its partner BioNTech’s vaccine. Shortly after authorization, shipments of the vaccine were deployed across the country, with the first doses being administered this week to healthcare workers on the front lines.
With a 95% efficacy rate, the vaccine is the first of its kind to be authorized in this country. And last week, the FDA gave the green light for its use in people who are at least 16 years old.
But does this mean that the vaccine is FDA-approved? Not yet. Here we’ll cover what the authorization means, and what you need to know about the vaccine.
What does ‘emergency use authorization’ mean?
Under normal circumstances, new drugs and vaccines go through the FDA approval process before they can be marketed and distributed in the United States.
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But in times of a public health emergency, the agency can authorize unapproved products for temporary use under what is called an emergency use authorization (EUA). The secretary of the Department of Health and Human Services (DHHS) makes the call for when the FDA has this ability in what is called an EUA declaration.
A few examples of EUAs that have been granted during the COVID-19 pandemic include:
Diagnostic and antibody tests for COVID-19
Treatments like remdesivir (now FDA approved), monoclonal antibodies, and convalescent plasma
While an EUA grants temporary use, it is also possible that these products can eventually become FDA approved, too. This was the case with remdesivir, a medication used to treat COVID-19 in hospitalized patients.
But EUAs don’t last forever, and the FDA can also change or revoke them at any time. As soon as the secretary ends the EUA declaration, all EUAs that have been issued are no longer in effect.
Does this mean the COVID-19 vaccine is ‘FDA approved’?
At least right now, the FDA has not approved the COVID-19 vaccine, and it is allowed to be distributed under an EUA. But this does not mean that it isn’t effective, or that safety checks weren’t part of the process.
How is an EUA different from FDA approval?
When the FDA approves a vaccine, this means that the agency has determined that it is safe and effective for its intended use, and that the benefits outweigh the risks. The FDA makes this decision after an extensive review of clinical data and other evidence. They also make sure that the vaccine developer’s facility and manufacturing process meet federal requirements and standards. If a vaccine meets all of these requirements, the FDA approves a biologics license application (BLA).
But in an emergency, the FDA can allow the temporary use of a vaccine under an EUA. In this case, the agency reviews all best available evidence to determine whether the benefits outweigh the risks.
During the COVID-19 pandemic, vaccine developers had to provide evidence of the safety and efficacy of their vaccine candidates for an EUA, with a minimum standard of at least 50% efficacy in preventing the disease.
So how does the Pfizer vaccine stack up? The final human clinical trial results demonstrated that the vaccine was 95% effective in preventing symptomatic COVID-19.
Why did the FDA grant an EUA instead of approving the vaccine?
During a pandemic, time is of the essence. With over 100,000 new cases of COVID-19 every day, we need a vaccine now. Rather than have a vaccine go through the standard approval process which can take much longer, the EUA gives the public access to the vaccine sooner based on a review of best available evidence.
But this doesn’t mean that Pfizer won’t pursue FDA approval. They will continue the phase 3 clinical trials so that they can apply for licensing under a BLA for full approval in 2021.
What was the testing process for the Pfizer vaccine?
The Pfizer vaccine went through the typical testing steps of a vaccine, including phase 1, 2, and 3 clinical trials. The trials assessed immune response, dosing, safety, efficacy, and other factors across 44,000 participants. Almost half of the participants were in age groups known to be at higher risk for severe illness, and about 30% were people of color.
In the placebo group, 162 participants developed symptomatic COVID-19. This is compared to 8 in the vaccine group, which is where we get the 95% efficacy statistic. This means that symptomatic COVID-19 cases occurred 95% less frequently in the vaccinated group compared to the placebo group.
But what about safety? Short-term effects like mild-to-moderate pain where the vaccine was injected, fatigue, headache, chills, and fever were noted, and they were more frequent and stronger in younger people. However, overall, there were very few serious adverse events. Side effects and adverse events will continue to be monitored even after authorization.
Pfizer submitted an EUA application to the FDA based on the 95% efficacy rate, as well as safety information. A committee of independent experts reviewed the evidence and voted in support of the FDA approving the vaccine’s EUA request.
When can we get the Pfizer COVID-19 vaccine?
An expert panel that advises the Centers for Disease and Prevention (CDC) recommended that the first doses should go to healthcare workers and residents of long-term care facilities (LTCF). Other high-risk groups like essential workers, those with underlying conditions, and older adults were identified as part of a phased approach in distributing the vaccine.
Ultimately, each state makes the call as to who gets the vaccine first, as well as other details on how the vaccines are distributed. Many states seem to be following the CDC’s recommendations to start, but when you can expect to get vaccinated yourself may look different depending on where you are located. You can check your state’s vaccine rollout plan here.
An initial round of 2.9 million doses of the Pfizer vaccine is being delivered this week to administration sites across the country, with first doses already being given to healthcare workers on the front lines. An additional 2 million doses are expected to be shipped next week.
In total, the U.S. government has purchased 100 million doses of Pfizer’s vaccine, as well as 200 million doses of a vaccine by Moderna that is pending review and is expected to be authorized later this week.
What should I expect if I get the Pfizer vaccine?
The vaccine is currently authorized for use in people who are at least 16 years old, and it requires two shots, spaced 21 days apart. You’ll need to get both to make sure that you have a strong enough immune response to get the vaccine’s full benefit.
It is also possible that you’ll experience some short-term side effects, but they tend to be mild and go away on their own for most people. This is usually a sign that your immune system is responding to the vaccine. For some people, side effects may be more noticeable after the second shot.
Who shouldn’t get the Pfizer vaccine?
People who have a history of severe allergic reactions to any of the vaccine’s ingredients should not get the Pfizer vaccine. A few severe allergic reactions have been noted so far, including two healthcare workers in the United Kingdom and another in Alaska.
Other groups, like people who are pregnant or breastfeeding and those with compromised immune systems, should discuss the benefits and risks of the vaccine with their healthcare provider.
How soon will they be able to vaccinate everyone?
The Health and Human Services secretary recently said that the general public may be able to start getting doses of the vaccine as early as the end of February into early March. The government has also purchased 300 million doses to allow for continuous delivery through the end of June 2021. But this is assuming that everything goes right, so the timeline is subject to change.
If you don’t fall into one of the priority groups for the initial phases of vaccinations, you’ll likely get access sometime in 2021. Again, the exact timeline depends on decisions made by your state. Ideally, we’ll have additional vaccine candidates authorized next year, so there will be more options and doses available for those wanting to get vaccinated.
What other vaccines are close to emergency use authorization?
A few other vaccines may be authorized before the end of the year and early next year.
Moderna
Compared to Pfizer’s product, the Moderna vaccine uses a similar mechanism to generate an immune response, and it has similar efficacy. The FDA’s vaccine advisory committee is scheduled to review Moderna’s vaccine candidate this week, with authorization anticipated to happen as early as Friday. Assuming everything goes as planned, 5.9 million doses of the vaccine are expected to be shipped next week.
AstraZeneca
AstraZeneca’s vaccine candidate is less expensive to make and easier to store compared to the Pfizer and Moderna vaccines. But initial results from their trial generated questions about a dosing error. One group received a lower dose than intended, which resulted in higher efficacy (90%) compared to the group that received the correct dose (62%).
For now, results from the U.S. trial may be available in January, and the company may submit an authorization request sometime in February.
Johnson & Johnson
Johnson & Johnson’s vaccine candidate is currently in phase 3 clinical trials, and it uses a technology that is similar to AstraZeneca’s product. It is one of the promising vaccine candidates that is being studied as a one-dose regimen. Similar to AstraZeneca, the company could have results sometime in January, followed by an authorization request in February.
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