FDA Gives Emergency Approval for Pfizer COVID-19 Vaccine: What to Know
Distribution of the Pfizer-BioNTech coronavirus vaccine in the United States can begin, with healthcare workers and long-term care residents first in line to be vaccinated.
The Pfizer-BioNTech coronavirus vaccine received emergency approval Friday from the Food and Drug Administration (FDA) for use in people 16 years and older.
The approval makes it the first vaccine to reach this milestone in the United States.
This opens the door for healthcare workers and long-term care residents to begin receiving the first doses of the vaccine early next week.
Emergency approval of the vaccine gives the United States another tool for reversing the surge in COVID-19 cases and deaths.
The COVID Tracking Project, which monitors state-level coronavirus data, reported 3,067 COVID-19-related deaths on Thursday. This is the country’s highest 1-day toll since the start of the pandemic.
To date, more than 294,000 people have died from COVID-19 in the United States.
In addition, many people, even those who had only mild illness in the beginning, could take a year or longer to fully recover, some experts say.
These COVID-19 “long haulers” experience ongoing symptoms such as fatigue, shortness of breath, and brain fog.
Although approval of the vaccine marks a major milestone in the United States’ fight against the pandemic, rollout of the vaccine is expected to take months, with doses limited in the beginning.
On the other hand, the phase 3 clinical trials didn’t show whether the vaccine can prevent asymptomatic infection or keep people from transmitting the virus to others.
So preventive measures, such as mask wearing and physical distancing, will be needed well into next year to help slow the spread of the virus and enable the country to resume its normal activities.
With the emergency approval, the hard work of getting the vaccine to those who need it most begins.
Many health experts emphasize that vaccines don’t save lives — vaccination does.
By the end of this month, 6.4 million doses of the Pfizer-BioNTech vaccine will be available in the United States, according to federal officials.
About half of those doses will begin shipping to states within 24 hours of the FDA’s emergency approval. The rest will be distributed later when the initial recipients are due to receive their second dose about 3 weeks later.
Preparation for distribution began months ago with coordination between federal and local health officials, as well as with healthcare systems and pharmacy chains.
Getting the initial and follow-up doses into people’s arms is complicated by the need for the vaccine to be stored in freezers at ultralow temperatures (-80°C/-112°F).
That means only a small number of facilities are able to handle and distribute the vaccine.
In addition, the minimum order for the vaccine is 975 doses, which may pose a challenge for areas that don’t have that many high-risk people to vaccinate.
An advisory committee for the Centers for Disease Control and Prevention (CDC) voted last week to recommend that healthcare workers and residents of nursing homes and other long-term care facilities be first in line to receive the vaccine.
States aren’t required to follow the CDC’s recommendation, but many have indicated that they will.
As more doses of the vaccine become available, other high-priority groups will be able to get vaccinated.
Next up will likely include police, firefighters, food and agriculture workers, and other essential workers. They’d be followed by people with underlying health conditions that increase their risk of severe COVID-19.
The United States has ordered enough of the Pfizer-BioNTech vaccine to vaccinate 50 million people, according to Forbes.
Over the summer, the Trump administration passed on a chance to secure additional doses, according to a New York Times report.
This could leave the United States waiting in line behind other countries that have also preordered the vaccine.
The Trump administration has contracts with five other vaccine candidates.
One of these is Moderna’s, which the FDA is expected to authorize later this month for emergency use. The FDA’s advisory committee meets on
Moderna was part of the U.S. federal government’s Operation Warp Speed program, a multibillion dollar program to fast-track the development of a coronavirus vaccine.
Pfizer chose to go it alone and didn’t receive U.S. funding to help it develop its vaccine.
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The emergency approval comes after an independent advisory committee met on Thursday to discuss data from the Pfizer-BioNTech phase 3 trial.
The FDA had been expected to make a decision Saturday morning.
But earlier Friday, White House chief of staff Mark Meadows told FDA Commissioner Dr. Stephen Hahn to submit his resignation if the vaccine wasn’t approved by the end of Friday, The Washington Post reported.
Hahn later said the story was not true.
“This is an untrue representation of the phone call with the Chief of Staff,” Hahn said in a statement send to the Post. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”
The advisory committee, composed of independent scientific experts, infectious disease doctors, and statisticians, voted 17 to 4 in favor of the emergency approval. (The vote had one abstention.)
While the FDA isn’t required to follow the recommendation of the advisory committee, it generally does.
Meadows’ statement marks another salvo in the ongoing battle between President Donald Trump — who long pushed for a coronavirus vaccine to be approved before Election Day — and the FDA’s Hahn, who has fought to uphold the agency’s high standards for drug reviews.
The approval marks a significant milestone. The work on vaccines to protect against SARS-CoV-2 (the virus that causes COVID-19) started 11 months ago after Chinese researchers sequenced the virus’s genome.
While some people have raised concerns that the vaccine development was rushed, the process was aided by an influx of funding and a streamlining of regulatory processes.
In addition, the many coronavirus hotspots in the United States and other countries enabled Pfizer to accumulate cases of COVID-19 more quickly to reach the study’s goals.
Dr. Peter Hotez, PhD, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said in an interview with MSNBC that the development of the coronavirus vaccine began even before the emergence of COVID-19.
“Sometimes people think that these vaccines just popped out of nowhere over a period of 4 months,” Hotez said. But “this is not a 4-month process. This is a 17-year process.”
Research on pandemic-causing coronaviruses and vaccines to protect against them began after the emergence of a related virus that caused the SARS outbreak in 2003.
Later, scientists worked on vaccines to protect against the coronavirus that causes Middle East respiratory syndrome (MERS), which was first seen in 2012.
During the advisory committee meeting on Thursday, panel members pored over
The data showed that, 7 days after the second dose was given, the vaccine had an effectiveness of 95 percent.
Efficacy is a measure of how well a vaccine works in a clinical trial. Real world effectiveness may be lower.
Similar effectiveness was found in older and younger adults, as well as among a variety of demographic groups and among people with other conditions, such as obesity, diabetes, and heart disease.
The FDA’s premeeting analysis found “no specific safety concerns identified that would preclude issuance of an EUA,” or emergency use authorization.
The most common adverse effects experienced by trial participants were pain at the site of injection, fatigue, headache, muscle pain, chills, joint pain, and fever.
A more serious side effect that occurred in some participants was swollen lymph nodes, which the FDA said is likely the result of the vaccine.
Four people who received the vaccine developed Bell’s palsy, a condition that causes weakness or paralysis of muscles in the face. FDA scientists said the rate of this was not higher than what occurs in the general population.
However, the FDA recommended ongoing monitoring for this condition among people who receive the vaccine.
This type of monitoring routinely occurs after a vaccine receives emergency or full approval. A number of government systems are already in place to track side effects among vaccine recipients.
In the United Kingdom, two healthcare workers developed symptoms of severe allergic reactions after getting the vaccine. Both had a history of serious allergic reactions, and each carried an epinephrine autoinjector.
They’re recovering well, the U.K. regulatory agency reported.
The agency also advised, on a precautionary basis, that people “with a significant history of allergic reactions” avoid getting the Pfizer/BioNTech vaccine until further study is done.
U.K. regulators approved the Pfizer-BioNTech vaccine for emergency use last week, with the first vaccinations occurring on Tuesday. Canada’s regulatory agency followed with its own emergency approval earlier this week.
The FDA emergency approval of the vaccine doesn’t signal the end of clinical trials. Pfizer will continue to follow participants for up to 2 years both for signs of other safety issues and to see if the protection offered by the vaccine lasts.
Several questions about the vaccine remain, including whether the vaccine protects against asymptomatic infections, whether it can prevent people from spreading the virus to others, and how long the protection lasts.
In addition, other clinical trials or more data will be needed before the FDA can recommend the vaccine for use in people under age 16, pregnant women, and people with weakened immune systems.
Pfizer said it plans to seek full approval of its vaccine from the FDA in April 2021. By then, it will have collected 6 months of safety data.
If the FDA grants full approval, Pfizer would be able to sell its vaccine to hospitals, pharmacies, and other healthcare providers.
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