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Americans Start Receiving Pfizer's COVID-19 Vaccine

Americans Start Receiving Pfizer's COVID-19 Vaccine

About 2.9 million doses of the vaccine are being distributed across the United States.

Updated on December 13, 2020 at 1:17pm EST.

A vaccine to help put an end to the coronavirus pandemic is now available in the United States. U.S. Centers for Disease Control and Prevention (CDC) Director, Robert Redfield, MD, has accepted the recommendation of the agency’s Advisory Committee on Immunization Practices (ACIP) that the Covid-19 vaccine developed by Pfizer and the German drugmaker, BioNTech, may be given to people ages 16 and older. The CDC also recommends that healthcare workers and long-term care facility residents be vaccinated first.

On Friday December 11, the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) of the COVID-19 mRNA vaccine, known as BNT162b2.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, MD, in an agency news release.

The following day, the ACIP voted to recommend the Pfizer and BioNTech coronavirus vaccine for people ages 16 and older and add it to the vaccine schedule.

Taking the final step needed to ensure that Americans could start receiving the shot, on Sunday December 13, the CDC accepted the ACIP's recommendation and approved the vaccine. 

It’s the first COVID-19 vaccine to receive a green light for use in the United States. The vaccine is already being rolled out in the UK and it has been approved for use in Canada as well.

New COVID cases are surging
The U.S. approval comes as new COVID-19 cases are surging across the country. More than 288,000 Americans have already died from the disease. As of December 9, the Centers for Disease Control and Prevention (CDC) is projecting that the number of newly reported coronavirus-related deaths could reach 362,000 by January 2. 

During a public health crisis, like the pandemic, the FDA has the power to issue an EUA. It’s a way to allow the immediate use of a vaccine or therapy before it’s formally approved as long as certain criteria about its safety and effectiveness have been met.

The decision came on the heels of a December 10 meeting of the Vaccines and Related Biological Products Advisory Committee—an independent group of experts that advised the agency to grant an EUA of the experimental vaccine.

The committee, which includes independent vaccine experts, infectious disease specialists, industry representatives and a consumer representative, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people age 16 and older.

The EUA of Pfizer’s two-dose vaccine allowed shipping to begin but Americans couldn't start receiving the shot until the ACIP recommended the vaccine and the CDC cleared the final hurdle, issuing its approval.

Some questions, however, still remain, including how long protection will last. It's also unclear if the vaccine will prevent infections that don't cause symptoms, which could unknowingly be spread to others who aren't vaccinated.

What happens now?
An initial shipment of about 2.9 million doses will reportedly be distributed across the United States, with the first doses being given as early as Monday, Decemebr 14.

Four states have been selected by Pfizer to help streamline their plan for the delivery and distribution of their COVID-19 vaccine: Rhode Island, Texas, New Mexico, and Tennessee.

In a November 16 news release, the company announced it is launching this U.S. pilot program to help states administer the vaccine. Lessons learned from these four states will be applied to other states to help them fine tune their vaccination programs.

Pfzier says these four states were chosen because they vary in size and immunization infrastructure, have diverse populations and both rural and urban communities. These states will not receive vaccine doses earlier than others.

Overall, Pfizer and BioNTech expect to produce up to 50 million doses of their vaccine around the world in 2020. Looking ahead to 2021, the companies plan to make as many as 1.3 billion doses.

Vaccine trials are ongoing
The Phase 3 clinical trial of the experimental vaccine began on July 27. As of November 18, 43,661 participants have enrolled. Of these participants, 42 percent have diverse backgrounds.

The Pfizer and BioNTech vaccine calls for two doses, three weeks apart. The companies announced the first set of complete results from their ongoing coronavirus vaccine trial in November, which showed it is 95 percent effective against COVID-19, starting 28 days after the first dose.

For adults older than 65, the vaccine has been shown to be 94 percent effective.

The results were based on an evaluation of 170 confirmed cases of COVID-19 with 162 observed in the placebo group compared to 8 in the vaccine group. The effectiveness of the vaccine was similar for both men and women and people of different races and ethnicities.

The most common side effects of the vaccine seemed to be short-lived and included pain, redness or swelling at the injection side, fatigue, muscle aches, joint aches, chills and headache. But there have been reports that side effects may be more intense than a sore arm commonly experienced after a flu shot.

No serious safety concerns have been reported in the U.S. trials. But the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has reported two incidents of a severe allergic reaction, called anaphylaxis, and another possible case of an allergic reaction since their rollout of the vaccine began. The MHRA issued a warning, advising those with a history of anaphylaxis to a vaccine, medicine or food to not receive the Pfizer vaccine.

After granted the EUA, the FDA concluded, "the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals." The FDA added that it can "assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information."

Continued safety monitoring
In October 2020, the FDA said that to receive an EUA, companies must submit at least two months of follow-up data. Because side effects associated with vaccination usually crop up within six weeks of vaccination, the two-month requirement was considered long enough to identify short-term adverse events related to the vaccine. 

When submitting an experimental vaccine to the FDA for EUA, Pfizer and other drug companies must outline a plan for active follow-up to monitor the long-term safety of their vaccine. This includes keeping track of any adverse events, such as hospitalizations, and other serious reactions. This follow-up data is needed for the ongoing support of an EUA.

Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by the FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist.

More about the vaccine
BNT162b2 is an mRNA vaccine. It works by delivering pieces of genetic material that carry instructions for making the COVID-19 spike protein—the protein that the coronavirus (SARS-CoV-2) uses to infect cells.

The mRNA is packaged inside a slippery coating that allows it to slide into cells and tell them to make the spike protein—without causing disease. This prompts an immune response to protect people from catching COVID-19.

Pfizer’s experimental vaccine must be stored in an ultra or deep freezer at about -94° F in order to remain effective. The company noted that this is a potential complication to its widespread distribution.

Pfizer addressed this concern, however, in a November 18 new release, stating that it has the experience, knowledge and existing cold-chain infrastructure to safely distribute the vaccine on a global scale.

The company says it has developed specially designed, temperature-controlled thermal shippers that use dry ice to maintain the necessary ultra-low temperatures.

These shipping units can be used as temporary storage of the vaccine for up to 15 days if they are refilled with dry ice. Each unit is equipped with a heat sensor to track its location and temperature during shipment.

Dry ice is made by compressing and cooling liquid carbon dioxide, but liquid carbon dioxide is currently in short supply.

Most carbon dioxide in the United States is captured during ethanol and ammonia production, which is low due to plant closures. Demand for dry ice has also surged as more Americans are relying on home delivery of frozen groceries, according to the American Chemical Society.

Medically reviewed in December 2020.

Sources:
U.S. Centers for Disease Control and Prevention. “ACIP Presentation Slides: December 11 and 12, 2020 Meeting.” Dec 12, 2020.
U.S. Food and Drug Administration. "FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine." Dec 11, 2020.
U.S. Centers for Disease Control and Prevention. "COVID-19 Forecasts: Deaths" Dec 9, 2020.
Pfizer. “PFIZER AND BIONTECH ACHIEVE FIRST AUTHORIZATION IN THE WORLD FOR A VACCINE TO COMBAT COVID-19.” Dec 2, 2020.
U.S. Food and Drug Administration. “Emergency Use Authorization for Vaccines Explained.” Nov 20, 2020.
U.S. Food and Drug Administration. “Roster of the Vaccines and Related Biological Products Advisory Committee.” Oct 28, 2020.
Pfizer. “PFIZER AND BIONTECH TO SUBMIT EMERGENCY USE AUTHORIZATION REQUEST TODAY TO THE U.S. FDA FOR COVID-19 VACCINE.” Nov 20, 2020.
U.S. Centers for Disease Control and Prevention. “ACIP Meeting Information.” Dec 9, 2020.
U.S. Centers for Disease Control and Prevention. “ACIP Recommendations.” Nov 10, 2020.
Pfizer. “PFIZER UPDATE ON OUR U.S. COVID-19 VACCINE CANDIDATE
DISTRIBUTION PREPAREDNESS.” Nov 16, 2020.
Pfizer. “PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS.” Nov 18, 2020.
UK Medicines and Healthcare Products Regulatory Agency. “Confirmation of guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine.” Dec 9, 2020.
U.S. Food and Drug Administration. “Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry.” Oct 2020.
Philip R. Krause, M.D., and Marion F. Gruber, Ph.D. Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations. N Engl J Med 2020; 383:e107.
American Chemical Society. “Short CO₂ supply may complicate COVID-19 vaccine rollout.” Nov 19, 2020.

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