An Overview of Pfizer's COVID-19 Vaccine

Pfizer's joint effort with BioNTech was the first vaccine approved in the U.S.

Pfizer’s BNT162b2 mRNA Covid-19 vaccine was the first vaccine against the novel coronavirus (COVID-19) approved for distribution in the United States. The approval came as an emergency use authorization on December 11, 2020, after clinical trials showed the vaccine was 95% effective in preventing COVID-19.

Pfizer vaccine
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Pfizer and the German immunotherapy company BioNTech began working together on the COVID-19 vaccine in March 2020. The two companies began investigating mRNA vaccines together in 2018 to fight influenza. Clinical trials for the COVID-19 vaccine began in April 2020, and promising results from those trials led the companies to seek an emergency use authorization from the Food and Drug Administration (FDA) in November.

When Was Pfizer's Vaccine Officially Approved?

Pfizer's vaccine authorization was granted on December 11, 2020. Almost immediately after, Pfizer began shipping doses of the vaccine. Pfizer and BioNTech applied for full FDA approval in May 2021, which is still pending.

How It Works

The Pfizer/BioNTech vaccine is an mRNA vaccine, similar to the one developed by Moderna. The technology behind these vaccines has been around for about three decades and has shown promise in preventing notoriously difficult-to-prevent diseases like influenza and cancer. Unlike conventional vaccines that use inactivated or live viruses, mRNA vaccines contain no parts of the virus they fight.

An mRNA (messenger ribonucleic acid) vaccine is a single-stranded molecule that complements a strand of your DNA. These strands have a special coating that can protect mRNA from chemicals in the body that can break it down, and help it enter cells.

Rather than exposing the body to a small amount of virus to create an immune response, mRNA causes the vaccine recipient to make the protein of interest. This includes:

  • Helping the cell make part of the spiked protein that makes COVID-19 so potent
  • Teaching immune cells to recognize and fight similar spiked proteins

According to the Centers for Disease Control and Prevention (CDC), mRNA vaccines teach our cells how to make a protein—or even just a piece of a protein. This triggers an immune response.

How Was Pfizer's Vaccine Tested?

The clinical trial investigated how well two 30-microgram doses given 21 days apart worked in preventing COVID-19. More than 40,000 people participated in the clinical trial between July and November 2020—half receiving the vaccine and the other half a placebo.

How Effective Is It?

The Pfizer vaccine has performed very well in clinical trials. The effective rate of the vaccine was 52% between the first and second dose of the vaccine, 91% a week after the second dose, and 95% effective beyond that. According to the clinical trial report, out of the 10 severe COVID-19 cases noted in the study population, only one had received the vaccine, and nine had received the placebo.

An additional clinical trial of 2,260 adolescents ages 12 to 15 found the vaccine to be 100% effective in these age groups and well tolerated.

In addition to the clinical trials, a CDC study of almost 4,000 healthcare personnel, first responders, and other frontline workers under real-world conditions found the mRNA vaccines (Pfizer and Moderna) to be 90% effective at least two weeks after the second dose.

How to Get It

Pfizer/BioNTech were ready to start vaccinations just days after receiving a December 11, 2020, emergency use authorization, with the first doses given December 14. Initial supplies of the vaccine were tight, but as of May 13, 2021, almost 179 million doses of the Pfizer vaccine had been administered in the U.S. and more than 62 million people were fully vaccinated with two doses.

In addition, almost 143 million doses of the Moderna vaccine were administered and almost 49 million people were fully vaccinated with the Moderna vaccine, and more than 20 million doses of the single-dose Johnson & Johnson vaccine were given.

The CDC is leading vaccination efforts and all orders of the COVID-19 vaccines go through the agency.

State and local health departments are coordinating efforts to distribute doses of the vaccines. The vaccine is available in physician offices, health centers, community centers, and retail locations like pharmacies that administer other vaccines. In addition, FEMA (Federal Emergency Management Agency) is helping to coordinate mobile vaccination centers on buses or recreational vehicles and is offering support for some community mass vaccination sites in partnership with states.

Check your state health department and go to vaccinefinder.org to find a site near you.

On February 25, 2021, the FDA announced that the Pfizer/BioNTech vaccine could be transported and stored at regular freezer temperatures for up to two weeks. This is in addition to spending five days in standard refrigeration temperatures immediately before administration. This update may help with distribution since it offers an alternative option to the vaccine's standard cold storage requirements of around -70 degrees Celsius.

All doses purchased by the U.S. government are free to its citizens. While the vaccine itself is free, the facility or agency that offers the vaccine may request reimbursement of administration fees from public health programs and insurance plans, but no one receiving a vaccine can be charged any fees or denied access if they don't have health insurance, according to the CDC.

Who Can Get the Pfizer/BioNTech Vaccine?

Everyone 12 and older is now eligible for the Pfizer/BioNTech COVID-19 vaccine.

The vaccine was granted an emergency use authorization (EUA) by the FDA for people aged 16 and up on December 11, 2020, and it was expanded to include adolescents ages 12 to 15 on May 10, 2021. The EUA expansion followed results of a clinical trial of more than 2,000 adolescents that found the same dosage and two-dose schedule to be effective and well tolerated for this age group.

Safety information isn’t available yet or is too limited for children under age 12, pregnant women, and people who are immunocompromised. Additional data is expected in the coming months as additional trials are completed.

Pfizer announced on February 18, 2021, that a trial of the Pfizer vaccine in pregnant women, which will enroll about 4,000 people, began administering doses. The CDC says that people who are pregnant or immunocompromised can choose to get vaccinated.

On March 31, 2021, Pfizer announced it also started giving the first doses in a trial of children ages 6 months to 11 years.

On March 11, 2021, President Joe Biden announced that states would be directed to make all adults eligible for a COVID-19 vaccine by May 1.

In addition, all individuals 12 and up are now eligible and encouraged to get vaccinated, according to the CDC.

Side Effects and Adverse Events

Patients who were enrolled in the clinical trial were asked to keep a record of any local or systemic reactions after each dose of the vaccine. Mild to moderate pain at the site of injection was the most common complaint, with less than 1% of the trial group reporting severe pain. Most of the local reactions reported went away on their own in one to two days, according to the report.

Systemic effects—or reactions that affect the entire body—were more common in participants aged 16 to 55 than in participants who were older than 55. The most common effects were tiredness and headache. Less than 20% of the people who were vaccinated reported a fever after the second dose.

There were a few serious adverse reactions during the trial—one shoulder injury from the vaccination administration, inflammation of lymph nodes, cardiac arrhythmia, and limb pain or tingling. Two participants died—one from arterial disease and another from cardiac arrest, but researchers did not attribute either of these deaths to the vaccine itself. Another four people in the trial died, but they had received the placebo, not the vaccine.

Although it's rare, serious allergic reactions can occur after receiving the Pfizer vaccine. The Vaccine Adverse Event Reporting System (VAERS) reported that there were 21 cases of anaphylaxis, a life-threatening allergic reaction, after about 1.89 million first doses of the Pfizer/BioNTech vaccine (11.1 cases per million doses). Most cases occurred within 15 minutes of vaccination and no deaths were reported.

What Are Adverse Reactions?

Adverse reactions are considered to be medically significant adverse events caused by a vaccine, whereas a side effect is more common and mild reaction. Pfizer/BioNTech will continue safety monitoring for another two years on the initial trial group to watch for any additional reactions.

Funding and Development

Pfizer/BioNTech worked together on the vaccine with the help of an initial $1.95 billion in funding from the U.S. government as part of Operation Warp Speed and the Biomedical Advanced Research and Development Authority (BARDA)—a U.S. government program aimed at furthering the manufacture and distribution of vaccines to fight COVID-19.

According to Pfizer, the funds pay for the vaccine doses but were not used toward the research and development of the vaccine. The funding agreement entitled the U.S. government to the first 100 million vaccine doses the company produces, plus an option to purchase 500 million more doses after that. The government purchased an additional 200 million doses (100 million in December and 100 million in February), bringing the total to 300 million doses ordered from Pfizer at a total cost of about $6 billion.

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