FDA approves the first COVID-19 vaccine in the United States and begins distribution

The original version of this article was published in our sister publication Contagion.

On Friday night, the US Food and Drug Administration (FDA) granted an Emergency Use Permit (EUA) as the first vaccine for BNT162b2. Coronavirus Prevention 2019 (COVID-19) In the United States.

The approvals granted to Pfizer and BioNTech have begun a new phase of clinical response to the global epidemic that has afflicted more than 15 million Americans and killed another 300,000 in just 10 months.

This groundbreaking decision also interrupted unprecedented efforts among pharmaceutical collaborators, clinicians, and federal agencies. The conception, creation, evaluation, and regulation of messenger RNA (mRNA) vaccines against deadly and highly contagious viruses. This is also only 10 months.

As one virologist said Contagion® This week, the EUA could mark the “beginning of the end” of the COVID-19 pandemic.

Approval

The FDA and Pfizer have announced that BNT162b2 has been granted an emergency permit to prevent COVID-19 in people over the age of 16 in the United States.

The EUA was granted based on data from the ongoing real-world multinational Phase 2/3 assessment of mRNA vaccines and placebo in designated age groups. data, Shared by FDA Participants who were submitted with the EUA application in November prior to the BNT162b2 Vaccine and Related Biologics Advisory Board (VRBPAC) meeting on Thursday and received treatment without previous SARS-CoV-2 infection 7 days ago. A second dose of the vaccine showed 95% overall vaccine efficacy between.

At the time of EUA submission, Pfizer reported 8 COVID-19 cases out of 18,198 eligible participants who received the vaccine, compared to 162 who received placebo.

FDA approval was also supported by expert VRBPAC panel approval. A long series of public sessions We scrutinized the clinical efficacy and safety of BNT162b2 and voted 17-4 in a single abstention to support the benefits-risk profile in the prevention of COVID-19.

In a peer-reviewed article of test data published in New England Journal of Medicine On Thursday, researchers emphasized that the findings are more important than the overall performance of the vaccine.

“The results show that COVID-19 can be prevented by vaccination, provide a proof of concept that RNA-based vaccines are a promising new approach to protect humans from infectious diseases, and can develop RNA-based vaccines. It shows speed. Sufficient resource investment. “

As they pointed out, BNT162b2 was launched on January 10th of this year when the Chinese government released the SARS-CoV-2 sequence.

“This rigorous demonstration of safety and efficacy within 11 months is because RNA-based vaccines, which require only viral genetic sequence information to begin development, fight the outbreak of pandemics and other infectious diseases. It really shows that it is a major new tool for. “

vaccine

BNT162b2 is a nucleoside-modified mRNA vaccine that encodes SARS-CoV-2 full-length peplomer glycoprotein. Of the four COVID-19 vaccines initially evaluated by Pfizer, a double dose regimen of 30 mcg was designated for further evaluation in late July. Shortly before that designation, the FDA granted the candidate a fast track designation.

The mRNA vaccine platform is new in regulated use, but has been investigated for nearly 20 years.As William Schaffner, MD, professor of preventive medicine at Vanderbilt University Medical Center, said ContagionPrior to rapid progression of the COVID-19 mRNA vaccine, which contains BNT162b2 and Moderna mRNA-1273, a 10-15 year worth of clinical evaluation will be performed.

As Schaffner explains in the video below, the double-dose vaccine acts as a delivery of “genetic instructions” that lead to the generation of an antibody response to the peplomer glycoprotein. Schaffner emphasized that developed immunity did not consist of a “slow” second dose, but the first and second vaccinations were given at 21-day intervals in clinical evaluation.

“It takes about a couple of weeks for the immune system to be ready, and then it’s ready,” he explained.

According to Pfizer’s available Phase 2/3 data, the requested adverse events 7 days after vaccination were fairly common among study participants. Common requested local reactions included pain, swelling, and redness at the injection site. Common requested systemic events included fever, malaise, headache, chills, vomiting, diarrhea, and new or worsened muscular joint pain.

Schaffner emphasized that it is not possible to obtain COVID-19 from the vaccine in response to symptoms that may give the patient a pause.

Distribution plan

Pfizer currently plans to produce 50 million vaccines worldwide by the end of this year and up to 1.3 billion vaccines by the end of 2021. The company also has a goal for the US Operations Warp Speed ​​Program to administer 300 million COVID-19 vaccines with the US Department of Health and Human Services (DHHS) by next year.

Under the agreement, the federal government will receive a dose of 100 million BNT162b2 with EUA approval, cost $ 1.95 billion, and have the option of obtaining an additional 500 million doses.

Last week, the 15-member Advisory Committee on Immunization and Implementation (ACIP) prioritized front-line healthcare providers and caregivers, the latter being considered to be at greatest risk of COVID-19 severity. I voted for 13-1 to do. Imminent vaccine.

The unique properties of BNT162b2 and the current need for rapid dose distribution at the time of maximum occurrence of new US COVID-19 cases poses unique challenges to Pfizer. The company announced that it will ship the vaccine in a temperature-controlled thermal package that can maintain temperatures of -70 degrees Celsius through dry ice.

As some experts explain Contagion, Proper storage and administration of such vaccines can make a difference in their effectiveness.

What’s next

The approval of BNT162b2 allows people in the United States to receive the vaccine as directed, but continues to evaluate and monitor its EUA allowance.

As Dr. Angelara Smoothen of the Georgetown Global Health Sciences and Security Center said Contagion, Currently, little or no understanding of how the COVID-19 vaccine investigated affects viral load and risk of community infection. This result can only be observed in populations that have been vaccinated for longer periods of time.

This means continuing the COVID-19 spread mitigation strategy, regardless of your own vaccination status.

“Wear a mask, keep a social distance, and ventilate, whether you are the first vaccinated group or the vaccine becomes widely available beyond the first group you are trying to vaccinate. We need to think about and avoid large-scale vaccines. There will be a rally for a while, “Rasmussen said.

Rasmussen further emphasized the attention of the American people in the future. Currently available safety data for BNT162b2 do guarantee EUA indications, but vaccines are in the larger population.

Given these uncertainties surrounding the vaccine, and the hesitation or opposite proportion of the vaccine in the general population, Rasmussen will regain normality, that is, manage COVID-19 infection without obligation to keep a social distance in 2021. I expect it to come in the second half.

In the meantime, there will be more COVID-19 vaccines considered for emergency permits. Moderna’s mRNA-1273 vaccine will undergo its own VRBPAC hearing on Thursday, December 17, after reporting similar efficacy and safety profiles to Pfizer’s known vaccine.

In 2020, the same year that the COVID-19 pandemic was heavily burdened, the availability of multiple vaccines to the general public in the United States could be very successful. Experts now emphasize that people need to seriously consider these options when vaccination opportunities come.

“Look at this data, listen to science and doctors, and listen to people explaining what the data really says,” Rasmussen advised. “So far, according to the data, these vaccines are safe and very effective, and you should consider taking them when they become available.”