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(CNN) – The U.S. Food and Drug Administration (FDA) will review the emergency use authorization of the Pfizer and BioNTech vaccine candidate for covid-19 on Thursday after an advisory committee published the Tuesday an information document on that vaccine.
The document confirms that the efficacy of the COVID-19 vaccine was 95%, occurring at least seven days after the second dose, an efficacy that had previously been reported by Pfizer. The proposed dosage regimen for the vaccine is to administer two 30-microgram doses 21 days apart.
However, the document also notes that the vaccine, called BNT162b2, appears to provide “some protection” against COVID-19 after a single dose.
The document describes the efficacy of the Pfizer vaccine in the time between the first and second doses as 52.4%, but the document notes that “the efficacy observed after dose 1 and before dose 2, from a post-hoc analysis cannot support a conclusion about the efficacy of a single dose of the vaccine, because the observation time is limited by the fact that most participants received a second dose after three weeks. ‘
In other words, ‘the trial did not have a single dose arm to make an adequate comparison’.
Details of the vaccine being evaluated by the FDA
The document goes on to detail the safety profile of the vaccine as “favorable” and notes that the most common adverse reactions to the vaccine have been injection site reactions, fatigue, headache, muscle pain, chills, joint pain and fever.
Serious adverse reactions occurred in less than 4.6% of the participants, were more common after the second dose, and were generally less common in older adults compared to younger participants, according to the paper. The document adds that swollen lymph nodes may also be linked to vaccination.
Overall, “there are currently insufficient data to draw conclusions about the safety of the vaccine in subpopulations such as children under 16 years of age, pregnant and lactating people and immunosuppressed people,” according to the paper.
A total of six participants died during the trials, and “all deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.”
The document will be discussed at a meeting Thursday, where the FDA’s Advisory Committee on Vaccines and Related Biologics will provide recommendations to the FDA on whether the vaccine is effective in preventing covid-19 in people 16 years of age and older and whether Potential benefits of the vaccine outweigh the risks.
“The committee will also discuss what additional studies the vaccine manufacturer should conduct after the issuance of the emergency use authorization to collect more data on the safety and efficacy of this vaccine,” according to the document.
Aim to administer the vaccine within 96 hours of authorization
Covid-19 vaccines will be distributed to vulnerable populations within days of an emergency use authorization, an official said, as the United States struggles with a historic record of new daily cases.
“We will begin to be fired upon within 96 hours of emergency use authorization,” General Gustave Perna, Operation Warp Speed’s director of operations, said Tuesday. “That’s what I believe with all my heart.”
Pfizer and Moderna have vaccine candidates awaiting authorization for emergency use, and FDA has confirmed Pfizer’s safety and efficacy ahead of Thursday’s approval meeting. Advance approval comes as the U.S. experiences spikes in coronavirus cases, hospitalizations and deaths.
The United States has registered an average of 206,152 new cases per day over the past seven days, the highest number of cases from the pandemic so far. And on Tuesday, 104-600 people were hospitalized with the virus, according to The COVID Tracking Project, a record that has been set and broken time and again in recent weeks. In total, more than 286,000 people have died from the virus and more than 15.1 million have been infected, according to data from Johns Hopkins University.
The general public will likely have to continue to grapple with the Christmas season peaks until vaccines are widely available in 2021. But officials are racing to distribute vaccines in the coming days for priority populations: the elderly and working people. Of the health.
While it will be a “Herculean task,” Perna said she is confident that, with CDC planning and partner collaboration, “we will be able to deliver this vaccine very efficiently, but more importantly, effectively.” .
With information from Madeline Holcombe and Jacqueline Howard
