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Pfizer’s COVID-19 vaccine appears to be safe and effective enough for limited approval, based on the findings of a review by federal regulators published Tuesday.
The United States Food and Drug Administration (FDA) released an informational document ahead of the Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10.
New York-based Pfizer applied for an emergency use authorization (USA) on November 20 for its vaccine, developed with BioNTech, as reported by Medscape Medical News. The companies want FDA clearance for use of the vaccine in people over 16 years of age, with a proposed regimen of two doses administered 21 days apart.
In their report, FDA staff said that research data involving some 38,000 participants “suggests a favorable safety profile, with no specific safety concerns identified that would prevent the issuance of an EUA” for the Pfizer vaccine.
The staff noted “a numerical imbalance of four cases of Bell’s palsy” among the people who received the vaccine compared to no cases in the placebo group. The “four cases in the vaccine group do not represent a higher than expected frequency in the general population,” FDA staff said.
“Otherwise, there were no notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurological, neuro-inflammatory, and thrombotic events) suggesting a causal relationship with the BNT162b2 vaccine,” according to Pfizer / BioNTech it’s called a vaccine, FDA staff wrote.
The FDA will consider the recommendations of the advisory committee when deciding whether or not to approve the Pfizer vaccine, although the agency is not bound by them. The FDA is expected to act quickly on this request.
Efficacy threshold
The data collected so far on the vaccine also indicates that it will meet the FDA threshold of effectiveness. The efficacy of a two-dose administration of the vaccine has been set at 95.0%, with eight cases of COVID-19 in the vaccine group and 162 cases of COVID-19 in the placebo group. FDA staff said the 95% credible range for the vaccine’s efficacy was 90.3% to 97.6%.
Previous press releases from Pfizer had set an expectation that the vaccine would meet the FDA’s target of at least 50% effectiveness. The FDA listed this objective in a June guidance document, which allowed for a lower limit of the 30% confidence interval.
Speaking as a guest on Dec. 4 at a meeting of the National Vaccine Advisory Committee, the acting chairman of the FDA’s Dec. 10 VRBPAC meeting noted that the data on the Pfizer vaccine appeared to have significantly exceeded the agency’s targets.
“So we can hope that unless there are surprises, there won’t be a problem in terms of efficacy,” said Arnold Monto, MD, interim president of VRBPAC and a professor at the University of Michigan School of Public Health in Ann Arbor.
VRBPAC’s task in considering the Pfizer vaccine involves balancing the need for a rigorous review given to any FDA application, while also taking into “consideration the issue of extraordinary need due to the pandemic,” Monto said.
As of December 8, more than 1.5 million deaths have been attributed to the pandemic worldwide, including more than 270,000 in the United States, according to the World Health Organization (WHO).
Protection against disease?
More than a dozen COVID vaccine products have reached advanced levels of development, including those developed in Russia and China, according to the WHO.
The two main candidates for the US market are the Pfizer / BioNTech vaccine and a similar vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases. The FDA VRBPAC will review a US application for the Moderna vaccine on December 17.
Both the Moderna and Pfizer vaccines are based on a new approach, which uses messenger RNA to carry genetic instructions to try to make human cells produce specific proteins.
Pfizer vaccine is supplied frozen (-80 ° C to -60 ° C [-112°F to -76°F]), multi-dose vial (5 doses), said FDA staff. But Moderna has said that its vaccine can remain stable at standard refrigerator temperatures of 2 ° C to 8 ° C (36 ° to 46 ° F), “the temperature of a standard household or medical refrigerator,” for 30 days.
Also among the companies with COVID vaccines in advanced testing is Johnson & Johnson, which has highlighted the possibility of a single-dose regimen for its product.
Fierce competition between drug manufacturers can be beneficial to patients. Doctors may need to spend time next year weighing the pros and cons of competing vaccines to prevent SARS-CoV-2 infection, a threat identified only in early 2020, Robert H. Hopkins Jr, MD, chair of the U.S. Department of Health and Human Services National Vaccine Services Advisory Committee, said Medscape Medical News In an interview.
“Our challenge may result in the next nine months or so deciding which one is best for which group,” said Hopkins, who is also a professor of Medical Sciences at the University of Arkansas at Little Rock. “And it may not be the same answer for all groups.”
The rapid pace of development of COVID vaccines adds new challenges to the FDA review. In the informational document, FDA staff emphasized the conditional nature of a US approval.
Even with an EUA, a COVID vaccine would continue to be considered an “unapproved” product until the company that developed it successfully completes FDA procedures for a biological product license application (BLA).
To obtain a BLA, a vaccine developer will need to provide “a greater assurance of safety based on a greater number of vaccine recipients who have been followed for a longer period of time, and additional information on efficacy that addresses, among other questions. , the potential for protection to decline over time, “FDA staff said.
FDA staff also noted that a US approval for the Pfizer vaccine would not “in and of itself be a reason to immediately stop blind follow-up in an ongoing clinical trial or a reason to offer the vaccine to all placebo recipients.” .
“To minimize the risk that the use of a non-EUA approved vaccine will interfere with the long-term evaluation of safety and efficacy in ongoing trials, it is critical to continue collecting data on the vaccine even after it is available. under the EUA, “the FDA staff said.
FDA staff also urged not to make assumptions about the potential efficacy of a one-dose regimen of Pfizer vaccine based on available data. There hasn’t yet been the kind of examination of a single-dose regimen to make a proper comparison with the two-dose regimen, the FDA said.
“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, “wrote the FDA staff.
However, from the results seen to date, there may be a clue that the Pfizer vaccine may help prevent severe cases of COVID-19, FDA staff admitted. There were 10 study participants who had severe COVID-19 illness after the first dose: one who received the vaccine and nine who received placebo.
“The total number of severe cases is small, which limits the overall conclusions that can be drawn; however, the case division suggests protection against the severe disease COVID-19,” said FDA staff.
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