The coronavirus vaccine manufactured by Pfizer Inc. and its German partner BioNTech SE is highly effective in preventing Covid-19 and there are no safety concerns preventing it from being granted an emergency use authorization, according to a report from staff at US Food and Drug Administration.
The report offers a first look at the US review of the vaccine ahead of a public meeting Thursday of external advisers to the agency. The FDA could approve the vaccine shortly after the meeting, with up to 6.4 million doses immediately available to kick off a massive immunization effort designed to end a pandemic that has killed more than 283,000 Americans.
The findings, published on the agency’s website on Tuesday, echoed previously released data from companies that showed the vaccine was 95% effective in preventing symptomatic Covid-19. He also said that two months of test data revealed no significant safety issues.
Pfizer applied for an emergency authorization in the US on November 20. UK regulators approved the vaccine earlier this month, and on Tuesday, the National Health Service launched an ambitious vaccination campaign that will start with tens of thousands of people over that age. of 80 in the next few days. The shot is also under review in the European Union.
The vaccine uses a technology called messenger RNA that transforms cells in the body to fight the virus. Moderna Inc. also makes an experimental Covid-19 messenger RNA-based vaccine, and FDA advisers will meet next week to consider whether it should receive an emergency clearance.
In their report, FDA staff wrote that the analyzes “showed similar efficacy point estimates across all age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with a high risk of severe Covid-19. “. Common side effects included injection site reactions, fatigue, and headache.
Pfizer has said the vaccine protected people of all ages and ethnicities, but there is not enough data on children younger than 16 to determine whether it will work in pediatric populations, FDA staff said. The data are not sufficient to make determinations on pregnant, lactating or immunosuppressed people.
Among Pfizer clinical trial participants who showed no signs of Covid-19 infection during vaccination, there were eight cases of the virus among those who received the injection and 162 among those who received a placebo, according to the report.
It is unclear if the vaccine is effective in preventing the spread of Covid-19, according to the report. The vaccine may not have worked as well in preventing cases where people did not have symptoms of the virus as it did in preventing symptomatic cases, meaning there will likely be an ongoing need for basic public health measures.
“Asymptomatic cases in combination with less mask use and social distancing could result in significant continuous transmission,” FDA staff wrote.
If the FDA approves Pfizer’s vaccine, Trump administration officials have said it could begin shipping within 24 hours. Between the Pfizer and Moderna vaccines, 40 million doses are expected to be available by the end of the year, enough for 20 million people to receive the two-shot regimen.
The Trump administration is confident the U.S. will have enough supply to eventually vaccinate everyone, a senior administration official said Monday in a call with reporters, though the FDA is expected to approve only injections made by Pfizer and Moderna. this month. The United States also has agreements to receive injections from AstraZeneca Plc, Johnson & Johnson and others.
The Centers for Disease Control and Prevention’s immunization committee recommended that healthcare workers and long-term care residents be first in line, with a total of about 23 million people. It will be up to the states to determine exactly how to distribute the vaccines.
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