More Positive News about Vaccine, US in Line to Approve Pfizer Product for Emergency-Use
NEW DELHI, Dec 8: In yet another positive in the fight against the Corona pandemic, the United States Food and Drug Administration is believed to have found the vaccine developed by its pharma giant Pfizer Inc. and its German partner BioNTech to be “highly effective in preventing Covid-19 and there are no safety concerns that would prevent it from being granted an emergency-use authorization.”
It was the same BNT162b2 vaccine developed by Pfizer and its German partner that began its global journey on Tuesday with the first shot injected to a 90-year old British citizen in the UK as part of its plan to make emergency use of the vaccine for the people above the age of 80 years.
The report emanating from Washington said the FDA could clear the shot shortly after an emergency meeting of the agency to be held on Wednesday with as many as 6.4 million doses immediately available to kick off a vast immunization effort designed to end a pandemic that has killed more than 283,000 Americans.
The findings, posted on the agency’s website on Tuesday, echoed previously disclosed data from the companies that showed the vaccine was 95% effective in preventing symptomatic Covid-19. It also said two months of trial data revealed no significant safety issues.
Pfizer requested an emergency authorization in the U.S. on November 20. Regulators in the U.K. approved the vaccine earlier this month, and on Tuesday, the National Health Service there launched an ambitious vaccination campaign that will begin with tens of thousands of people over the age of 80 in the coming days. The shot is also under review in the European Union.
In their report the FDA staff wrote that analyses “showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe Covid-19.” Common side effects included injection-site reactions, fatigue and headache.
Pfizer has said the shot protected people of all ages and ethnicities, but there was not enough data on children younger than 16 to determine whether it would work in pediatric populations, FDA staff said. Data was also insufficient to make any determinations about pregnant, lactating or immune-compromised people, the report said.
Among participants in the Pfizer clinical trial who didn’t show signs of Covid-19 infection during vaccination, there were eight virus cases among those who received the shot and 162 among those who got a placebo, according to the report.
However, despite the vaccination, if approved for emergency use, the basic public health measures like wearing of masks and maintaining social distancing would have to be followed critically as the time available was too short to determine whether the vaccine is effective at preventing Covid-19’s spread, according to the report. It’s possible the vaccine didn’t work as well at preventing cases where people didn’t have virus symptoms as it did at preventing symptomatic cases. “Asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission,” FDA staff wrote.
If Pfizer’s vaccine is cleared by the FDA, Trump administration officials have said it could begin to be distributed within 24 hours. Between Pfizer and Moderna’s vaccines, 40 million doses are expected to be available by the end of the year, enough for 20 million people to get the two-shot regimen.
The Trump administration is confident that the U.S. will have enough supply to eventually vaccinate everyone, a senior administration official said, though only the shots made by Pfizer and Moderna are expected to be cleared by the FDA this month. The U.S. also has agreements to get shots from AstraZeneca Plc, Johnson & Johnson and others.
(Manas Dasgupta)
