US FDA advisory panel recommends emergency approval of Pfizer Covid vaccine

at 12:26 pm

New Delhi (NVI): An advisory panel to the US Food and Drug Administration (FDA) has recommended the emergency approval of a Covid-19 vaccine developed by Pfizer and BioNTech.

The recommendation is expected to signal that the first approval of a Covid-19 vaccine for use in the US is imminent. That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally.

Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation.

In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and older.

The independent review by non-government experts in vaccine development, infectious diseases and medical statistics was considered critical to boosting Americans’ confidence in the safety of the shot, which was developed at breakneck speed less than a year after the virus was identified.

Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December.

But initial supplies will be limited and reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line until the shots become widely available on demand, something that will probably not happen until the spring.

Experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can be held in check. That means it could be several months before things start get back to normal and Americans can put away their masks.

Meanwhile, FDA next week will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University

-CHK