Coronavirus vaccine: United States to approve use of Pfizer-Biontech vaccine

The FDA has yet to approve the vaccine, but has released a document declaring the trial data “in line” with the recommendations in the emergency use guidelines.

The UK regulatory body approved the vaccine last week.

Last week, Dr Anthony Fauci, the leading infectious disease specialist in the United States, apologized for comments that seemed critical of the UK’s vaccine approval process.

Fauchi told the BBC at the time that the vaccine approval procedures in the United States “are taking longer than in Britain. This is only the case. I didn’t want to point out any loopholes.” .

Detailed data, released by the Food and Drug Administration, shows the vaccine to be 95% effective, which is in line with original data released by Pfizer.

Although two doses were needed to ensure complete protection, the first dose prevented 89% of severe cases.

The vaccine gave similar levels of protection to people who had previously contracted a Covid-19 infection.

The document, released Thursday ahead of the Food and Drug Administration meeting, said the most common side effects experienced by people who received the vaccine were pain, redness, or swelling at the injection site (usually the arm ).

This was followed by short-term fatigue, headaches, and muscle pain.

But apart from these mild effects, there was no significant difference in health conditions between the vaccinated group and the control group during the study period.

Pregnant women under 16 were not included in the study, so the vaccine will not yet be approved for these groups.

Regulators in the United States and Britain have slightly different approval procedures for new vaccines.

They both do an internal assessment and consult with an advisory committee, but the FDA is considering preliminary numbers during trials.

If the vaccine is cleared for use in the United States, surveillance will continue to ensure its safety.