FDA granted full approval to Pfizer’s vaccine

Approval could offer security to millions of people

So far, more than 92 million people in the country have been fully vaccinated with Pfizer’s two-dose regimen, according to federal data; that is, around 54% of the population is fully vaccinated. And health experts hope that official approval will propel millions more to do the same, especially as COVID-19 cases, hospitalizations and deaths caused by the highly contagious delta variant are on the rise across the country. .

A Kaiser Family Foundation survey found that about 30% of unvaccinated people said they would be more likely to get vaccinated if fully approved; many of those who objected cited safety concerns without official FDA endorsement. If FDA approval motivates this population to receive the vaccine, it could help turn the tide of the pandemic, says Rupali Limaye, director of Behavioral and Implementation Sciences at the International Vaccine Access Center at the School of Public Health. Johns Hopkins Bloomberg.

“If we take a more conservative estimate – if we can vaccinate 10% more of the eligible population against COVID – that’s going to make a big difference from community transmission,” says Limaye. According to the CDC, nearly 90% of the country’s counties are experiencing high levels of virus transmission.

The approval process for Pfizer’s vaccine, which will now be marketed under the name Comirnaty, was based on safety and efficacy data from a large population of clinical trials. More than half of the trial participants were monitored for safety for at least four months after the second dose; Some 12,000 participants have been followed for at least six months.

Overall, the vaccine was found to be 91% effective in preventing COVID-19 in the population studied, and the most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. Safety monitoring will continue, the FDA says, including for the risk of myocarditis and pericarditis after administration of the vaccine.

In addition to evaluating “hundreds of thousands of pages” of data, FDA officials also “conducted a detailed assessment of the manufacturing processes, including inspections of manufacturing facilities,” it said in a statement, as part of the process of approval, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“The public and the medical community can rest assured that while we approved this vaccine quickly, it fully conformed to our existing high standards for vaccines in the United States,” he added.

Pfizer’s approval could also spur vaccination orders at more companies and organizations across the country, potentially boosting vaccination. So far, about 51% of the total population of the country is fully vaccinated.



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