Saturday 18 September 2021

United States Grants Full Approval for Pfizer-BioNTech’s Covid-19 Vaccine

The vaccine, which will now be marketed under the Comirnaty brand, is the first to receive full approval

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RICO’s COVID DIGEST – The United States Food and Drug Administration (FDA), this Monday, August 23, granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older.

The U.S. drug regulator on Monday granted full approval to the Pfizer COVID-19 vaccine that had earned emergency-use authorization in December, making it the first to secure such Food and Drug Administration (FDA) validation as health authorities struggle to win over vaccine skeptics

This is the first to move beyond emergency use status in the United States, which is expected to set off a cascade of vaccine requirements by hospitals, colleges, corporations, and other organizations.

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The approval comes as the fight against the pandemic has intensified in the U.S. again.

If you’re not vaccinated yet, now is the time,” U.S. President Joe Biden said on Twitter, as his administration hopes the approval will motivate at least some of the roughly 85 million unvaccinated who are eligible for shots to get them.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the F.D.A. approval of a vaccine may now instill additional confidence to get vaccinated,” Dr. Janet Woodcock, the acting F.D.A. commissioner, said in a statement.

Pfizer said it presented the F.D.A. with data from 44,000 clinical trial participants in the United States, the European Union, Turkey, South Africa, and South America. The company said the data showed the vaccine was 91% effective in preventing infection — a slight drop from the 95% efficacy rate in December.

Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected.

The vaccine will continue to be authorized for emergency use for children ages 12 to 15 while Pfizer collects the necessary data required for full approval.

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So far, in the U.S., more than 92 million people — 54% of those fully inoculated — have gotten Pfizer shots. Most of the rest received Moderna’s vaccine.

Hit for the anti-vaccines

“This has eliminated one of the arguments of the anti-vaccine movement, which has falsely claimed that it was an ‘experimental vaccine,'” said Amesh Adalja of the Johns Hopkins University Center for Health Security.

“Hopefully now the people who said they were waiting for full approval to get vaccinated will do so,” she added.

In a recent survey by the Kaiser Family Foundation, 30% of adults said full approval would make them more likely to get vaccinated.

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This measure comes at a time when the delta variant ravages the country, causing new cases and hospitalizations that are approaching the levels last seen during the winter wave.

The worst affected regions are the southern states of Florida, Alabama, Mississippi and Louisiana.

Some 628,000 people have died from coronavirus in the United States, the country hardest hit by the pandemic in absolute terms.

In Costa Rica

In Costa Rica, the Ministry of Health has yet to comment on the development.

According to the data provided ty the Caja Costarricense de Seguro Social (CCSS) to Ausut 16, it applied 3,848,155 doses – 2,948,584 (57.11%) with the first dose and 899,571 (17.42%) – of the eligible population (4,274,344) 12 years and older, representing 83% of the total population of 5,163,021) of Costa Rica.

New figures are expected by the CCSS typically announced during Mondays. Click here for the CCSS Vaccination statistics.

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Q Costa Rica
Reports by QCR staff

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