FDA Approves Third Dose Of Pfizer Against COVID-19 In Seniors And At Risk

La FDA aprobó de manera oficial la tercera dosis contra el COVID-19 en personas mayores de 65 años y población en riesgo.


The FDA officially approved the third dose against COVID-19 in people over 65 years of age and population at risk.

Photo: Robyn Beck / Getty Images

The Food and Drug Administration (FDA) officially approved this Wednesday the third dose of the Pfizer-BionTech vaccine for Americans 65 and older and at-risk seniors. Despite an additional injection being approved, President Joe Biden’s plans were far more ambitious.

Today’s decision demonstrates that currently available science and data continue to guide FDA decision-making for COVID-19 vaccines during this pandemic.“Said in a statement the director of the organization, Janet Woodcock.

This FDA decision comes in the middle of a debate in the United States about the need to administer a third dose to its entire population and worldwide on the suitability of doing so while other countries still do not have enough vaccines.

For its part, the Centers for Disease Control and Prevention (CDC) opened just this Wednesday a discussion that will last two days and in it they will discuss the additional dose of the vaccines, to whom they should be administered and when they will be applied.

Usually FDA Approves Measure Before CDC Brings Its Own Experts Together, which did not happen this Wednesday.

Setback in Biden’s plans

The Biden administration thought the unknowns in a third dose were straightforward, but the reality is that the science behind these injections is much broader than it appears.

Just last week a FDA advisory committee overwhelmingly rejected (16-2) the proposal to vaccinate the elderly population in the United States for the third time. However, it was approved for the elderly and at risk of seriously suffering from COVID-19.

According to the FDA statement, people qualified to receive the additional inoculation will do so six months after the second dose, and not at eight as Biden had estimated in August.

“We have been preparing for weeks to administer booster shots to eligible Americans and we are ready to do so following the final recommendation from the CDC later this week,” said Jen Psaki, a White House spokeswoman.

The data presented by Pfizer and the government of Israel for the third dose in older people is quite robust. However, they falter when the age of the person decreases, which makes experts think that so far not the entire population of legal age deserves to be vaccinated again.

The FDA also referred to the people who were vaccinated with Moderna or Johnson & Johnson and that a date after six months will be chosen, since they do not recommend combining those of Pfizer doses with those of other pharmaceutical companies regardless of its percentage of effectiveness.

The Pfizer dosage is the only one that is fully FDA approved, while the others have only emergency authorization.

In a statement, Pfizer CEO Albert Bourla said that “vaccine boosters have an important role to play in addressing the continuing threat of this disease” and called the FDA’s decision a “crucial milestone” in the fight against COVID-19.

With information from The Associated Press.

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