The United States has authorized the third dose of Pfizer vaccine for people over 65 and workers with high exposure to the virus. It is the decision of the Food and Drug Administration (Fda), the federal agency that regulates the approval of new drugs. It can be administered from the sixth month after the booster. This is a potential audience of 22 million people.
In Europe
Ema, the European medicines agency, will also decide by October on the guidelines to be adopted for the third dose. Meanwhile, many EU states – including Italy – have decided to proceed independently. “EMA’s decision on the third dose of Pfizer is expected in early October,” a source told Reuters. The drug authority began evaluating Pfizer’s booster shot data on September 6. Moderna will also present its evidence to the EMA by the end of the month this month.
The ECDC (European Center for Disease Control) had expressed concerns about the urgency of a third dose. Opinion then republished by Ema. The priority, according to the agency, was not to divert further doses to countries with a high percentage of vaccinated, giving time to the most backward nations to close the gap. However, he stressed that a second booster for immunosuppressed and frail people might be necessary.
In the United States
“Today’s decision – explains Janet Woodcock, interim head of the Food and Drug Administration – shows that the science and available data continue to guide the decision-making process of the FDA for Covid-19 vaccines during this pandemic”.
The baton now passes to the CDC, the center for disease control, which could expand the basin of vaccinators. For example, by including the obese among the high-risk Covid subjects, thus involving over 42% of the US population. The agency will decide which workplaces are most exposed to the infection. The change to the emergency use authorization of the vaccine will help protect health care workers, teachers and care staff, workers in contact with the public, the homeless and prison workers.
Pfizer asked the FDA to approve the third dose for all over 16. But the panel of experts voted against, arguing that the benefit-risk data for young people differed from adults. Especially in the case of males at risk of myocarditis. “The authorization of the third dose is a milestone in the fight against the coronavirus,” said Pfizer CEO Albert Bourla. The United States approved the emergency use of the “booster” for the frail and immunosuppressed as early as August, in the wake of countries like Israel. More than two million Americans who have already received it. The decision comes after the final approval of Pfizer’s vaccine last month, which had previously been administered in an emergency. The United States has been experiencing an increase in infections in recent weeks. A rise that is complicating the management of the epidemic at the federal level, together with the slowdown in vaccinations in many states of rural America.