Wednesday, October 27

Experts Recommend the Emergency Authorization of Moderna’s Vaccine in the US | Society


Stock photo of Moderna's vaccine.
Stock photo of Moderna’s vaccine.JOEL SAGET / AFP

Moderna’s coronavirus vaccine has received the green light this Thursday from a panel of health experts from the United States Food and Drug Administration (FDA) for this agency to approve it on an emergency basis. If authorized, Moderna’s vaccine would follow the path initiated by Pfizer to try to contain a pandemic that in the United States has already claimed more than 310,000 lives. The FDA plans to authorize the vaccine this Friday, according to sources cited by US media familiar with the negotiations.

The committee, made up of immunologists, epidemiologists and experts in infectious diseases, met for about eight hours studying issues such as the safety of the vaccine or an equitable distribution of the same. The vote to recommend its approval was 20 in favor and one abstention.

Last Tuesday, the FDA noted in a preliminary report that Moderna’s vaccine had “a favorable safety profile” and that no “specific safety problems that would prevent the issuance of an emergency authorization had been identified.” If approved, the way will be paved for six million doses to begin being distributed to 3,285 locations in the first week after approval.

Last Friday, the FDA gave the go-ahead to the emergency use of the Pfizer and BioNTech vaccine, and since Monday hospitals began receiving the first 2.9 million doses and vaccinations began.

Formal authorization from the FDA drastically shortens the usual timeframes for drug approval. In the case of Pfizer, the agency did not find any complications or threats to patient safety in its review of the phase 3 clinical trial conducted by the multinational on 44,000 people.

While this week the country has registered a sad new record with 3,656 deaths in a single day, on Wednesday, the outgoing president, Donald Trump, remains silent. However, the day before the vaccinations began, the Republican defended that the vaccine, the “greatest and fastest medical miracle in contemporary history,” should be attributed to his mandate and not that of President-elect Joe Biden, who will assume the January 20.

Among all participants in Moderna’s studies, the reported efficacy was 94.5%. But what was striking was the figure among participants aged 65 and over: 100%. That is, 0 infections among the 3,527 volunteers in this group, while among people between 18 and 65 years, it was five positive among 10,407 people. In addition, among the reported cases, there was no serious picture of covid-19.

The assistant secretary of the US Department of Health and Human Services, Brett Giroir, declared that today “the end of the pandemic is in sight,” reports the EFE agency. “With two companies making the vaccine, it will be an addition to the supply that is slowly being developed,” he said in a call with reporters.

Information about the coronavirus

– Here you can follow the last hour on the evolution of the pandemic

– Restrictions search engine: What can I do in my municipality?

– This is how the coronavirus curve evolves in the world

– Download the tracking application for Spain

– Guide to action against the disease


elpais.com

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