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The FDA expert advisory committee (Food and Drug Administration), the United States drug regulatory agency, recommended the launch of the emergency use of the covid-19 vaccine produced by pharmaceutical companies Pfizer and BioNTech, following a virtual meeting held throughout the day. There were 13 councilor votes in favor and 4 against the authorization.
This vote, however, does not mean that the vaccine will be authorized immediately. The FDA will discuss the release of the immunizer and it can be determined in the coming days. However, today’s resolution already outlines the ways of a possible distribution of the vaccine in the US.
If the vaccine is licensed by the FDA, must be approved by the CDC (Center for Disease Prevention and Control) before the first doses are distributed in the United States. The elderly and health professionals will be the first beneficiaries, according to the Ministry of Health reported yesterday.
In a statement sent to CBS News, Pfizer CEO Albert Bourla welcomed the recommendation made by the committee, despite maintaining caution regarding the authorization that the agency has yet to issue.
“We are satisfied with the vast majority of votes, and if the FDA issues an authorization, we are ready to bring this vaccine to people in the United States in an effort to help fight this devastating pandemic,” Bourla said.
So far, only three countries have approved the use of the Pfizer vaccine: the UK, Canada and Bahrain.
In the United States, an alert will accompany the vaccine, announced Marion Gruber of the FDA: It will not be recommended for people with allergies to any of its ingredients.
Committee member Paul Offit stressed the need to reassure the tens of millions of people allergic to eggs or peanuts.
The effectiveness is 95%
The FDA had already confirmed earlier this week that the experimental vaccine for COVID-19 developed by the US pharmaceutical company was 95% effective after the second dose, according to the results of phase 3 clinical trials.
In a preliminary analysis released, the FDA noted that the companies provided adequate information to “ensure the quality and consistency of the vaccine for the authorization of the product in the United States.”
The agency also confirmed that the immunizer worked regardless of the volunteer’s age, weight or race. Pfizer BioNTech applied for authorization for emergency use of the product in the US on November 20.
More than 3,000 deaths in 24 hours
The recommendation for emergency use in the United States comes a day after the country recorded 3,034 deaths from covid-19 in the last 24 hours alone, according to data collected by the monitoring page of Johns Hopkins University.
This would be the first time that the United States has recorded more than 3,000 deaths in a single day, according to the US television networks CNN and NBC News. The daily average is 2,230 deaths since the start of the pandemic.
So far, the United States is by far the country most affected by the covid-19 pandemic in the world: there were 15,379,574 cases of the new coronavirus and 289,283 deaths from the disease. Then, in number of cases, appear India (with 9,735,850 cases and 141,360 deaths) and Brazil (with 6,728,452 cases and 178,995 deaths).
According to CNN, local authorities remain concerned about the number of COVID-19 patients admitted and the ability of hospitals to find enough rooms. On Wednesday, California broke records for cases, hospitalizations and ICU admissions. The state has only about 1,500 ICU beds available.
Top health officials in the government of US President Donald Trump drew up a schedule earlier this week that plans to distribute immunizations against the new coronavirus to up to 24 million people by mid-January.
By mid-March, “the majority of the highly susceptible population, about 100 million people,” should be vaccinated, said Moncef Slaoui, the chief scientific adviser for Operation Warp Speed, the Trump administration’s vaccine development program.
* With information from AFP
