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WASHINGTON (BLOOMBERG) – Moderna’s vaccine is safe and effective in preventing Covid-19, US regulators said, paving the way for a second injection to quickly obtain emergency clearance and contribute to the extensive effort. immunization of the country.
Food and Drug Administration staff said in a report on Tuesday (December 15) that the experimental vaccine is 94.1 percent effective in preventing symptomatic Covid-19, confirming previous results published by the company.
The report was published online ahead of a meeting Thursday of the agency’s advisers, who will vote on whether to recommend authorization before a final FDA decision.
The agency does not have to follow the advice of independent vaccine experts, although it often agrees with its advisory panels. Last week, the FDA authorized a similar vaccine from Pfizer and BioNTech after an advisory panel voted 17-4, with one abstention, to support its authorization.
The FDA looked at Moderna’s clinical trial data much more deeply than the company’s previously published figures.
In particular, the agency was able to review the vaccine’s effectiveness in a wide range of racial, ethnic, and age groups, and look at evidence of how well the vaccine worked for people with pre-existing medical conditions that make them more vulnerable to the disease. severe covidity. 19.
The agency found that the vaccine was equally effective in all racial and ethnic groups and in those with underlying medical conditions.
It was 86.4% effective in people 65 and older, according to the report, and 95.6% effective in people 18 to 65 years old.
Both the Moderna vaccine and the Pfizer vaccine are based on messenger RNA technology that has not previously been used in inoculations. Also, both are two-dose vaccines, meaning that once people receive an initial injection, they will need to return to their care providers weeks later for an additional injection.
Between Pfizer and Moderna, Operation Warp Speed officials have said that 20 million people in the United States are expected to get their first injections by the end of the year.
Covid-19 cases and hospitalizations are increasing across the country, increasing pressure to control the pathogen.
While health officials are hopeful that the immunization push will begin to curb a pandemic that has killed more than 300,000 Americans, it is not yet known what effect vaccines have on transmitting the disease.
The Pfizer and BioNTech vaccine was first approved in Britain, where there were some reports of serious reactions that led regulators to discourage anyone with a history of major allergies from getting vaccinated.
The FDA did not take that step, but told the facilities where the vaccine would be administered to have medications on hand to treat possible allergic reactions, including a severe form called anaphylaxis.
Moderna’s vaccine is not yet approved in any other country and has not yet been used in anyone outside of a clinical trial.
Once the U.S. grants clearance, advisers from the Centers for Disease Control and Prevention should come together, as they did last week with the Pfizer vaccine, to green-light Moderna’s vaccine and provide specific recommendations for its use and monitoring.
Moderna’s vaccine will be distributed to sites across the country where healthcare workers and residents of long-term care facilities, such as nursing homes, are expected to receive the first doses.
The first vaccines from Pfizer and BioNTech were shipped to more than 600 sites across the country. Injection must be kept extremely cold and requires special freezers for transport, while Moderna can be kept in more traditional cold storage.
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