US officials have said that between the two vaccines, Pfizer and Moderna, there will be enough doses to immunize 20 million Americans by the end of December 2020
The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Moderna’s coronavirus vaccine on December 18. The vaccine can be given to Americans aged 18 years and older. This is the second vaccine that has been given the green light in the country’s fight against the Covid-19 pandemic after the agency okayed Pfizer-BioNTech’s coronavirus vaccine on December 11. The first shots of the Pfizer vaccine were given to Americans on December 14. Inoculations with Moderna’s vaccine could begin on Monday, December 21.
The FDA determined that the Moderna vaccine has met the statutory criteria for issuance of EUA. The totality of the available data “provides clear evidence” that the Moderna coronavirus vaccine may be effective in preventing the illness, noted the agency. The data also show that the known and potential benefits outweigh the known and potential risks — supporting the company’s request for the vaccine’s use in people 18 years of age and older. The FDA assured the public and the medical community that in making this decision, it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the US each day,” said FDA Commissioner Dr Stephen M Hahn in a statement. He added, “Through the FDA’s open and transparent scientific review process, two Covid-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA.”
Stéphane Bancel, chief executive officer of Moderna, said in a statement: “I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna Covid-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants.”
On November 30, Moderna submitted an emergency use authorization (EUA) request to the FDA for its vaccine candidate based on phase 3 results which showed that vaccine efficacy against Covid-19 was 94.1%. An independent analysis by the FDA concurred with the findings.
On December 17, an advisory panel of the FDA recommended the emergency use of Moderna’s Covid-19 vaccine. The question that members had to. Brinkwire Brief News.