Moderna is seeking FDA clearance today for its Covid-19 vaccine

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The company will ask the FDA to review an expanded data set showing the vaccine is 94.1% effective in preventing Covid-19 and 100% effective in preventing severe cases of the disease.

“It’s striking,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “This is amazing data. ”

Moderna’s chief medical officer said he became emotional when he saw the data on Saturday night.

“It was the first time that I allowed myself to cry,” said Dr Tal Zaks. “We have every hope of changing the course of this pandemic. ”

Moderna will become the second company to seek approval from the FDA for emergency use of a coronavirus vaccine. Pfizer applied on Nov. 20 with data showing equally high effectiveness.

The FDA will meet with its advisory committee in December to review the applications from Pfizer and Moderna.

The first vaccinations in the United States should take place “towards the end of December,” according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

New data from Moderna

Moderna published updated efficacy data for its Phase 3 clinical trial on Monday.

Beginning in July, Moderna administered its vaccine or a placebo – a dose of saline that does nothing – to some 30,000 people in the United States. With high rates of coronavirus across the country over the next few months, many of these study subjects developed Covid-19.

But there was a big difference between the group that received the vaccine and the group that received the placebo.

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Of the approximately 15,000 people who received the vaccine, 11 developed Covid-19.

Of the approximately 15,000 people who received the placebo, 185 developed Covid-19.

This equates to an efficacy of 94.1% for Moderna’s vaccine.

None of the 11 people who received the vaccine became seriously ill, but 30 of the 185 people who received the placebo became seriously ill and one of them died.

The vaccine had similar effectiveness rates for the elderly and for people belonging to racial minority groups, Zaks said.

In Pfizer’s Phase 3 clinical trial, the vaccine was found to be 95% effective, and a study participant who received the vaccine developed a severe case of Covid-19.

Although the two vaccines are not identical, Pfizer and Moderna both use messenger RNA to illicit an immune response in the human body. The vaccines are given in two doses a few weeks apart and may cause side effects, such as fever or body aches for a few days.

Next steps

The FDA is scheduled to meet with its Vaccines and Related Biologics Advisory Committee on December 10 to review Pfizer’s application and on December 17 to review Moderna’s application.

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Offit, who is a member of that panel, said it would be important to look and see why some people still had Covid-19 even after being vaccinated.

“Were they more likely to be older? Were they more likely to be African American or obese or to have underlying medical conditions like diabetes? Said Offit, a vaccine expert at the University of Pennsylvania.

If the FDA grants emergency use clearance for the vaccine – and it is expected to do so – within a day or two, an advisory committee of the US Centers for Disease Control and Prevention – United will make a recommendation on who should get the shots first. This group is likely to include healthcare workers and residents of nursing homes.

Once the CDC issues these recommendations, gunfire can enter the arms.

Zaks said as the pandemic raged, he was eager to see vaccines in action.

By the end of 2020, Moderna expects to have around 20 million doses of its vaccine available in the United States, and it is on track to manufacture 500 million to 1 billion doses worldwide next year. , according to the company’s press release on Monday.

“The magnitude of this achievement and the implications of what it means for what lies ahead in the context of what’s going on around us is – it’s just emotionally overwhelming,” Zaks said.

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