Moderna Covid-19 vaccine gets emergency use from FDA advisers

A Food and Drug Administration advisory committee on Thursday voted 20-0, with one abstention, to recommend the Moderna Covid-19 vaccine for emergency use authorization for people aged 18 and over, determining that The benefits of the vaccine outweigh the risks. This makes the Moderna Covid-19 vaccine the second to receive the green light from the committee.

The FDA is expected to accept the recommendation of the Advisory Committee on Vaccines and Related Biologics within days, by which time the vaccine, which is nearly 95% effective, can begin distribution to health workers and clinicians. high risk populations.

“We are in an unprecedented crisis, and I didn’t think an EUA was the way to go, but since the train left the station, I appreciate that Moderna has given us a very transparent and in-depth study which, even from the start, seemed very well organized, ”said A. Oveta Fuller, associate professor of microbiology at the University of Michigan and temporary voting member of the committee, explaining her favorable vote.

The vote for the Moderna vaccine comes a week after similar approval for the Covid-19 vaccine developed by Pfizer and BioNTech, which also uses an mRNA platform to generate immunity and is administered in two doses spaced several weeks apart. This vaccine began this week in the United States in all 50 states.

Operation Warp Speed, the Department of Health and Human Services’ $ 10 billion program to accelerate the development of the Covid-19 vaccine, predicts that 12.5 million doses of the Moderna vaccine will be ready for distribution before the end of the month. Health and Human Services Secretary Alex Azar told a press conference on Wednesday that the program had purchased 100 million doses of the Moderna vaccine and 100 million doses of the Pfizer / BioNTech vaccine to be delivered by here the end of March.

Unlike Pfizer, Moderna has received direct support from the U.S. government for its research and development, totaling $ 4.1 billion for clinical trials and manufacturing. Moderna’s vaccine also has less stringent cold storage requirements. It requires long-term storage at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) and is stable for 30 days at 2 ° to 8 ° C (36 ° to 46 ° F). Vaccines from Pfizer and BioNTech, on the other hand, require temperatures of 70 ° C (minus 94 ° F) or less.

An emergency use authorization for the Moderna vaccine would give the company the green light to increase manufacturing to provide protection against Covid-19 to more Americans. But as with the Pfizer / BioNTech vaccine, there won’t be enough doses for right away, so health officials will have to make tough decisions about who gets the vaccines first.

And an EUA is still a step forward from full approval, meaning there are still critical questions about the vaccine that need to be addressed with further clinical trials.

What we recently learned about the Moderna Covid-19 vaccine

The public first received details of the Moderna vaccine outside of company press releases in a backgrounder released by the FDA on Tuesday.

FDA

Looking at 30,351 participants in their Phase 3 clinical trial, Moderna’s latest results showed its vaccine to be 94.1% effective against confirmed Covid-19 disease that was producing symptoms. The study detected 185 cases of Covid-19 in the placebo group and 11 cases in the group that received the vaccine.

The vaccine is given in two doses spaced 28 days apart. However, it appears to start offering protection against Covid-19 soon after the first dose, with protection continuing to strengthen after the second.

In a presentation to the FDA Vaccines Committee, Moderna also pointed out that its vaccine not only prevents disease, but also appears to prevent infections, including infections that do not generate symptoms.

“There were about 2/3 fewer positive swabs in the vaccine group compared to the placebo group at the time of pre-dose 2, suggesting that some asymptomatic infections start to be prevented after the first dose,” according to the Moderna briefing.

This is extremely valuable in fighting the Covid-19 pandemic. The virus has shown an ability to spread between people before infected people show symptoms and some infected people can be completely asymptomatic. This means that people can unintentionally spread the virus. But with a vaccine that reduces asymptomatic infections in addition to disease, the spread of Covid-19 can be more easily controlled.

However, this week’s results also shed light on the side effects of the Moderna vaccine. In the Phase 3 trial, about 16% of people in the vaccinated group had a serious adverse reaction, defined by the FDA as a reaction that requires medical attention and prevents people from going about their daily lives.

“The most common solicited adverse reactions associated with mRNA-1273 [Moderna vaccine] were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44 , 8%) and chills (43.4%); serious side effects occurred in 0.2% to 9.7% of participants, were more common after dose 2 than after dose 1, and were generally less common in participants aged 65 years or older compared to younger participants, ”according to Moderna’s briefing to the FDA.

The presentation also acknowledged that many critical issues remain unresolved. The first is the duration of protection against the vaccine, which will require ongoing monitoring of clinical trial participants and potential beneficiaries under a EUA.

There is also limited information on how well the vaccine works in people with weakened immune systems and pregnant women. There is no information on the effectiveness of the vaccine in people under the age of 18 since they have been excluded from clinical trials. It is also unclear to what extent the vaccine blocks transmission compared to other measures such as wearing face masks and social distancing.

Moderna has committed to monitoring its pool of trials for two years and will conduct additional studies among people who receive the vaccine as part of EUA to get these questions answered.

In the meantime, the FDA will review the recommendation of its advisers. The FDA granted the Pfizer / BioNTech vaccine a EUA just over a day after receiving a vote of confidence from the vaccine advisory committee, so approval for the Moderna vaccine could be obtained as early as Friday.