The FDA team unanimously recommends Moderna Covid intensified injections to at-risk adults

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On Thursday, an important advisory committee of the Food and Drug Administration unanimously recommended that people 65 years and older and other vulnerable Americans be vaccinated against Moderna’s Covid-19 vaccine. Voting is a critical step before the United States begins to give some of the more than 69 million people initially vaccinated with the vaccine for the third time.

The non-binding decision of the FDA Vaccine and Related Biological Products Advisory Committee will align Moderna’s guidelines with the third shot of Pfizer-BioNTech vaccine. Less than a month ago, these vaccines were licensed to a wide variety of Americans, including the elderly, adults with underlying diseases, and people who work or live in high-risk environments, such as health care and grocery store workers.

Although the agency does not always follow the recommendations of its committees, it does so often. The FDA may make a final decision on the Moderna booster within a few days. The CDC Vaccine Advisory Committee is expected to vote on the FDA’s proposal next week. If it recommends approval and the CDC approves it, eligible Americans who completed the immunization at least six months ago can start the booster injection immediately.

For scientists inside and outside the government, boosting injections has always been a controversial topic, especially when many people in the United States and other parts of the world have not even received a dose of the vaccine. The World Health Organization is urging rich countries to postpone the distribution of boosters, and some scientists say they do not believe that most Americans need boosters now.

When the FDA committee met last month, they rejected a proposal to distribute booster shots of Pfizer and BioNTech vaccines to the public. Some committee members at the time said they were worried that there was not enough data to make recommendations, while others believed that the third shot should be limited to certain groups.

After Moderna voted unanimously on Thursday, committee member Dr. Patrick Moore stated that the data submitted by the company to authorize the booster was “not well explained”, adding that he voted for “intuition”.

“The data itself is not strong, but it will definitely move in the direction of supporting this vote,” he said.

Some members said that the intensified injection should prevent the so-called breakthrough infection, which they said is essential to protect medical institutions from being overwhelmed, while other members said that the third injection should ensure that high-risk groups do not develop serious diseases. Some committee members also suggested that young people may not need boosters because the initial injections in these groups are still effective.

Another member, Dr. Paul Offit, emphasized that most people who received the first two doses of Moderna vaccine are still well protected, and expressed his hope that the recommendation will not convey “misinformation” to the public.

“If we try to prevent the inevitable, that is, the decline in neutralizing antibodies and the weakening of protection against mild or asymptomatic infections, then this is a high standard that no other vaccine can achieve,” he told his colleagues.

As the rapidly spreading delta variant continues to spread, the Biden administration hopes to provide the American population with additional doses to ensure long-term and lasting protection from serious illness, hospitalization, and death.

On Thursday, Dr. Peter Marks, the FDA’s top vaccine regulator, addressed the committee before the vote, telling the panel that the agency encourages “all different views” on “complex and evolving” data.

“That said, as we continue, I will ask us to do our best to focus our deliberations on science related to the application being considered today, rather than operational issues related to boosting activities or related to global vaccines. On issues related to fairness,” he added.

Moderna applied to the FDA for a booster dose authorization on September 1. The company said the results are based on a clinical trial of approximately 170 adults, which is less than the 318 people who studied Pfizer’s booster dose. Moderna stated that the third injection with a half-dose of 50 micrograms for the first two injections is safe and will produce a strong immune response.

The company’s director of infectious disease research, Dr. Jacqueline Miller, said in a speech on Thursday that after approval, the company plans to send a letter to healthcare providers explaining the consequences of the third injection. Dose difference.

The company wrote in a document released by the FDA on Tuesday that the side effects of Moderna boosters are comparable to those after the second dose. Most adverse reactions are of low severity, and Moderna reported that trial participants did not develop rare cases of cardiac inflammation, myocarditis, or pericarditis for up to 29 days after receiving the booster.

Before recommending the third needle, the expert group listened to many speeches, including presentations from the Israeli health authorities, that Israel began to provide boosters for its population earlier than many other countries. The country mainly uses Pfizer vaccines, but some Moderna boosters are also provided.

Sharon Alroy-Preis, Director of Public Health Services of the Israeli Ministry of Health, said that since the start of its booster campaign in late July, Israel has performed 3.7 million third injections, of which about three One-third of the additional injections are for people 60 years and older. panel.

The data she provided showed that people who received the booster dose were less likely to be infected with Covid or have a serious illness. She said that so far, officials have identified 17 cases of myocarditis or pericarditis after the third dose.

“I think when we look at all the data in Israel so far, we can say that enhanced dose management has helped Israel reduce infections and serious cases,” she said.

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