FDA could develop national strategy for Covid-19 booster injections in early September



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The strategy would apply to all people vaccinated. A decision for people who are immunocompromised and at increased risk of the virus is expected sooner, the official said on Thursday.

The United States has yet to recommend recalls for people vaccinated against Covid-19. But officials in the Biden administration have repeatedly asserted that if a recall is recommended, the United States will have the supply, personnel and capacity to deploy it effectively.

An FDA spokesperson told CNN in a statement that the FDA, along with the United States Centers for Disease Control and Prevention and the National Institutes of Health, are evaluating potential solutions to questions about the use of doses. Covid-19 vaccine booster.

“Agencies are engaged in a rigorous, science-based process to determine if or when a recall may be necessary,” FDA spokeswoman Abby Capobianco said in a statement.

Capobianco said “in the near future” that the FDA will share information on potential options for immunocompromised people, who face a greater risk of the virus than healthy people.

The decision to go ahead on a recall plan comes as the country continues to grapple with the contagious Delta variant of Covid-19, which has increased cases and hospitalizations mainly among unvaccinated people.

The Biden administration has struggled to meet its goals by vaccinating the eligible American population against Covid-19. And in recent weeks, the president has pivoted his White House’s approach to getting more people vaccinated, offering cash incentives, instituting a vaccine requirement for federal workers, and encouraging other states and cities to follow the guidelines. New York traces with a vaccine requirement for certain businesses or locations.

The daily rate of Covid-19 vaccinations, meanwhile, is the highest in nearly seven weeks, according to data from the U.S. Centers for Disease Control and Prevention. As of Thursday, 49.9% of the eligible U.S. population is fully immunized.

The World Health Organization on Wednesday called for a moratorium on recalls until at least the end of September, to allow at least 10% of the population in each country to be vaccinated. But despite the organization’s global call, Germany, France, Israel and the UK have all indicated they will move forward with plans to start administering booster shots of Covid-19. from September or before.

While he did not discuss the timing of a recall recommendation, U.S. Surgeon General Dr Vivek Murthy suggested on Wednesday the country is able to contribute to the global immunization effort while continuing to provide vaccines to Americans – even potential booster doses.

“I recognize why the WHO has raised this concern, they are concerned around the world and frankly so are we, because we are not going through this pandemic unless we make sure countries around the world have enough vaccines to. make sure cases get down and stay down, ”Murthy told MSNBC. “If there is an uncontrolled spread of the virus to another country, which means variants can arise, those can end up here in the United States, we don’t want that.”

“But I don’t think we necessarily have to choose between vaccinating the rest of the world and providing the vaccines, potentially including boosters if they are needed, that our country needs,” said Murthy.

Dr Anthony Fauci, director of the National Institutes for Allergies and Infectious Diseases, said on Tuesday that people with weakened immune systems may need extra protection after receiving a Covid-19 vaccine, and there is an effort to provide vaccine boosters. population “very soon”.

CDC vaccine advisers have met to discuss whether immunocompromised people might need additional protection against a vaccine booster, but have yet to make a formal recommendation or vote on guidance.

“We are working to get the regulatory mechanism in place very soon to give these people a boost that could raise their immunity to where it should be, if possible,” Fauci added.

Moderna’s Covid-19 vaccine has shown 93% efficacy against symptomatic illnesses for six months, and the company plans to complete its application for full FDA approval this month, the company said Thursday. And in July, the makers of another mRNA vaccine licensed in the United States, Pfizer / BioNTech, released efficacy data showing an overall six-month efficacy of 91% – with a possible decrease towards the end of this. period. Like Moderna data, Pfizer’s tracking data was collected prior to the Delta-related push.

Moderna believes the Delta variant will lead to more breakthrough infections and that recalls may be needed before winter, according to slides released ahead of the company’s earnings call Thursday.

Pfizer said on an investor call last week that it intended to submit a recall for emergency use authorization review as early as August.

This story has been updated with additional information.

CNN’s Naomi Thomas, Jason Hanna, and Virginia Langmaid contributed to this report.

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