Fauci Says He Would Be ‘Astonished’ If Pfizer, Moderna And J&J Covid Vaccines Don’t Get Full FDA Approval



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Dr.Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, delivers remarks during a press briefing with Press Secretary Jen Psaki at the White House in Washington, United States, April 13, 2021.

Tom Brenner | Reuters

White House Chief Medical Advisor Dr Anthony Fauci expects coronavirus vaccines from Pfizer, Moderna and Johnson & Johnson to receive full approval from US drug regulators, he said. told CNBC on Tuesday.

“The data is about as good as it gets.… I would be amazed if these vaccines, namely mRNA and J&J, didn’t get full approval,” Fauci said on “Squawk Box”.

All three Covid vaccines are currently cleared for emergency distribution in the United States, but none of them have yet received full approval from the Food and Drug Administration. Full approval would allow drug makers to market injections directly to consumers and give employers more flexibility to mandate them.

The two-dose vaccines from Pfizer and Moderna use mRNA technology, while the single-injection vaccine from J&J uses an adenovirus.

More than 184 million people in the United States, or 55.5% of the population, are at least partially vaccinated against Covid, according to CDC data. Almost 160 million people, or 48% of the population, are fully vaccinated.

The pace of vaccinations in the United States has slowed since the spring, even as concerns about highly transmissible variants increase. Some people have argued that full vaccine approval would convince Americans on the fence to get vaccinated and give companies more confidence to implement a vaccine mandate.

“Even though we are still under an emergency use authorization, it is a little different from other emergency use authorizations, which are generally granted with not as much positive data as we have for these products,” Fauci said.

Pfizer and its German partner BioNTech were the first vaccine makers to seek full approval in May, followed by Moderna on June 1. Both vaccines were cleared for limited use in December.

“The effectiveness or efficiency in the real world is undisputed, so we will get full approval,” he added. “The question is, it’s just going to take a little longer.”

Fauci’s appearance on CNBC comes a day after U.S. health officials, including Fauci, met with representatives from vaccine maker Pfizer to discuss the potential need for Covid booster vaccines.

Pfizer said it was seeing signs that the immunity of its two-dose vaccine was waning over time and intended to seek permission for a booster. The company is also developing a booster to combat the highly contagious delta variant.

The FDA and the Centers for Disease Control and Prevention have publicly rejected Pfizer’s case for a third dose, issuing a joint statement last week that fully vaccinated people do not need an additional injection at this time.

Fauci described Monday’s conversation with Pfizer as primarily “a courtesy meeting.” However, he stressed that the discussion around booster shots “has absolutely nothing to do with the effectiveness of the vaccine.”

“These vaccines are very, very effective both in clinical trials and in real-world efficacy studies. Let me give you a compelling example: 99.5% of people who die from Covid are not vaccinated. Only 0.5% of those who die are vaccinated, “said Fauci, longtime director of the National Institute of Allergy and Infectious Diseases.

He said the real question is how long is the protection and at what level of protection.

“Does it go down and if so, in how long? And if you do a boost, how high do you get the response? It was all discussed but… there was nothing that came close to it. ‘a decision,’ he said.

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