President Trump pressures FDA to quickly approve COVID vaccine
Fox News correspondent Kristin Fisher has the latest from the White House on 'Special Report'
President Trump on Friday said distribution of the Moderna vaccine will start "immediately" after it was "overwhelmingly approved" this week, while signaling to European nations that have been "hit hard" that coronavirus vaccines would be "on their way" to them, as well.
"Moderna vaccine overwhelmingly approved. Distribution to start immediately," Trump tweeted.
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"Europe and other parts of the World being hit hard by the China Virus—Germany, France, Spain and Italy, in particular," he continued. "The vaccines are on their way!!!"
The president's tweet comes after the U.S. Food and Drug Administration approved an emergency use authorization (EUA) for the use of the Moderna vaccine Thursday. The vote was not the final vote, however.
Despite the president’s tweet, FDA Commissioner Stephen Hahn said that the FDA will "rapidly work toward finalization and issuance of an emergency use authorization."
Hahn said the FDA has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, "so they can execute their plans for timely vaccine distribution."
As for aid to European nations, the president, last week, signed an executive order that ensures Americans have access to the coronavirus vaccine before the U.S. government begins aiding nations around the world.
Senior administration officials told Fox News last week that the president will re-emphasize to the American people that the "priority has been an America First approach."
"We work with the world," Trump said last week upon signing the order. "We’re working with the world."
The president said the order ensures "the U.S. government prioritizes the getting out of the vaccine to American citizens before sending it to other nations."
A senior administration official told Fox News last week that the "priority" is to distribute to Americans, and predicted that international assistance could come "late spring, early summer," and after they "achieve vaccinating those [in the U.S.] who have a desire to be vaccinated."
The FDA's advisory board vote to endorse Moderna’s coronavirus vaccine was 20-0, with one committee member abstaining.
The committee was charged with voting on the following question: "Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risk for use in individuals 18 years of age and older?"
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Although significant, the committee’s vote in favor of emergency use authorization (EUA) is not final. The vote will now go before FDA officials who will decide whether to grant EUA based on the committee’s findings. Such approval would come about a week after the regulatory agency granted EUA to Pfizer’s COVID-19 vaccine for individuals aged 16 and older, which states have begun rolling out to health care workers this week.
An FDA committee’s review of Moderna’s coronavirus vaccine emergency use authorization application found "no specific safety concerns" in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection, potentially paving the way for a second COVID-19 jab to enter the scene.
The panel also found that the vaccine reduced the risk of confirmed COVID-19 – including severe cases – occurring at least 14 days after the second dose.
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The committee was careful to note that there wasn’t enough data to evaluate the duration of protection in relation to the vaccine, effectiveness in certain high-risk populations such as immunocompromised individuals, effectiveness in individuals who have previously been infected with SARS-CoV-2, or effectiveness in pediatric populations. There also wasn’t enough data for the committee to evaluate future vaccine effectiveness in relation to changes in the virus, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19, effectiveness against mortality, or effectiveness against transmission of SARS-CoV-2.
Not unlike Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adverse reactions such as pain at the injection site, fatigue, headache, muscle pain, joint pain and chills. The reactions were characterized as generally mild to moderate.
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The FDA last week approved Pfizer and BioNTech’s vaccine, which has been distributed throughout the country to health care and front-line workers this week.
From an accessibility standpoint, the Moderna vaccine, which proved more than 90% effective in late-stage clinical trials and requires two doses given weeks apart, does not require ultra-cold storage requirements, and comes in smaller batches, compared to the 975 doses with the Pfizer-BioNTech vaccine.
Upon formal FDA approval, which would mark the first such approval for Moderna, Americans could see an initial 6 million doses distributed next week.
Fox News’ Madeline Farber, Alexandria Hein and Kayla Rivas contributed to this report.
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