Fauci calls milestone ’stunning;’ FDA issues new guidelines for addressing virus mutations

The United States hit a grim milestone on Monday, Feb. 22 — half a million people dead from Covid-19. And, as that milestone is crossed, President Biden has ordered flags on federal properties to be lowered to half-staff for the next five days.

A candle-lighting ceremony and a moment of silence will also be observed, and the President will address the nation, according to the The Hill.

Covid-19 deaths stand at 500,071 as of Feb. 22, according to Johns Hopkins Coronavirus Resource Center. The total number of people diagnosed with the virus in the U.S. is 28,174,133 (also rising).

Dr. Anthony Fauci, President Biden’s chief medical advisor, speaking with Chuck Todd on Meet the Press, called the half-million mark “stunning… It is historic. We haven’t seen anything even close to this for well over 100 years since the 1918 pandemic of influenza… This is a devastating pandemic. And it’s historic. People will be talking about this decades and decades from now.”

The CDC’s Covid Data Tracker is showing a downward trend in cases and deaths over the last 30 days, but according to Fauci, it’s not enough to loosen preventive measures. He told CNN, as reported by the New York Times, that he expects people in the U.S. may still be wearing masks up to a year from now, but he also predicted a return to “a significant degree of normality by fall.”

Nonetheless, he noted that in order for him to feel comfortable enough to no longer recommend universal masking, the downward trend in cases would have to get “to a baseline that’s so low there is virtually no threat… If you combine getting most of the people in the country vaccinated with getting the level of the virus in the community very, very low, then I believe you’re going to be able to say, for the most part, we don’t necessarily have to wear masks.”

According to the CDC, 63.1 million vaccine doses have been administered thus far.

But even as the vaccines are rolled out, with most states so far receiving most of their first phase allotments, concerns have arisen over the variants of Covid-19 that are cropping up, particularly the B.1.1.7 variant, which was first reported in the United Kingdom, as previously reported by BreakingMED.

These emerging mutations beg the question — Will the current vaccines protect against these new versions of Covid-19? And drugmakers are scrambling to put their products to the test, as Stat News reports.

In response, the FDA updated its Emergency Use Authorization for Vaccines to Prevent Covid-19 guidance for vaccine developers that already have EUAs or those that are seeking to amend their EUAs in light of these new strains.

“At this time, available information suggests that the FDA-authorized vaccines remain effective in protecting the American public against currently circulating strains of SARS-CoV-2. However, if there is an emergence of SARS-CoV-2 variant(s) in the U.S. that are moderately or fully resistant to the antibody response elicited by the current generation of Covid-19 vaccines, it may be necessary to tailor the vaccines to the variant(s),” the agency said in a statement.

The agency also issued new guidance for test developers called the Policy for Evaluating Impact of Viral Mutations and Covid-19 Tests.

“The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test,” the agency wrote in its statement. “The FDA identified a few tests that are known to be impacted by emerging viral mutations, though at this time the impact does not appear to be significant.”

And of course, these variants beg yet another question — what about the monoclonal antibody products that are being used against the virus? And the FDA has new guidance for that as well in its Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the Covid-19 Public Health Emergency. It also updated the guidance for drugs and biological products in its Covid-19: Developing Drugs and Biological Products for Treatment of Prevention.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,926,192,927,151,928,925,934