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Sec. Alex Azar: Antibody Treatments, Vaccines 'Weeks' Away

Former FDA doc calls Azar's claim 'happy talk' as most experts expect a much longer time before widespread rollout of either a vaccine or effective treatment.
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A top U.S. health official pleaded with Americans Sunday to take precautions against spreading Covid-19 and claimed that antibody treatments and vaccines are only "weeks" away -- just as the total number of known Covid-19 infections in the U.S. shot past 8 million.

"We are so close. We are weeks away from monoclonal antibodies for you, for safe and effective vaccines," Health and Human Services Sec. Alex Azar said on the NBC News' "Meet the Press," adding that "we need to bridge to that day" by washing hands, watching distance and wearing face coverings.

Azar later in the interview said that timeline could be weeks or "just a couple months away" for the treatments and vaccines.

While currently unavailable to the vast majority of Covid-19 patients, an antibody treatment by Regeneron  (REGN) - Get Regeneron Pharmaceuticals, Inc. Report was believed to play a role in the apparently rapid recovery of President Donald Trump, who is 74, after his recent infection with the novel coronavirus. Former New Jersey Gov. Chris Christie, who has asthma, also recovered from the virus after getting an antibody treatment from Eli Lilly  (LLY) - Get Eli Lilly and Company Report.

But no antibody treatments have been proven safe and effective through clinical trials and most experts say a vaccine -- even in the best-case scenario -- wouldn't be widely available until later in 2021, despite Trump's earlier claims that a vaccine could be available by election time.

When asked to respond to Sec. Azar's comments, a former Food and Drug Administration official told TheStreet by email on Sunday that the words are likely "happy talk" to make people feel better about the pandemic that has so far killed more than 220,000 Americans.

"There's an old saying at the FDA, where I spent 15 years as a medical reviewer and office director, that all approval decisions are based on incomplete data, some more incomplete than others. In other words, you can always be surer of your decision with more patients treated for a longer time, but at some point, you have to make a judgment call. FDA's scientists have not gotten to that point, so you can be sure that Sec. Azar, a lawyer with no scientific or regulatory expertise, cannot make that judgement. His remarks are happy talk, pure and simple," said Dr. Henry I. Miller, who was a founding director of the FDA's agency's Office of Biotechnology.

Furthermore, he said, even if monoclonal antibodies -- which lack phase 3 data -- prove to be safe and effective, they will be both "in short supply for the foreseeable future and quite expensive, so it's unlikely they will be a near-term gamechanger."

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At the same time, said Miller, without complete phase 3 data on vaccines, "it's difficult to predict when any will be approved, either via conventional approval or under emergency-use authorization." 

The FDA, in a controversial move, OK'd in August convalescent plasma treatments -- which rely on antibody-rich plasma -- for emergency use. 

Several companies have said they are working on products using the technology or that are related to the technology, including Regeneron, Eli Lilly, Japanese drugmaker Takeda  (TAK) - Get Takeda Pharmaceutical Co. Ltd. Report and Emergent BioSolutions  (EBS) - Get Emergent BioSolutions Inc. Report

Hopes for quick vaccines and treatments, however, have suffered several blows recently. Vaccine clinical trials by AstraZeneca  (AZN) - Get Astrazeneca PLC Sponsored ADR Report and Johnson & Johnson  (JNJ) - Get Johnson & Johnson Report have been "paused" in the U.S. after participants fell ill. Also, last week, trials for Eli Lilly's  (LLY) - Get Eli Lilly and Company Report monoclonal antibody treatment have been paused for the same reason.

In addition, a drug eyed since early in the pandemic as a potential treatment for the novel coronavirus, Gilead Science's  (GILD) - Get Gilead Sciences, Inc. Report remdesivir, has been thrown into question late last week by a huge study backed by the World Health Organization. The study looked at remdesivir, as well as hydroxychloroquine, which has been touted by the president as a treatment for Covid-19, and lopinavir, an HIV drug.

"These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay," according to the study.

But Miller said there's hope in one part of Azar's statement: Keeping distance from others, wearing protective face masks and washing hands will help in combating the virus.

"Sec. Azar is correct that Americans need to comply with the kinds of practices that we know reduce transmission of Covid-19: masks, frequent and thorough hand washing, avoidance of crowds in poorly ventilated spaces, and testing and quarantine. But these practices won't be merely 'a bridge' -- they will be with us for the foreseeable future."

This story has been updated.