FDA OKs Regeneron antibody EUA; AstraZeneca shows positive vaccine results

The antibody therapy administered to President Donald Trump while he was hospitalized with COVID-19 was…

The antibody therapy administered to President Donald Trump while he was hospitalized with COVID-19 was granted emergency use authorization, providing yet another tool in the toolbox for health systems battling surging cases and hospitalization around the country.

Regeneron’s (REGN) antibody cocktail therapy was authorized by the U.S. Food and Drug Administration (FDA), which offers a treatment option for high-risk mild to moderate COVID-19 adult patients, as well as is safe for children 12 years and older.

Regeneron said in a statement Saturday that the demand is likely to outpace supply initially.

“The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of our antibody cocktail,” said CEO Leonard Schliefer.

“Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the … antibody cocktail is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available global supply as we continue our collaboration with Roche,” he said.

While antibody treatments have been increasingly in focus as they potentially offer protection against the virus in addition to being able to treat those infected, other treatments are also showing potential.

Merck (MRK) announced it was acquiring OncoImmune, which has shown positive Phase 3 clinical trial results for a COVID-19 treatment.

The treatment “showed a 60% higher probability of improvement in clinical status, as defined by the protocol, compared to placebo. The risk of death or respiratory failure was reduced by more than 50%,” according to Merck, which added the study will be submitted for peer review in a journal.

In addition, an arthritis drug manufactured by Roche (RHHBY) is back on the radar after a study by Imperial College London showed possible positive results— even after the company abandoned its own trial after showing it didn’t improve conditions for hospitalized COVID-19 patients. But there are ongoing trials, such as one showing the drug may help keep patients off ventilators.

In a statement to Yahoo Finance, Roche said that it is evaluating additional studies, “to determine if Actemra may provide potential benefit to certain groups of patients.”

Medical technicians work at a Drive-Thru coronavirus disease (COVID-19) testing facility at the Regeneron Pharmaceuticals company's Westchester campus in Tarrytown, New York, U.S. September 17, 2020. Picture taken September 17, 2020. REUTERS/Brendan McDermid
Medical technicians work at a Drive-Thru coronavirus disease (COVID-19) testing facility at the Regeneron Pharmaceuticals company’s Westchester campus in Tarrytown, New York, U.S. September 17, 2020. Picture taken September 17, 2020. REUTERS/Brendan McDermid

Vaccine news: the good and the bad

Meanwhile, the vaccine developed by Oxford University in collaboration with AstraZeneca (AZN) showed positive results from late-stage trials in the U.K. and Brazil, with an average of 70% efficacy. The company noted that an initial half dose with a full booster produced 90% efficacy and two full doses provided less protection at 62% efficacy, leading to the average of 70%.

Ruud Dobber, U.S. head of AstraZeneca, told Yahoo Finance Monday that the interesting results from the Brazil trial with a half dose could mean an expansion of the U.S. trial, and the company will be in touch with the FDA this week to discuss.

“We are going to decide whether we are going to add an additional arm with a half dose and a full dose as a boost,” he said.

And unlike the frontrunners in the U.S. vaccine race, AstraZeneca offers the most affordable vaccine option to-date at less than $3, according to some agreements with governments, compared to $20 and higher with the mRNA platform vaccines.

But one analyst said AstraZeneca’s efficacy numbers were skewed to look more positive, and it was unlikely to be approved in the U.S. — which put pressure on the stock early Monday.

“The company is likely to be roundly criticized today for their disclosure, since the safety disclosure simply states that ‘no serious safety events related to the vaccine have been confirmed’ which is hardly reassuring,” said SVB Leerink analysts.

The analysts criticized AstraZeneca for embellishing the results by using the 90% efficacy from a small sub-set of trial participants.

“We believe that this product will never be licensed in the US,” the analysts said, citing the trial design does not match some FDA requirements for target populations.

To that, specifically on the criticism of not as much diversity, Dobber said the company is conducting global trials — in countries like Japan, South Africa and Brazil — in addition to enrolling a high percentage of minority groups in the U.S. To-date, only a third of the anticipated 30,000 U.S. participants have been enrolled, Dobber noted.

SVB Leerink noted that strong results from mRNA platforms, which some had said validates not just the technology but also the specific attack method used on the virus, mean the lower efficacy in AstraZeneca shows the latter may not hold true across platforms.

But Dobber said the vaccine is effective, and a full data set will be published by the end of the week in a peer-reviewed journal.

“Irrespective of the dosing scheme, clearly no one got ill,” he said. “Overall, the data set is very comprehensive and very positive.”

AstraZeneca told Bloomberg the criticism was harsh and that more time was needed to make a judgement on what actions the U.S. regulatory body might take.

If less effective, it could potentially impact Johnson & Johnson’s technology, similar to AstraZeneca’s, but also puts other technologies in question, though the analysts noted vaccine candidates from Novavax (NVAX) and the collaboration between GlaxoSmithKline (GSK) and Sanofi (SNY) may hold more promise.

The vaccine news is being watched closely as the pandemic worsens in the U.S., with health experts warning of a post-Thanksgiving surge.

More than 83,000 are now hospitalized nationwide, and daily cases continue to be climb, with a record-breaking 200,000 cases reported Friday. The U.S. is still number one in the world with more than 12 million, or about one-fifth, of the global case count. Wyoming is among the worst-faring states, with a 67% positivity rate.

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