Covid-19 roundup: Top analyst: Regeneron EUA likely this week — unless Trump takes a turn for worse; UK says less than half of residents will be vaccinated
With Regeneron’s Covid-19 antibody cocktail being used to treat the highest-profile patient on the planet, one top analyst expects an EUA could be on the horizon.
SVB Leerink’s Geoffrey Porges sent a note to investors early Monday morning attempting to parse through what the use of REGN-CoV2 to alleviate President Donald Trump’s symptoms means for the company. Given that the therapy was used at all, Porges estimates that the FDA was already reviewing its EUA application and that the authorization could come “in a matter of days.”
Porges notes that the President is taking the higher dose of REGN-CoV2 and is likely one of the first patients taking it in combination with both remdesivir and dexamethasone. This suggests that Trump not only had a high viral load but also a low immune response. Early public data from REGN-COV2 studies showed that the higher dose was better at reducing viral load, but worse in reducing symptoms.
All indications, however, point to a more positive readout for REGN-CoV2 than what had been publicly disclosed. The decision to administer the cocktail in such a prominent case would not have been made without Regeneron and the FDA being more bullish than they’ve let on, Porges writes:
Assuming Regeneron has seen much more pre-clinical and clinical data than has been disclosed, and then assuming that the White House medical staff and their advisers, as well as the FDA, had access to summaries of all that data when the treatment of POTUS was contemplated, then their decision to use the product can be construed as a positive indicator about the drug’s clinical profile. Furthermore, the decision could be validated if the FDA grants REGN an EUA for REGN-CoV2 in the next few days – this would suggest that the agency was reviewing the application already, and had reached a sufficient degree of comfort to endorse using it in such extraordinary circumstances.
Later Monday morning, Regeneron CSO George Yancopoulos revealed in a CNBC interview that the biotech has also offered its regimen — which is also being tested as a prevention for those who’ve been exposed to the coronavirus — to Democratic presidential candidate Joe Biden and his team.
WOW: Yancopoulos tells @HallieJackson Regeneron has reached out to the Biden team to offer their antibody cocktail to them
— Meg Tirrell (@megtirrell) October 5, 2020
None of this comes without substantial risk, however. Most notably, Regeneron is risking its reputation that Trump will make a recovery from Covid-19, Porges says, and a failure will raise significant questions.
“If POTUS does badly, will that cause physicians, consumers and investors to lose confidence in REGN-CoV2?” he writes. “If there are unusual complications of his COVID, are they blamed on REGN-CoV2?”
Ultimately, Regeneron likely decided that the benefits outweigh those risks. — Max Gelman
Less than half of UK citizens will get a vaccine, government says
Not everyone in the UK will receive a Covid-19 vaccine — mostly just those at risk, the government’s vaccine task force head Kate Bingham told the Financial Times.
If a vaccine is approved, the UK plans to inoculate less than half its population, or roughly 30 million of 67 million people, according to the FT. Bingham called the idea of vaccinating everyone “misguided.”
“There’s going to be no vaccination of people under 18. It’s an adult-only vaccine, for people over 50, focusing on health workers and carehome workers and the vulnerable,” she told the FT.
According to interim advice posted by the UK’s Joint Committee on Vaccination and Immunisation last week, care home residents and workers would be prioritized first. Next comes those older than 80 and health and social care workers. From there, patients would be ranked by age.
Bingham said inoculating a broader portion of the population might make sense if a vaccine proves to be 95% effective. But for now, the focus will be on those most at risk of severe illness.
David Nabarro, special envoy to the WHO, also told the FT that the Covid-19 vaccine won’t be available to just anyone. “We’re not fundamentally using the vaccine to create population immunity, we’re just changing the likelihood people will get harmed or hurt. It will be strategic.”
The EMA announced last week that it began a rolling review of AstraZeneca’s Covid-19 vaccine with Oxford University. The agency’s human medicines committee is already looking at the candidate’s first batch of data, in an effort to speed up the approval process. — Nicole DeFeudis
India’s hoping for 500 million vaccine doses by July
India’s health minister Harsh Vardhan said the country is looking for up to 500 million Covid-19 vaccine doses by July.
That would be enough to cover 250 million of India’s 1.3 billion residents, according to a Reuters report. Vardhan told the news organization that India’s government is focused on “fair and equitable” distribution of the doses. The health ministry is expected to present a list of those who will be prioritized to receive the vaccine, like frontline health workers, this month.
At more than 6.5 million Covid-19 cases, India has the world’s second highest caseload. Over 75,000 cases were reported in the last 24 hours, according to the World Health Organization’s tally. The country’s death toll is nearing 102,000.
In a rush to secure doses, the Serum Institute of India entered collaborations with Novavax and SpyBiotech, whose candidates entered Phase III and Phase I/II trials in September, respectively. The Serum Institute also struck a deal with AstraZeneca for 1 billion doses. While AstraZeneca’s vaccine trials are still on hold in the US due to a potentially serious adverse event suffered by a British patient, India has allowed the biotech to resume testing there. — Nicole DeFeudis
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