A group of institutional investors from Nomura, BMO, GAM and more than 60 others representing trillions in assets are now calling on Covid-19 vaccine developers to link their executives’ pay to ensure the vaccines are available globally.
‘It is clear that currently a large part of the world population still does not have sufficient and equitable access to vaccines,’ the investors said in explaining their reasoning behind Thursday’s letter to the execs at Pfizer, Moderna, AstraZeneca and J&J.
The push comes as all of the companies have pledged to make lower-cost versions of their vaccines available, but many countries still lack crucial supplies. The WHO has sought to reach the mark of 70% vaccinated in every country after almost half of its participating member countries failed to reach 40% vaccinated in 2021, according to the Financial Times.
House Republican calls for Omicron treatment hearing
Rep. Michael Burgess (R-TX) is calling for a hearing with federal policy leaders to get a better understanding of how Congress can improve the US response, including via the distribution of effective treatments, to battle the new variant Omicron, according to a letter sent yesterday to House Energy & Commerce committee chair Frank Pallone (D-NJ).
‘It would be beneficial to invite various agencies such as the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority to testify on the development process for COVID-19 therapeutics and antivirals, such as molnupiravir and sotrovimab, and how we can ensure adequate distribution of these options,’ he wrote.
Burgess also noted how due to its expected effectiveness against the Omicron variant, shipments of GlaxoSmithKline and Vir’s sotrovimab were paused to ensure reserves would not be depleted as the variant spread. ‘Though this decision has since been reversed, I am very concerned about the limited supply currently available,’ he wrote.
The Senate health committee is set to meet next Tuesday to hear from CDC, FDA and NIH officials, including acting FDA commissioner Janet Woodcock and President Biden’s top medical advisor Tony Fauci.
Manufacturing difficulties mean there will be a lot more of Merck’s pill than Pfizer’s in the next few months
Until at least March, the US is going to have hundreds of thousands of more courses of Merck’s pill to treat Covid-19, known as molnupiravir, than Pfizer’s pill Paxlovid, even as the US has purchased 20 million pills from Pfizer.
Part of the reason for this early discrepancy is that while Pfizer’s pill might be more effective than Merck’s pill (no one ran a head-to-head trial), Pfizer’s pill is also difficult to manufacture.
Chemist Derek Lowe wrote in Science recently about how and why Pfizer’s pill is difficult to make, and how there are shortages of the reagents used to make it.
‘So there’s a shortage of the stuff, that’s used to make the stuff, that’s used to make the stuff, that’s used to make two of the starting materials for Paxlovid. And that’s just one of the reagents,’ he wrote. ‘Remember, as complicated as this may seem, there’s a lot more to setting up a production supply chain than this! What it all means is that when someone says ‘Oh, we can just make Paxlovid in plants all over the world’, they have left out the rest of the sentence, which is ‘. . .if we can get the starting materials’.’
White House coronavirus response coordinator Jeff Zients also recently said in a press briefing that the US is offering whatever it can to help Pfizer, but the complex chemistry involved in creating the active ingredient in the pill means production takes about six to eight months.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.
The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.
Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)
Bursting at the seams and executing plans for swift expansion to support its manufacturing work for the mRNA vaccine out of Pfizer/BioNTech, Indianapolis-based Exelead has now been scooped up in a $780 million cash buyout deal.
Germany’s Merck KGaA, which bought out another mRNA manufacturer, AmpTec, early last year, has been beefing up its ops around lipids, which, in mRNA vaccines, play a key role in turning human cells into a mini—vaccine factories?
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For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
Jay Bradner, NIBR president (Jeff Rumans)
Alnylam was a few years ahead in the small interfering RNA (siRNA) space when Novartis jumped on the bandwagon in early 2020, licensing the company’s cholesterol-lowering drug Leqvio through its buyout of The Medicines Company. Less than a month after securing an approval, the pharma giant wants more where that came from.
Novartis is joining forces with Alnylam once again for the discovery and development of a regenerative siRNA-based therapy to treat end-stage liver disease, the companies announced on Thursday.
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Sosei Heptares is teaming up with a big-name partner: Alphabet’s Verily.
No financials were disclosed, but the pair will aim to use Verily’s immune profiling and Sosei Heptares’ GPCR drug design capabilities to develop a variety of new therapeutics. The collaboration will focus on GPCR drugs in the immunology, gastroenterology and immuno-oncology spaces, as well as other disorders with immunoprotective or immunopathogenic mechanisms, the companies said.
After showcasing clinical data at #ASH21 for a sickle cell disease candidate, Sanofi has decided to throw in the towel on its 8-year partnership with collaborator Sangamo — and return its rights to the candidate.
The gene editing biotech announced the ‘transition’ this morning, several days after Sanofi told Sangamo that the biotech was backing out of the deal. The Paris-based pharma giant will be returning its rights and obligations on SAR445136, a zinc finger nuclease gene-edited cell therapy back to Sangamo by the end of June.
Chris Perkin, Altasciences via Youtube
Altasciences CEO Chris Perkin has gone through several acquisitions in his 45-year career. And if there’s one thing he learned, it’s how not to go through an acquisition.
His company put that knowledge to use on Tuesday when it announced that it had acquired competitor Sinclair research, a preclinical contract research organization in Missouri. With the pickup, Altasciences gains 80 animal rooms, and full-service IND and NDA-enabling toxicology and safety pharmacology services.
https://endpts.com/covid-19-roundup-investors-call-to-link-ceo-salaries-to-vaccine-access-why-there-arent-more-initial-supplies-of-the-pfizer-pill/
