Coronavirus Update: AbbVie Jumps Into Antiviral Research With Scripps Pact
Executive Summary
AbbVie is taking the plunge into the highly competitive area of antiviral research through a new alliance, while Pfizer files for US approval of an additional mRNA booster shot and a vaccines group is unhappy about planned IP waivers.
AbbVie Dives Into Heated Antiviral Space With Scripps Pact
AbbVie Inc. is teaming up with non-profit Scripps Research to develop direct-acting anti-viral treatments for COVID-19. While drug development during the pandemic has focused mainly on vaccines, emerging antiviral treatments are gaining ground so AbbVie and Scripps must contend with the likes of Pfizer Inc.'s Paxlovid (nirmatrelvir/ ritonavir), Merck & Co., Inc.'s Lagevrio (molnupiravir) and Gilead Sciences, Inc.'s Veklury (remdesivir) which are already available.
Paxlovid is expected to make $22bn this year, while Merck anticipates $5bn to $6bn in Lagevrio sales in the same period. The partners are optimistic, however. "We believe our SARS-CoV-2 research program has the potential to impact significantly the ongoing gaps in patient needs to move from pandemic to endemic COVID-19," said Scripps CEO Peter Schultz. Developing next-generation oral antivirals could help address the emergence of new variants and combat more contagious, aggressive and severe strains, AbbVie’s head of R&D Tom Hudson added.
Scripps hosted an initial COVID-19 research program through its drug discovery and development division, Calibr, which was funded by the Bill & Melinda Gates foundation. The non-profit is ranked as the number one stand-alone biomedical research institute in the US.
Pfizer and BioNTech Eye Fourth Jab
Pfizer and BioNTech SE filed a submission with the US Food and Drug Administration on 15 March for emergency use authorization of a second Comirnaty vaccine booster in people aged 65 or older.
The US major’s CEO Albert Bourla noted last week that data shows four doses of Comirnaty significantly improves protection against the Omicron variant compared with three doses after three to six months. The prospect of a fourth jab has been discussed by industry experts amid concerns of waning efficacy over time, but this filing is the first tangible step taken to date.
Pfizer and BioNTech’s filing contained real-world data from a study in Israel, where second booster jabs are already available to those aged over 60, health workers and the immunocompromised. Israeli health ministry data released in January showed a fourth dose doubled protection against infection and increased protection against severe disease by three to five times compared with those who had receives three doses.
The go-ahead for a fourth jab could help further boost sales of Comirnaty, which has taken the lead over rival vaccines such as Moderna, Inc.’s Spikevax primarily due in part to better manufacturing capacity. (Also see "Moderna’s Bancel Dismisses GSK And Sanofi Challenge In mRNA Vaccines" - Scrip, 11 Mar, 2022.)
Vaccine Alliance Head Slams Leaked IP Waiver Draft
The head of a vaccines group has criticized a leaked draft agreement in vaccine trade-related aspects of intellectual property rights (TRIPS) waiver negotiations. The agreement to waive IP rights for COVID-19 jabs between India, the US, the EU and South Africa is expected to be signed soon.
Max Lawson, co-chair of the People’s Vaccine Alliance said, “This is a tribute to millions of campaigners across the world who have demanded a People’s Vaccine, but this leaked proposal is not the comprehensive TRIPS waiver demanded by over 100 governments. Unless it is significantly improved it will not do enough to bring an end to vaccine apartheid and ensure access for all.”
Developing countries such as India have pushing for an IP waiver to facilitate universal and fair access to COVID-19 vaccines. India’s waiver application covers diagnostics and therapeutics for prevention, containment and treatment for COVID-19.
However, the current proposal does not sufficiently address patents beyond the existing flexibilities in the TRIPS agreements and ignores barriers such as trade secrets that obstruct vaccine manufacturers, Lawson claimed. The agreement focuses on vaccines and overlooks COVID-19 treatments, he added.
“In a crisis, half measures are not acceptable. Every barrier to accessing these crucial vaccines and treatments must be cleared away,” Lawson said, urging member states to return to negotiations and design a more comprehensive waiver.