• The Bill & Melinda Gates Foundation will commit up to $120 million to speed production of generic versions of molnupiravir, an experimental oral COVID-19 antiviral developed by Merck. The incentives, such as volume guarantees, and financial support for accelerating applications for WHO prequalification, are aimed at the eight generics producers that have entered into a voluntary license agreement with Merck, so that they sale up production capacity before gauging demand for molnupiravir. The licensees, who can supply 100 low-to-middle-income countries, have not shared their projections for production volume and cost – or pricing for their generic versions of molnupiravir.
Brook Baker, a Northeastern University professor who specializes in access to medicines and intellectual property and a senior policy analyst for Health GAP, said that Merck’s licensing deals exclude more than 30 upper-middle and lower-middle-income countries, including Malaysia, Mexico, Turkey and Ukraine, which suffered a large number of COVID-19 deaths and are home to substantial numbers of poor people. He Baker estimated that middle-income countries excluded from the licensing deals accounted for 30 million infections in the first half of 2021, and 50% of all infections in lower-middle-income countries. By his calculation, even if the eight generic versions become available and satisfy this demand in the licensed territories, Merck will be unable to meet the remaining 70% of global need.
Merck has not shared its intellectual property; instead, it is exploring additional licensing opportunities with the Medicines Patent Pool. “While any initiative to accelerate production and access, especially on the African continent and low-income countries, is welcome, the Gates Foundation investment is incomplete. Vaccine and treatment apartheid affect all low and middle-income countries today due to intellectual property barriers,” said Rohit Malpani, a former director of policy and analysis at Doctors Without Borders and now a board member at UNITAID, which backs the Medicines Patent Pool, adding “It is necessary also to tackle these patent barriers to ensure access to these medicines. The Gates Foundation should be throwing its considerable power and influence behind a waiver of intellectual property rules at the World Trade Organization, as well as pressuring Merck to expand the voluntary license to include all countries.” Source
• The US FDA updated authorizations for coronavirus vaccines from Johnson & Johnson, Moderna, and Pfizer/BioNTech, allowing boosters with a different vaccine, a strategy called ‘mix and match.” Source
• The EMA has started to evaluate an application from Roche for marketing authorization for Ronapreve, a monoclonal antibody combination from Roche and Regeneron, and it will work with the European Commission to fast-track marketing authorizations in all EU and EEA member states. Source
• The Financial Times reports that George Yancopolous, a Regeneron executive, made an unsubstantiated claim that the company’s monoclonal antibody treatment could have saved former US secretary of state Colin Powel, who died from complications of COVID-19 at age 84. Mr. Yancopolous was at a healthcare conference, criticizing the US government, which has spent $2.9 billion on the $2,100 per-dose treatment, for “…failure to communicate that cost tens of thousands, if not hundreds of thousands of lives.” He added that the company’s monoclonal antibody combination should be given to immunocompromised people instead of coronavirus vaccines, “We have shown very effectively that our [treatments] can substitute for people who don’t have their own antibodies, to prevent COVID. Don’t keep giving them a useless treatment, don’t give them the mirage, the illusion that there may be getting protection, actually give them something that will protect them.” Source
• As Russia’s COVID-19 death toll continues to increase, President Vladimir V. Putin announced a non-working week in the country starting on 30 October, a measure intended to stop the coronavirus from continuing to spread. Instead of a lockdown, nonessential workers are encouraged to stay home, while employers are encouraged to pay them at least the minimum wage. Source
• In some Caribbean countries, coronavirus cases are surging: in Barbados and the Dominican Republic, they have risen by 40 percent over the past week, while Anguilla, the Cayman Islands, Nevis, St. Kitts, St. Martin, and Trinidad and Tobago are reporting increases. Source
• The new US travel policy excludes foreign visitors who have recovered from COVID-19 and have had one dose of a two-dose coronavirus vaccine. In contrast, COVID-19 survivors who have had one dose of vaccine are eligible to receive the EU Digital COVID-19 certificate and considered fully vaccinated by the European Commission, Austria, France, Greece, Italy and Norway. Source
• Moderna issues a press release to announce that the US FDA granted Emergency Use Authorization for a booster half-dose of its coronavirus vaccine for people ages 18 through 64 who are in certain high-risk groups (because of pre-existing conditions and/or occupational or institutional exposure to SARS-CoV-2), and for people ages 65 and over. The booster was also authorized for use in people who were fully vaccinated with other authorized or approved vaccines. Source