• India’s Everest Organics Ltd announces that it has started to produce the active pharmaceutical ingredient (API) for a generic version of molnupiravir, Merck’s experimental oral antiviral COVID-19 medicine, joining Divi’s Laboratories Ltd inmakingAPI for molnupiravir. Source
• CureVac issues a press release announcing that it is withdrawing its experimental COVID-19 vaccine, CVnCoV, from regulatory review to focus on a second-generation mRNA vaccine candidate in collaboration with GSK.CureVac estimates thattheir second-generation vaccine will enter late-stage clinical trials by Q2 of 2022. Source
• Sales of sotrovimab, a monoclonal antibody treatment for COVID-19, which was co-developed by GSK and Vir Biotechnology, have reached $1 billion in six months. The companies have reached a distribution agreement with the US government. A GSK spokesperson told Endpoints that it could “…confirm that the U.S. government has agreed to purchase sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19. As part of the agreement, which is worth $279,862,800, GSK will supply sotrovimab to the U.S. government.” Source
• The UK House of Commons Health and Social Care and Science and Technology Committees issues Coronavirus: lessons learned to date, the Sixth Report of the Health and Social Care Committee and Third Report of the Science and Technology Committee of Session 2021–22, which was meant to inform emergency responses, safeguard the future of vital public services, and benefit the wider health of the nation. It assessed six key areas of the response to COVID -19 (the country’s pandemic preparedness; the use of non-pharmaceutical interventions to control the pandemic; the use of test, trace and isolate strategies; the impact of the pandemic on social care; the impact of the pandemic on specific communities; and the procurement and roll-out of COVID-19 vaccines).
The Report noted that pandemic planning was “…too narrowly and inflexibly based on a flu model which failed to learn the lessons from SARS, MERS and Ebola,” and that the UK (and other countries) “…made a serious early error in not considering a more emphatic and rigorous approach to stopping the spread of the virus.” Serious mistakes included stopping community testing early in the pandemic and lack of transparency around information-sharing and decision-making; the Report noted that “Scientific accomplishment was hampered by operational inadequacy,” and that “A country with a world-class expertise in data analysis should not have faced the biggest health crisis in a hundred years with virtually no data to analyse.” The Report also criticized delays in implementing lockdowns, failure to follow emerging international best practices, and the “slow, uncertain, and often chaotic performance of the test, trace and isolate system,” which “…ultimately failed in its stated objective to prevent future lockdowns despite vast quantities of taxpayers’ money being directed to it.” The country’s “lack of priority attached to social care during the initial phase of the pandemic was illustrative of a longstanding failure to afford social care the same attention as the NHS,” and “…led to many thousands of deaths which could have been avoided.”
In addition, the Report noted the impact of structural inequality on the pandemic response, saying that it “underlines the need for an urgent and long term strategy to tackle health inequalities and to address the working conditions which have put staff from Black, Asian and minority ethnic communities at greater risk,” and that “…disproportionately high mortality rates that people with learning disabilities and autistic people have suffered throughout the pandemic has highlighted the health inequalities faced by this group.”
The Report also cited areas where the country’s response outperformed those of other countries, such as its recognition of the importance of, and investment in vaccines, and the strategy it used to deploy them and the country’s research on treatments for COVID-19. Source
• Thailand plans to implement a phased strategy to reopen; as of 1 November, the country will allow fully vaccinated travelers (who undergo before departure and upon arrival) from ten low-risk countries, including the United States and China, to avoid quarantine. Source
• J & J and Moderna submitted documents to the US FDA supporting emergency use authorization of their coronavirus boosters. J & J argued that a booster increased protection against COVID-19, including against severe illness, and strengthened immune responses against variants and could be given as soon as two months after the first dose, although a six-month interval produced more robust immune responses.
Moderna argued for a half-dose booster of its coronavirus vaccine to prevent infection and mild to moderate COVID-19, claiming “real world evidence of reduced effectiveness against the Delta variant, although, according to the FDA, study results on the vaccine’s durability and efficacy against the Delta variant differ. Moderna noted that a booster increased the mean antibody levels among study participants by 1.8 times, and that the booster quadrupled levels of neutralizing antibodies among 87.9 percent of recipients (narrowly failing to meet the agency’s requirement of 88.4 percent). Source
• Some countries are shifting from incentivizing coronavirus vaccines to mandating them, including France, where unvaccinated people must pay for testing (which enables them to eat indoors among other privileges); Italy, where at least one dose of a coronavirus vaccine (or proof of recovery from COVID-19, or a negative test) are required to work in shops, restaurants, offices and factories; Greece, where unvaccinated people are prohibited from sitting inside bars and restaurants where transmission rates are high, and several US cities – and, if President Biden is successful, private employers will impose vaccine mandates despite powerful opposition from republicans. Source
• In India, where 29 percent of the country’s 944 million adults have been fully vaccinated, the Central Drugs Standard Control Organisation and Subject Expert Committee have recommended emergency use of Bharat Biottch’s coronavirus vaccine for children and adolescents ages 2 to 18 years. Other Indian vaccine producers, Serum Institute and Biological E, are conducting trials in young children. Source