• US coronavirus cases surpass 44 million. Source
• Pfizer and its partner BioNTech announce that they have asked the US FDA to grant emergency use authorization for their coronavirus vaccine. for children ages 5 to 11, who number over 28 million. FDA has tentatively scheduled a meeting on 26 October, promising that it will move quickly.
FDA approval rests on data from clinical trials and whether the companies can prove that they are able to properly manufacture their new pediatric formulation. Pfizer has proposed a pediatric dose that is one-third of the adult dosage, which may call for require adding more diluent to each injection or using a different vial or syringe. The method for the pediatric formulation is expected to be included as part of the submission to FDA. Source
• Politico reports that the Biden administration has been pressuring Moderna (which received over eight billion dollars in government funding to develop its coronavirus vaccine), to increase donations of its shots in 2022 in meetings described as “very intense.” Moderna has cited concerns about balancing its domestic and international commitments, although administration officials think the company is reluctant to forgo profits by supplying urgently-needed vaccines at cost. “ We need them to step up to the plate in the short term and dramatically increase the number of doses they’re delivering to low-and middle-income countries. This is something the administration has been trying to get Moderna to commit to for a long time, “ said an unnamed senior official direct knowledge of the situation, adding, “It’s been difficult.”
Moderna recently announced that it will spend $500 million on an African mRNA vaccine hub, but it has not disclosed a timeline, and it could take years before the hub is functional – which will not help the Biden administration reach its goal of ending the pandemic by Q3 2022. The company has also refused yield to increasing pressure from activists and international organizations to share its vaccine formula so that it can be produced by manufacturers in other countries. Source
• Health authorities in France announce that unvaccinated people will have to pay for SARS-CoV-2 testing as of 15 October which is also the country’s deadline for mandatory vaccination for health care workers). Source
• Malaysia has purchased 150,000 courses of Merck’s experimental COVID-19 antiviral, molnupiravir. Source
• WHO has begun shipping COVID-19 medical supplies into North Korea through the Chinese port of Dalian. WHO is working with North Korean officials to facilitate delivery of coronavirus vaccines through COVAX, although the country claims it has not had a single case of COVID-19. North Korean leader Kim Jong Un has already turned down Sinovac vaccines offered by COVAX, saying they should be sent to severely affected countries instead. Source
• Pediatrics publishes a study reporting that over 140,000 children in the US lost a parent or grandparent to COVID-19 during the period between 1 April 2020 and 30 June 2021. The risk of caregiver loss was higher among children from racial and ethnic minorities than White children, affecting 1 of 412 Hispanic children, 1 of 310 Black children, and 1 of 168 American Indian/Alaska Native children, versus 1 of 753 White children. The authors note that children who lose a parent or caregiver are at higher risk of mental health problems, shorter schooling, lower self-esteem, abuse, unstable housing, household poverty and higher risk of suicide, sexual violence and exploitation, suggesting “…an immediate need to integrate care for children into COVID-19 Emergency Response priorities, which focus on vaccination, mitigation, testing, contact tracing, and disease management. The magnitude of COVID-19-associated parent and caregiver death suggests effective responses should combine equitable access to vaccines with evidence-based programs for bereaved children, focusing on areas with greatest disparities,” adding that “…provisions must be sensitive to racial disparities and structural inequalities, to reach the children that need them most. The success of these strategies, in the context of disparities, will hinge on engaging community-led initiatives that change the systems driving structural inequities.” Source
• Some countries- including Britain, Hong Kong, and Norway – have recommended a single dose of the Pfizer/BioNTech coronavirus vaccine for children ages 12 and older, because they are worried about heart inflammation, called myocarditis, a rare side effect, usually from the second dose of an mRNA vaccine, which occurs more frequently among young men. Source
• Finland halts rollout of the Moderna vaccine in men under age 30 over concerns about myocarditis, a rare cardiovascular side effect. Source
• UN Secretary General António Guterres, who seeks eight billion dollars to address global vaccine inequity for a new WHO strategy to ensure that 40 percent of the world’s population is vaccinated by the end of 2021, described the current coronavirus vaccine inequity as “…not only a question of being immoral — it is also a question of being stupid.” Source
• In August, Zydus Cadila received emergency use authorisation from India’s drug controller general for the first DNA-based coronavirus vaccine, ZyCoV-D, which is given in three doses without a needle. In a 28,000-person trial, the vaccine was 67% effective at preventing infection. India’s rollout – which will begin in adults although most doses have been earmarked for children – has been delayed by training and logistics issues. Source