Research Roundup: AU, CEPI partner to boost African vaccine manufacturing, Regeneron seeks EUA for preventative therapy, and researchers investigate rare blood clots
Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.
The Africa Centers for Disease Control and Prevention, African Union Commission, and Coalition for Epidemic Preparedness Innovations have announced a partnership to enhance vaccine research, development, and manufacturing in Africa. The agreement, announced following a two-day virtual conference on African vaccine manufacturing, will seek to strengthen the COVID-19 response and outbreak preparedness, build on key lessons from COVID-19, and leverage the successes of procurement and distribution of vaccines by COVAX and the African Vaccine Acquisition Task Team. Through the initiative, the partner institutions also intend to invest in capacity strengthening and innovations to accelerate vaccine production, strengthen African scientific institutions, and build partnerships that enable sustainable expansion of vaccine manufacturing in Africa.
Regeneron plans to request an expanded emergency use authorization from the US Food and Drug Administration for its COVID-19 antibody cocktail after new data indicated it can prevent disease in healthy individuals. In a phase 3 trial run jointly with the National Institutes of Health, the antibody therapy cut the risk of developing symptomatic COVID-19 by 81 percent among healthy individuals who lived with an infected person. The antibody cocktail is currently authorized as an intravenous infusion to minimize disease progression in sick patients; the new request would allow the drug to be administered as a single-dose subcutaneous injection and used as a preventative measure. If authorized, the antibody cocktail could play a practical role in COVID-19 protection measures, including after high-risk exposures and in immunocompromised individuals who may not respond well to vaccines, according to a company statement.
Amid reports of rare blood clot–related side effects among individuals who received COVID-19 vaccines developed by AstraZeneca and Johnson & Johnson, researchers are investigating whether and how the vaccines are causing this adverse reaction. Two papers published in the New England Journal of Medicine described 16 patients who experienced this cerebral venous sinus thrombosis, tied to the AstraZeneca vaccine, and offered a partial explanation for a potential link, finding blood clots were seen in conjunction with high levels of antibodies to platelet factor 4. The finding provides a first step toward explaining the extremely rare side effect but does not explain why a vaccine might cause the immune system to produce those antibodies. Researchers plan to continue investigating the reaction, assessing the data, and monitoring cases alongside regulatory authorities.