Research Roundup: WHO issues recommendation for drugs to treat severe COVID-19, chikungunya vaccine candidate receives FDA breakthrough designation, and Pfizer plans to seek authorization for booster doses
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Last week, the World Health Organization (WHO) recommended the use of interleukin-6 receptor blockers as a treatment for severe and critical COVID-19, making these only the second set of drugs it has deemed effective in treating the disease. The interleukin-6 blocking drugs, tocilizumab and sarilumab, showed efficacy in reducing deaths in data from more than 10,000 patients involved in 27 clinical trials. Tocilizumab, made by Roche under the brand name Actemra, and sarilumab, made by Regeneron and Sanofi under the brand name Kevzara, are monoclonal antibodies used to suppress overreactions of the immune system in patients with severe COVID-19. In its recommendation, WHO also emphasized a need for equitable access to the treatments, calling on manufacturers to reduce the drugs’ prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging.
A chikungunya vaccine candidate developed by Valneva has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The single-dose, live-attenuated vaccine, VLA1553, also received FDA Fast Track designation in December 2018 and European Medicines Agency PRIME designation in October 2020. Valneva’s phase 3 trial to evaluate immunogenicity and safety of VLA1553 at 28 days following immunization completed recruitment in April, and top-line data is expected in the summer. The Breakthrough Therapy Designation is meant to facilitate and expedite development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates the drug may have substantial improvement for at least one endpoint over available therapies.
Pfizer intends to seek FDA authorization for a third dose of its COVID-19 vaccine in August, the company said Thursday, claiming another shot within 12 months could boost immunity and help combat virus variants. Early data from Pfizer’s booster study showed participants’ antibody levels jumped five- to ten-fold after a third dose, compared to their second dose months earlier. Research has also shown the current vaccine regimen offers strong protection against the delta variant, which is now spreading rapidly around the world and accounts for the majority of new US infections. On the same day as Pfizer’s announcement, the US Centers for Disease Control and Prevention and FDA issued a joint statement saying fully vaccinated Americans don’t need a booster shot yet, and any decision on boosters would happen only when “the science demonstrates that they are needed.”