nuttapong punna/istock via Getty
Pfizer’s COVID-19 Vaccine, Pneumococcal Vaccine Helps Older Adults
Pfizer recently announced positive top-line results from a Phase 3 trial studying its COVID-19 vaccine combined with its pneumococcal 20-valent conjugate vaccine, Prevnar 20.
Pfizer recently announced positive top-line results from a Phase 3 trial studying its COVID-19 vaccine combined with its pneumococcal 20-valent conjugate vaccine, Prevnar 20.
The study, B74710126, enrolled 570 adults aged 65 and older in the US who received their second dose of a COVID-19 vaccine at least six months prior to the study. Patients were given the Prevnar 20 either with the Pfizer-BioNTech COVID-19 vaccine or with a placebo.
Researchers found that Prevnar for all 20 stereotypes were similar whether given with a dose of the COVID-19 vaccine or with a placebo. In addition, the safety profile of co-administering Prevnar 20 with a booster dose of the COVID-19 vaccine was similar to the one observed with the booster dose.
“These new safety and immunogenicity data provide further evidence supporting the potential to administer PREVNAR 20 and the Pfizer-BioNTech COVID-19 Vaccine at the same time, thereby reducing the number of visits adults make to their doctor’s office or pharmacy for recommended immunization,” Kathrin U. Jansen, PhD, senior vice president and head of vaccine research & development at Pfizer, said in the announcement.
“As the COVID-19 vaccines and booster doses continue to be administered, we believe that healthcare providers have an opportunity to talk to their adult patients about other recommended vaccines in line with CDC guidance,” Jansen continued.
Prevnar 20 is a next-generation pneumococcal vaccine that includes capsular polysaccharide conjugates for the 13 serotypes.
The vaccine contains the broadest conjugate serotype coverage and helps protect against more strains of the bacteria that cause pneumococcal pneumonia than any other conjugate vaccine available.
FDA approved Prevnar 20 in June 2021 to prevent pneumonia in adults 18 years and older.
Pfizer will present and publish detailed outcomes from the B74710126 trial at a later date. Therefore, noNo co-administration data are included in the Prevnar 20 or Pfizer-BioNTech COVID-19 Vaccine prescribing information at this time.
Govt to Purchase 600,000 More Doses of GSK, Vir COVID-19 Treatment
GSK and Vir Biotechnology recently announced that the US government will purchase an additional 600,000 doses of their COVID-19 antibody treatment, sotrovimab.
The government will deliver the additional doses throughout the first quarter of 2022. The recent agreement also includes an option for the government to purchase further additional doses in the second quarter of 2022.
So far, GSK and Vir Biotechnology have received binding agreements to sell nearly 1.7 million doses of sotrovimab globally.
“We are proud to continue to work with the US government to bring sotrovimab to patients who need it, especially as the Omicron variant continues to grow in prevalence across the country,” Maya Martinez-Davis, president of US pharmaceuticals at GSK, said in the announcement.
“We understand the role we can play in supporting the ongoing pandemic response, and our teams are working with urgency to explore options to expand our supply capacity so we can support more patients in 2022,” Davis continued.
FDA granted emergency use authorization to sotrovimab in May 2021. And in June, the antibody reduced the risk of all-cause hospitalization for more than 24 hours or death by 79%.
Novavax Files for EUA of COVID-19 Vaccine in South Africa
Novavax and the Serum Institute of India recently filed for emergency use authorization of Novavax’sNovavax’s COVID-19 vaccine in South Africa.
The submission for the regulatory evaluation of the vaccine to the South African Health Products Regulatory Agency (SAHPRA) included data from two pivotal Phase 3 clinical trials, PREVENT-19 and a separate trial published in the New England Journal of Medicine.
The PREVENT-19 trial enrolled nearly 30,000 participants in the US and Mexico. The second trial enrolled 15,000 participants in the UK. The vaccine was highly effective with a reassuring safety profile in both trials.
Additionally, very few serious and severe adverse events were reported between the vaccine and placebo groups.
“Novavax is thankful for our long-standing history of partnership in South Africa to advance much-needed vaccines. This is exemplified by the country’s vital role in the Phase 2b clinical trial and booster study of our protein-based COVID-19 vaccine,” Stanley C. Erck, president and chief executive officer at Novavax, said in the announcement.
Novavax and the Serum Institute of India stated that they will remain focused on delivering the COVID-19 vaccine where it is needed most.