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NIH Launches COVID Variant Trial; Pfizer Releases New Data
In other COVID-19 vaccine news, J&J is on track to meet its vaccine distribution goal and GSK will help Novavax manufacture its vaccine.
NIH recently announced that it has started a Phase 1 clinical trial of Moderna’s variant-specific COVID-19 vaccine candidate, mRNA-1273.351.
Researchers will evaluate the safety and reactogenicity of mRNA-1273.351, as well as its ability to induce an immune response, in 210 healthy adult volunteers at four clinical research sites in the US.
The trial will also enroll 150 volunteers aged 18 to 55 years who have not received any COVID-19 vaccine, have no known history of SARS-CoV-2 infection, and do not have health conditions that are associated with an increased risk of severe illness.
The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the US.
In December 2020, Moderna announced that its vaccine COVID-19 vaccine candidate, mRNA-1273, elicited a vaccine efficacy of 94.1 percent.
Moderna’s FDA-approved mRNA-1273 differs from mRNA-1273.351 in that it delivers instructions for making the SARS-CoV-2 spike that incorporates key mutations in the B.1.351 virus variant, NIH explained.
Volunteers in the trial will provide blood samples at specified times, which will be used to measure the immune response against circulating strains of SARS-CoV-2, including B.1.351.
“Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine,” NIAID Director Anthony S. Fauci, MD, said in the announcement.
Pfizer, BioNTech Confirm High Efficacy of COVID-19 Vaccine
Pfizer and BioNTech recently announced that their COVID-19 vaccine, BNT162b2, was 91.3 percent effective against the coronavirus in a Phase 3 study.
The Phase 3 study enrolled 46,307 trial participants, of which 927 had confirmed symptomatic cases of COVID-19. Nearly 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group.
Thirty-two cases of severe disease were observed in the placebo group versus none in the BNT162b2 vaccinated group. This indicates that BNT162b2, by CDC and FDA definition, was 100 percent and 95.3 effective against severe disease, respectively.
Notably, no serious safety concerns were observed in trial participants up to six months after the second dose. Side effects were generally consistent with previously reported results.
Ugur Sahin, CEO and co-founder of BioNTech explained that the data provide the first trial results that a vaccine can effectively protect against currently circulating SARS-CoV-2 variants.
Johnson & Johnson to Complete Full Vaccination in Over 20M US Citizens
Johnson & Johnson recently announced that it has met its commitment to deliver enough single-shot vaccines by the end of March to fully vaccinate more than 20 million people in the US.
The company stated that it will continue to run tests and complete quality checks to ensure manufacturing is validated and the end product meets the highest quality.
At the beginning of March, FDA authorized Johnson & Johnson’s single-dose COVID-19 vaccine candidate based on Phase 3 data. The data showed that the vaccine was 67 percent effective in preventing moderate-to-severe coronavirus 14 days after vaccination.
Johnson & Johnson’s update on vaccination delivery status is in line with its expectation to deliver its vaccine at a rate of more than one billion doses by the end of 2021.
GSK Supports Manufacturing of Novavax COVID-19 Vaccine
GSK recently reached an agreement with Novavax and the UK Government Vaccine Taskforce to support manufacturing of up to 60 million doses of Novavax’s COVID-19 vaccine candidate for use in the UK.
GSK will provide “fill and finish” manufacturing capacity beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately.
Fill and finish is the completion stage of vaccine manufacturing, preparing vials of the final vaccine and packaging them for distribution and use, GSK explained.
