Research Roundup: Novavax and CureVac release vaccine efficacy data, Regeneron antibody cuts deaths in some hospitalized patients
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Novavax’s COVID-19 vaccine showed 90 percent efficacy in preventing laboratory-confirmed symptomatic infection among adults aged 18 and older, according to phase 3 trial results released last week. The vaccine was also 91 percent protective in high-risk populations, 93 percent protective against variants of concern and variants of interest, and completely protective against hospitalization and death due to COVID-19. The recombinant protein vaccine is given in two doses, three weeks apart, and can be stored at refrigerator temperatures. Novavax plans to file for authorization with several drug regulators, including the US Food and Drug Administration (FDA), in the third quarter and expects to be able to produce 100 million doses a month by the end of that quarter followed by 150 million per month by the end of the year. Novavax also has an agreement with Gavi, the Vaccine Alliance, to deliver 1.1 billion doses of its vaccine, once authorized, to the COVAX vaccine-sharing facility.
In new data from the UK Recovery Trial, Regeneron’s antibody cocktail reduced the chance of death among hospitalized COVID-19 patients who haven't produced their own antibody responses to the disease. The study showed REGEN-COV reduced risk of death by 20 percent among seronegative participants, or those who produced no natural antibody response, while for patients who had developed antibodies, the treatment didn't work at all. Among the seronegative group, the treatment also reduced the average hospital stay by four days and decreased the chance of a patient requiring a ventilator. REGEN-COV received emergency use authorization from the FDA late last year for patients with mild to moderate COVID-19 and recently received an expanded green light for a lower dose and delivery by subcutaneous injection. Regeneron now intends to take the new data to the FDA for expansion to use in seronegative hospitalized patients.
CureVac’s two-dose mRNA COVID-19 vaccine was 47 percent effective against COVID-19 disease of any severity among participants in a 40,000-person trial, interim analysis shows. The broad diversity of variants makes it challenging to demonstrate high efficacy, according to a statement from CureVac’s chief executive—13 variants were recorded in the trial, with only a single case caused by the original SARS-CoV-2 virus. More than half of the cases were infections with variants of concern. The trial, conducted in ten countries in Latin America and Europe, will continue, and final data is expected in the coming weeks. The CureVac vaccine is of most importance to the European Union, which has preordered 225 million doses, with the option to buy 180 million more.