Moderna, Inc. announced that updated cases in its trial show its COVID-19 Vaccine (mRNA-1273) is greater than 90% effective against all cases of COVID-19, with around 6 months median follow-up post-dose 2. The new data from the Phase 3 COVE Study also shows that the vaccine is greater than 95% effective against severe cases of COVID-19.
The company added that new preclinical data shows variant-specific booster vaccine candidates (mRNA-1273.351 and mRNA-1273.211) increase neutralizing titers against SARS-CoV-2 variants of concern.
Further, Moderna said it delivered approximately 132 million doses globally as of April 12. For the first quarter of 2021, the company delivered approximately 88 million doses to the U.S. government and approximately 14 million doses to other customers.
Moderna remains on track to deliver the second 100 million doses to the U.S. government by end of May 2021 followed by another 100 million additional doses by end of July 2021.
In its clinical update on the COVID-19 Vaccine program ahead of 2nd annual vaccines day on Wednesday, the biotechnology company said an updated review of adjudicated cases has identified over 900 cases of COVID-19 in the COVE study as of April 9, including over 100 cases of severe COVID-19, as defined in the protocol, with a median follow-up of approximately 6 months post-dose 2.
Vaccine efficacy starting two weeks following the second dose and based on the updated adjudicated cases remains consistent with prior updates.
As of April 13, all placebo participants have been offered the Moderna COVID-19 Vaccine and 98% of those have received the vaccine.
The COVE study is ongoing and reported results to remain preliminary. Moderna said it will share updated data from the Phase 3 COVE study throughout the year.
Regarding its Phase 2/3 TeenCOVE study of mRNA-1273 at the 100 µg dose level in adolescents ages 12-17, the company said the trial is fully enrolled with approximately 3,000 participants in the U.S. The company expects to enroll 6,750 healthy pediatric participants in the U.S. and Canada into this two-part, dose-escalation study.
Regarding blood clots or Cerebral Venous Sinus Thrombosis or CVST, the company noted that an assessment of its vaccine after over 64.5 million doses administered globally does not suggest an association with CVST or thrombotic events.
Following reports of blood clots, the U.S. Food and Drug Administration Tuesday halted the use of Johnson & Johnson’s Covid-19 vaccine temporarily.
AstraZeneca’s COVID-19 vaccine also had faced block following reports of blood clots. However, the European Medicines Agency last week said blood clots are a “very rare” side effect of the vaccine, and that its benefits continue to outweigh its risks.
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