Amidst rising cases of coronavirus, US firm Moderna has given people some hope for the COVID-19 vaccine. The company said it will apply for the US and European emergency authorization of its vaccine on Monday based on full results from a late-stage study that shows strong protection against novel coronavirus.
In a statement, the company said, “A continuous review of safety data is ongoing and no new serious concerns have been identified by the experts. Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%. Moderna has planned to request EUA from the U.S. FDA, to apply for conditional marketing authorization with the European Medicines Agency (EMA), and to progress with the rolling reviews, which have already been initiated with international regulatory agencies.”
We just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, our COVID-19 vaccine candidate and that today, we plan to request an Emergency Use Authorization from the U.S. FDA & conditional approval from the EMA. Read more: https://t.co/90FbcVHdWN pic.twitter.com/36tpY0QeFl
— Moderna (@moderna_tx) November 30, 2020
Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
The statement also said the vaccine’s efficacy was consistent across age, race, ethnicity, and gender demographics. The 196 cases included 33 adults over 65 and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans, and 3 multiracial participants.
The British government has already secured millions of doses of the Moderna coronavirus vaccine and is expecting that 3.5 million people will be able to get vaccinated.
“The UK was one of the first countries in Europe to sign a deal with Moderna, and I’m delighted we have been able to secure further 2 million doses of their promising candidate for the British public,” Business Secretary Alok Sharma said as quoted in the government release. According to the statement, the new deal, signed on Sunday, brings the total number of Moderna vaccine doses secured for the UK to 7 million.
Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50 per cent benchmark set by the U.S. Food and Drug Administration.