The US Food and Drug Administration (FDA) on Tuesday released an analysis calling the COVID-19 vaccine developed by US drug maker Moderna “very effective”. Authorities are expected to approve the emergency use of the vaccine as early as Friday, according to media reports. It would be the second COVID-19 vaccine to be approved in the United States, following those from Pfizer and Germany’s BioNTech. New data showed that fewer people developed asymptomatic infections after the first dose of The Modena vaccine compared with the placebo group, or that the first vaccine that had an impact on asymptomatic infections helped suppress the virus’s stealth transmission, but more data were needed to confirm that. Merck also has better data than Pfizer on the effectiveness of its vaccines in preventing severe cases.
Less loading is suitable for rural hospitals
The report, written by FDA staff and the Modena team, analyzed the safety and efficacy of the vaccine. The independent panel will review the report and meet On Thursday to vote on whether to recommend that the F.D.A. approve the emergency use of the Modena vaccine, leaving the final decision to the authorities, in the same process that approved Pfizer’s vaccine last week. The New York Times and others quoted sources as saying authorities hope to grant emergency use authorization on Friday to ship an initial 6 million doses of the vaccine across the United States by the end of the week and start vaccinations early next week. Federal officials say the Modena vaccine will be shipped less than the Pfizer vaccine and is better suited to small hospitals in rural areas. Both use the same mRNA technology, but the Merck vaccine is not refrigerated as Pfizer, and is easier to transport, store and process.
94% are effective in preventing symptomatic infections
The FDA confirmed that Modena’s earlier data showed that its vaccine was 94.1 percent effective in preventing symptomatic infections. In a clinical trial involving 30,000 people, the report said the Modena vaccine was effective in participants of all ages, genders, races and even with long-term illness, with young people more effective than older people. The vaccine response rate was 95.6 per cent in the 18 to 64 age group and 86.4 per cent in the 65 and over age group. Modena’s clinical trial is only for people aged 18 or above, and the company’s current application is limited to this age group; The Pfizer study included 16 – and 17-year-olds.
Notably, new data cited in the report suggest that the first dose of The Modena vaccine may help reduce asymptomatic infections. The focus of current vaccines is on preventing disease, but it is still possible that the virus can hide in the nose of the recipient and infect others. In the Modena trial, 14 people tested positive for the virus after the first dose of the vaccine but showed no symptoms, compared with 38 asymptomatic infections in the placebo group, and the report made no mention of what happened after the second dose.
Experts: More data needed to reduce community communication
That means that in addition to protecting oneself from severe illness, vaccination could also reduce the spread of the virus in the community, Modena Chief executive Stephane Bancel said. However, experts stressed that more data was needed to confirm whether the vaccine had helped reduce transmission.
No link has been confirmed between the three who are suffering from paralysis
In terms of preventing severe cases, The Data from Modena are temporarily stronger than those from Pfizer. In the Modena trial, there were 30 severe cases in the placebo group and none in the vaccine group. That compares with 10 severe cases in Pfizer’s placebo and one in the vaccine group. The FDA stressed that the available data were insufficient to draw firm conclusions. Authorities said the Modena vaccine poses no particular safety concerns. Common side effects include pain, fatigue, headache and chills at the injection site, which usually subside within a day. There were no cases of severe allergies in the study. Three people in the vaccine group and one in the placebo group developed “Bell’s Palsy,” or temporary facial paralysis, which can be caused by viral infections and other causes. Pfizer has four similar cases. Studies over the years have failed to confirm a link between the condition and the vaccine, and the FDA said the available information was insufficient to determine cause and effect.
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