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Original title: Moderna said that the confirmation of validity of the vaccine will be sent in Europe and the United States for authorization. Source: Sina US stocks
Ahead of the US stock market on Monday, the new crown shot brought other good news. American vaccine maker Moderna said that based on updated data from the phase III clinical trial, the new corona vaccine it developed is more than 94% effective and safe. It will submit an emergency clearance request to regulatory authorities in the US and Europe later on Monday.
The news sent Moderna’s pre-market share price up more than 11%. The positive news of the vaccine has caused the company’s share price to rise more than 93% in the last month. In the last five business days, the company’s stock price has risen more than 30%; this year, Moderna’s share price has risen nearly 550%.
Moderna has also become the second vaccine manufacturer after Pfizer to submit an emergency clearance application for the vaccine to the FDA. On November 20, Pfizer submitted an emergency vaccine authorization request to the FDA. The company said it is expected to get approval within a few weeks and to begin vaccinating priority groups.
Moderna’s updated clinical data analysis evaluated 196 confirmed cases of new corona infection among the 30,000 participants in the subsequent trial. The company said 185 subjects were seen to be infected with the new coronavirus in the placebo group, while only 11 cases were seen in the vaccine group. This means that, under optimal conditions, the vaccine effectiveness rate is expected to reach 94.1%.
Moderna also stated that the efficacy of the vaccine is constant according to age, race and gender. Among the 196 confirmed cases of infection, there are 33 adults over 65 and 42 blacks, Latinos and other minorities. The company said the vaccine is also well tolerated, with the most common side effects being fatigue, muscle pain, headaches, and pain at the injection site.
On November 16, the data published by Moderna was based solely on the analysis of 95 cases of new corona infection, and the results showed that its vaccine has an effective rate of at least 94%. Following the publication of the Moderna data, Pfizer also released updated data on the effectiveness of the vaccine, showing that the effectiveness of the vaccine can approach 95%.
Moderna’s data also shows that the vaccine appears to prevent serious diseases caused by infected subjects. Moderna said none of the 30 serious illnesses were in the vaccine group. Additionally, the company also said that in this study, one new corona-related death occurred in the placebo group.
“This positive preliminary analysis confirmed that our vaccine is 94.1% effective in preventing new coronary diseases. Most importantly, the vaccine also has the ability to prevent new serious coronary diseases.” Stephen Bansell (Stephane), CEO of Moderna Bancel—) said in a statement: “We believe that our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent hospitalizations and deaths caused by serious diseases. “
As of Sunday night, the new corona epidemic has killed at least 1.45 million people worldwide. The world hopes that the advent of vaccines can stop the spread of the virus and get the economy back on track.
The FDA review process for the vaccine is expected to take several weeks. After Pfizer submitted an emergency clearance request for the vaccine, the FDA stated that it would host an advisory committee meeting on December 10 to review the vaccine. Both Pfizer and Moderna said they will also submit an emergency authorization request for vaccines to the EU drug regulatory authority.
The Secretary of Health and Human Services of the United States, Alex Azar (Alex Azar), said on November 16 that the FDA will act as soon as possible to remove the barriers to the emergency approval of the Pfizer and Moderna vaccines. Azar also said that around 40 million doses of the new corona vaccine will be available by the end of this year, enough to vaccinate about 20 million people.
Public health officials and medical experts have noted that it is not yet clear how long the vaccine will provide immunity and if people need regular booster shots or for how long. Moderna and Pfizer’s vaccines are nucleic acid vaccines that use mRNA technology, a new vaccine method that uses genetic material to stimulate the human immune response, but has never been commercialized before.
In terms of storage conditions, Moderna’s vaccine is better than Pfizer’s. Moderna vaccine should only be stored at normal refrigerator temperature and can be stable for 30 days; whereas the Pfizer vaccine must be stored at minus 80 degrees Celsius and can only be stored at refrigerator temperature for 5 days.
But the price of the Moderna vaccine may be higher than Pfizer’s. The company previously disclosed that the vaccine charges for some customers ranged from $ 32 to $ 37 per dose, and that this price “has taken into account the antecedents of the new corona pandemic.” Also, the negotiated price for high-volume purchases may fall further.
