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CAMBRIDGE, Massachusetts: Moderna said it will apply for emergency authorization from the US and Europe of its COVID-19 vaccine on Monday (Nov 30) based on the full results of a late-stage study showing that its vaccine was 94 , 1 percent effective without serious safety concerns. .
They also reported a 100% success rate in preventing severe cases. The filing states that Moderna’s product will be the second vaccine likely to receive emergency use authorization from the United States this year.
“We think we have a vaccine that is very effective. Now we have the data to prove it,” Dr. Tal Zaks, Moderna’s chief medical officer, said in a telephone interview. “We hope to play an important role in reversing this pandemic.”
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Zaks said he was excited after seeing the 94.1 percent result over the weekend: “It was the first time I allowed myself to cry. At this level of effectiveness, when you just do the math on what it means for the pandemic. that is ravaging us, it is just overwhelming. “
Moderna’s announcement follows news from Pfizer and German partner BioNTech that their vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95 percent effective. Pfizer has applied for the emergency use authorization, placing it about a week before Moderna.
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In addition to filing its application in the US, Moderna said it would seek conditional approval from the European Medicines Agency, which has already begun an ongoing review of data, and will continue to speak with other regulators conducting ongoing reviews.
Moderna’s latest efficacy result is slightly lower than an interim analysis published Nov. 16 of a 94.5 percent effectiveness, a difference Zaks said is not statistically significant.
Both the Moderna and Pfizer vaccines were shown to be more effective than anticipated and well above the 50 percent guideline set by the US Food and Drug Administration.
Britain’s AstraZeneca has announced an average efficacy rate of 70 percent for its vaccine and up to 90 percent for a subset of trial participants who received half the dose first, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90 percent efficacy figure for the smaller group.
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Still, recent weeks of positive vaccine results have sparked hopes that a pandemic that has hit economies and claimed more than 1.45 million lives worldwide will end. It occurs when new infections and hospitalizations for COVID-19 are at record levels in the United States.
Independent advisers from the US Food and Drug Administration will meet on December 17 to review data from Moderna’s trial and make a recommendation to the FDA. They will meet on December 10 to review the Pfizer data.
Shortly after obtaining emergency use authorization, Moderna expects the vaccine to be shipped to designated distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a government-contracted drug distributor. from United States.
It is expected to be easier to distribute than Pfizer’s because, while it must be stored in a freezer, it does not require the ultra-cold temperature that Pfizer’s vaccine requires.
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100 PERCENT SUCCESS RATE IN SERIOUS CASES
Of the 196 volunteers who contracted COVID-19 in the trial of more than 30,000 people, 185 had received a placebo versus 11 who received the vaccine. The company reported 30 severe cases, all in the placebo group, meaning the vaccine was 100 percent effective in preventing severe cases. The trial included one COVID-19-related death in the placebo group.
Moderna said the vaccine’s efficacy was consistent based on age, race, ethnicity and gender demographics. The 196 cases included 33 adults over the age of 65 and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans, and 3 multiracial participants.
Zaks said the vaccine was developed during a period of “political acrimony” and having a highly effective vaccine can go a long way toward erasing some of that mistrust.
“This is as black and white as the effect will be in a population. The chances of being really sick if you have been vaccinated are reduced 20 times,” he said.
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Moderna reported no new side effects since its interim analysis on Nov. 16. According to that analysis, the most common side effects were fatigue, injection site redness and pain, headache, and body aches, which increased after the second dose and were short-lived.
Zaks said the vaccine caused flu-like symptoms in some participants, which, he said, “goes hand in hand with having such a powerful vaccine.” But so far it hasn’t caused any significant security problems.
Moderna plans to begin a new trial to test the vaccine in adolescents before the end of the year, followed by another trial in even younger volunteers in early 2021. The company hopes to have the vaccine available for adolescents in September of next year, Zaks said. .
Other vaccine manufacturers have said they are studying their vaccines in young people as well.
Moderna said it was on track to have about 20 million doses of its vaccine ready to ship to the United States by the end of 2020, enough to inoculate 10 million people.
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