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“This positive interim analysis of the third phase of the test gave us the first clinical confirmation that our vaccine can prevent covid-19 disease, including the severe form,” said Stephane Bancel, CEO of Moderna. He also thanked all employees, business partners and test participants, the Modern press release writes.
The effectiveness of the vaccine was demonstrated by the intermediate results of the third phase of clinical trials, in which more than 30,000 people participated. The first results were prepared based on an analysis of 95 participants who contracted covid-19. Of those, 90 received a placebo and five received a vaccine, they said.
The results showed a total of 11 cases of severe disease, all in the placebo group. These have not yet been verified by independent experts, according to the French news agency AFP.
The company added that 9.7% of people experienced fatigue as a side effect after receiving the second dose of the vaccine, 8.9% experienced muscle pain, 5.2% experienced joint pain, and the 4.5% had a headache. . These side effects were generally short-lived, they pointed out.
Preliminary analysis shows that the vaccine is safe and effective in all subgroups involved, they added.
They plan to apply to the US Food and Drug Administration (FDA) for emergency vaccine approval in the coming weeks, Moderna added. This authorization should be based on a final analysis of 151 cases and a median follow-up of more than two months.
The mRNA-1273 vaccine is based on informational ribonucleic acid (mRNA). It conveys instructions that stimulate the body’s cells to make proteins to prevent or fight disease.
Long-term transportation and storage will be possible for up to six months at -20 degrees Celsius, which are standard temperatures in home and medical freezers. Within this semester it will be possible to store the vaccine in the refrigerator for up to 30 days, ie. at a temperature between two and eight degrees Celsius. At room temperature, however, it can take up to 12 hours, the US pharmaceutical company explained.
This is, in the words of Juan Andres, Moderna’s technical director and quality director, “a significant advance that would make distribution easier and more flexible to facilitate large-scale vaccination in the United States and other parts of the world.”
By the end of the year, the United States plans to provide approximately 20 million doses of the vaccine. Next year, they plan to produce another 500 million to one billion doses worldwide.
The European Medicines Agency (EMA) announced today that it has started checking early data on Moderna with respect to covidu-19. This is a so-called ongoing exam, which is meant to quickly evaluate a potential drug or vaccine during a health crisis. This procedure allows you to review data on an ongoing basis while clinical trials are still ongoing.
He previously initiated this process for a vaccine developed by the German biotechnology company BioNTech and the American pharmaceutical giant Pfizer, and a vaccine developed by AstraZeneca and the University of Oxford.
If Modern’s vaccine is 94.5% effective in the general population, it will be one of the most effective vaccines in existence. It’s comparable to the measles vaccine, which is 97 percent effective, AFP reports.
BioNTech and Pfizer, meanwhile, are 90% effective and the Russian Sputnik V is 92% effective.
Reactions to the news of the Modern vaccine are already raging from around the world. The World Health Organization (WHO) has announced that this is rather encouraging news.
WHO chief scientist Soumya Swaminathan stressed that more data was needed. As he said at a press conference in Geneva, test participants need to be monitored for another two months for possible side effects.
“Many questions remain,” regarding both Moderna’s vaccine and rival Pfizer’s, which has also proven very effective in experimental clinical trials, Swaminathan added. According to her, more knowledge is needed on how long these vaccines protect against the new coronavirus, to what extent they prevent more severe forms of covida-19 and what impact they have on the elderly, reports the German news agency dpa.
WHO’s first man, Tedros Adhanom Ghebreyesus, also said in response that it was encouraging news, but at the same time he expressed concern about the rise of new infections in many countries. He also warned that it was not yet the time for complacency, reports the French news agency AFP.
In the United States, both newly elected President Joe Biden and current US President Donald Trump responded via Twitter. Biden accompanied the news with words that inspire hope, but at the same time called for further compliance with protective measures, such as social distancing and the use of protective masks.
Trump, on the other hand, tried to attribute the success for the breakthrough to himself. “Please remember that these great discoveries that will end the Chinese plague occurred when I was in position.”
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