Phoenix Inc. and Biotech may seek emergency US and European authorization for their Kovid-19 vaccine next month, after mammograms said Wednesday that the final trial results showed a 95% success rate and no serious side effects.
The effectiveness of the vaccine has been found to be consistent across different ages and races – a sign of hope given the disease has disproportionately hurt the elderly and some groups, including black people.
Biotech chief executive Ugur Sahin told Reuters TV that the US Food and Drug Administration could issue emergency-use in mid-December. He said conditional approval could be obtained in the European Union in the second half of December.
“If everything goes well, we could get approved in the second half of December and start deliveries before Christmas, but only if everything goes positive,” he said.
The vaccine success rate developed by US drug maker and German partner Biotech is higher than what regulators have said is acceptable. Experts say this is a significant achievement in the race to end the epidemic.
Of the 170 volunteers who contracted Kovid-19 in Pfizer’s trial involving more than 43,000 people, 162 had received a placebo and not a vaccine, meaning the vaccine was 95% effective. One in 10 people with severe Covid-19 had been vaccinated.
“The first in the history of mankind: less than a year from the virus sequence to the large-scale clinical trial of the vaccine, and based on a whole new strategy,” said Enrico Bukki, a biologist at Temple University in Philadelphia. “Today is a special day.”
Biotech’s Sahin said the application for the U.S. Emergency Use Authority (EUA) will be filed on Friday.
The FDA Advisory Committee plans to meet temporarily on December 8-10 to discuss the vaccine, a source familiar with the situation said, though dates may change. The FDA did not respond to requests for comment.
Kovid-19 Runs Rampant
The final trial analysis comes a week after the initial results showed that the vaccine was more than 90% effective. Moderna Inc. released preliminary data Monday showing a 94.5% effectiveness for its vaccine.
“We now have two safer and more effective vaccines that can be authorized by the Food and Health Administration and ready to be delivered within weeks,” US Secretary of Health and Human Services Alex Azar said.
US officials said Pfizer could authorize the Moderna vaccine within seven to 10 days of receiving its EUA, with states ready to begin delivery within 24 hours.
Better results than expected from two vaccines developed with new messenger RNA (mRNA) technology have sparked hopes of ending the epidemic that has killed more than 1.3 million people and has wreaked havoc on the economy and everyday life.
The news that the virus is once again spreading across the globe is especially welcomed, with new infections and hospitals building records every day.
The Pfizer-Biotech Shot has a 94% efficacy in people over 65 years of age, especially in the high-risk group.
“This is the evidence we need to make sure that the most vulnerable people are protected,” said Andrew Hill, a senior visiting research associate at the Department of Ethnology at Liverpool University.
Global stocks soared as experimental results raised concerns over rising infection rates. Pfizer shares are up 1.6% and Biotech is up 3.8% in the United States. Moderna shares fell 3.6%.
Investors view vaccine development as a race between companies, although there is a global demand for vaccines to be produced for the foreseeable future.
Delivery shots
Pfizer is expected to make a vaccine of 50 million this year, enough to protect 25 million people, and then produce 1.3 billion doses in 2021.
Although some groups, such as health workers, prefer vaccinations in the United States and Britain, it takes months for large roll outs to begin in both countries.
Pfizer said on Wednesday that it would offer Brazil millions in the first half of 2021. It has contracts with the European Union, Germany and Japan, where delivery could begin next year.
Mike Ryan, a top Emergency Specialist at the World Health Organization, said it would take at least 4-6 months for significant vaccinations to occur worldwide.
The distribution of the Pfizer-BioTech shot is complicated by the need to store at ultra-cold temperatures of -70 ° C. However, it can be kept in a thermal shipping box for five days or 15 days under normal refrigeration.
Modern vaccine can be stored for up to six months at -20C, but it is expected to remain stable for 2 to 8 degrees Celsius (36 ° -46 ° F) for 30 days at normal fridge temperatures.
Fatigue and headaches
Pfizer said the vaccine was well tolerated and the side effects were often mild to moderate and quickly cleared. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headache (2%) after the second dose. Older adults tended to report fewer and mild adverse events.
“These are exceptional results, and safety information looks good,” said David Spiegelhalter, a professor at Cambridge University and an expert in risk and proof communication.
Among the dozens of drug manufacturers and research groups competing to develop the Covid-19 vaccine, the next final step may come from AstraZeneca plc with Oxford University in November or December. Johnson and Johnson said they are on track to deliver data this year.
Vaccination of vaccines for children takes much longer. Pfizer has only begun vaccinating volunteers under the age of 18 and under 12 years old. Moderna and J&J say they hope to start vaccination testing on younger people soon.

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