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According to “Bloomberg”.
Questions remain about the production, distribution and, most importantly, the performance and capacity of the vaccine itself, although the numbers look very promising, according to vaccinologists who spoke to Bloomberg.
“The main question is still relevant. Will the future tell us that the effectiveness of the vaccine is beneficial for the greatest number of people?” Said Michael Kinch, vaccine development expert and vice-president. associate board at Washington University in St. Louis.
In a remarkable scientific achievement – achieved without funding from the US vaccine accelerator known as “Warp Speed” – Pfizer and BioNTech achieved positive results just over 11 months after the emergence of Covid-19 in China .
On Monday, the same day the United States went through 10 million cases, the two companies said early analysis of data from the experiences of more than 40,000 volunteers indicated the vaccine was over 90% effective. to prevent disease.
The results were published in a press release and not in a periodic study reviewed by the partners. However, it sparked investor enthusiasm as stocks rose and bonds fell around the world. The Standard & Poor’s index closed at its highest level in two months, while travel and entertainment titles rebounded after months of epidemic damage.
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in a radio interview Monday that the two companies’ press release “doesn’t tell us at all what they actually accomplished. . It is too early to define what this new vaccine research is showing us. “
Igor Shaheen, CEO of BioNTech, said that about half of the trial participants are elderly, and it is possible that the current results show the degree of effectiveness in the elderly, which is expected to exceed 80%, adding: “It is necessary to analyze more to confirm this.”
On the flip side, William Gruber, vice president of Pfizer, said the current analysis of the data does not include serious cases, but should occur as the study continues. .
Pfizer expects to have cumulative safety data for two months by next week, and if there are no unexpected issues, the company can apply for emergency use authorization for treatment with United States and society can get it by the end of November.
The emergence of the vaccine
After obtaining the emergency use permit, internal data audits will begin by the FDA, and the agency has promised outside expert review to increase public confidence in any vaccine that will be authorized.
In the event that emergency clearance is granted, a second committee of external experts convened by the CDC will determine the importance of the vaccine and who should receive it first, and then distribution will begin.
All of this means that even with the Pfizer data in place, it could be late December or even early January before a vaccine becomes available. At this point, there could be around 50 million doses in the world, enough for 25 million people.
In an interview late last month, Richard Hatchett, CEO of the Alliance for Pandemic Preparedness Innovations, said that if a vaccine crosses the line, there may be doubts about the sustainability of protection and how often. at which people may need booster doses. It is also possible that the number of available doses is not clear. He said global vaccine supplies could start to catch up with demand at some point in 2022.
“Even if we get a positive reading and a very benign safety indication and the emergency use authorization is extended – if that is what ends up happening in the United States – the amount of vaccine that will become available will remain limited, ”he said.
According to Irfinity Ltd., a London-based research company, World Speed’s efforts to develop and purchase vaccines must be successful – 6 out of 6 – for the United States to achieve herd immunity by now. June.
Failures and delays could extend the time frame to slow the spread of the virus until 2023 or later.
She added that vaccines must be stored at extremely cold temperatures, a challenge that must be overcome if the vaccine is widely deployed.
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