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On Monday, Pfizer announced in a press release that its coronavirus vaccine candidate was more than 90% effective in preventing COVID-19 in study participants. News from America’s largest pharmaceutical company, which works in partnership with German company BioNTech, came just as the United States was experiencing a record number of cases of the deadly virus and sparked a wave of celebrations – stocks jumped, the Trump camp presented it as a victory and Dr Anthony Fauci, a leading infectious disease specialist, called the results “extraordinary.”
Previously, Fauci and the Food and Drug Administration had said that a coronavirus vaccine that protected 50-60% of the population would have been acceptable, so 90% efficacy represents “light at the end of the tunnel,” as the CEO of Pfizer, Dr. Albert Bourla told MSNBC. But there are still some important unknowns.
Pfizer’s press release does not include the two months of safety data required by the FDA before companies can apply for emergency use authorization; Pfizer says it should have it next week. The company’s Phase III clinical trial began in July and enrolled 43,538 participants, including about 30 percent of US participants from “diverse racial and ethnic backgrounds.” But beyond that, nothing has yet been made public about how participants from different demographic groups responded to the vaccine.
“We still don’t know much about the trial participants in terms of how they responded to the vaccine, side effects, other complications, comorbidities,” said Dr. Dara Kass, medical contributor to Yahoo News. “We will have more information when this data is released, so it is not time to overanalyze this press release. It’s just time to wait and be optimistic that a vaccine against this coronavirus is likely.
Information on how participants from different demographic groups – especially those who are most vulnerable not only to infection but also to complications of infection – will be important. Black, Hispanic, and Native American communities have been hit particularly hard by the coronavirus pandemic, so understanding how the vaccine affected trial participants in these groups will be critical. Information on trial participants from the vulnerable elderly population will also be crucial.
“We do not yet have information on the type of trial participants who were vaccinated and infected, or vaccinated and were not infected,” Kass said. “We need to know more about patients protected by vaccination. Was it the same for all demographics? “
If the vaccine is approved by the FDA, questions about how to distribute it will arise. The company said it plans to produce up to 50 million doses worldwide by the end of the year and up to 1.3 billion by 2021. But full immunity requires two doses, of so the number of people that can be treated will be half that amount. The CEO of Pfizer also said he was still not sure how long the vaccine was protected for. If it is an annual or seasonal vaccine, production will need to be further ramped up to meet demand each year.
The “very specific” requirements for handling this particular vaccine are also already frustrating for health officials. CNN reports that Pfizer’s vaccine must be stored at minus 75 degrees Celsius – about 50 degrees cooler than any vaccine currently in use in the United States – and doctors’ offices, pharmacies, and state labs don’t have freezers as low. Meanwhile, dry ice – which has been in high demand thanks to an increase in home food deliveries and a low supply due to the decrease in the production of carbon dioxide, a by-product of fuel combustion. fossils – could become a critical but difficult component to come in the distribution process.
“Not all of the quilt squares have been put together very squarely at this point,” a long-time CDC vaccine adviser told CNN about distribution issues. “There are probably more questions than answers.”
And even if these vaccine-related hurdles are overcome, will enough people take it? Willingness to receive a coronavirus vaccine was extremely low in a Yahoo News / YouGov poll conducted last month, especially among the African American community most at risk, with just 46% of white Americans and 27% of black Americans saying they would take one if it was available.
Pfizer’s eagerly awaited data release will be crucial in building public confidence that the vaccine is safe. But Kass explained that controlling the increase in cases, which could peak before a vaccine becomes available to the general population, should be our most immediate concern. The triad of handwashing, removal and mask-wearing precautions will remain in place for the foreseeable future.
“The most important thing to remember is that this information is not really changing our day-to-day lives right now,” Kass said of Pfizer’s announcement. “We are excited about the possibility of a vaccine, but we need to focus now on stopping the spread of this virus in our communities.
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