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In July, Pfizer and BioNTech began a late-stage clinical trial of a coronavirus vaccine. Half of the people received the vaccine, while the other half received a saltwater placebo. The companies then waited for people to get sick to determine if the vaccine offered any protection.
So far, 94 participants out of nearly 44,000 have fallen ill with Covid-19. An independent board of experts looked at how many of those people received the vaccine and how many received the placebo. That initial analysis suggests that the vaccine is more than 90 percent effective.
As is customary in clinical trials, the data was “blinded,” meaning that no one except the independent board – not volunteers, doctors, or senior company executives – knows how many of the 94 people sickened by the virus received the vaccine or the placebo. However, given the calculation that the vaccine is more than 90 percent effective, we can safely assume that very few people who were vaccinated contracted Covid-19.
Is. The Food and Drug Administration had set a 50 percent efficiency bar for vaccine manufacturers who wanted to submit their candidates for emergency clearance. If the preliminary results from Pfizer and BioNTech confirm, and accurately reflect how the vaccine will work in the real world, then it is much more protective than that.
To get an idea of how good these results are, it is worth considering the licensed vaccinations that people receive regularly. At the low end, flu vaccines are 40 to 60 percent effective at best, because the flu virus continues to evolve into new forms year after year. In contrast, two doses of the measles vaccine are 97 percent effective.
So far, Pfizer and BioNTech have not reported serious safety issues with their vaccine. Before running the current large-scale study, the companies conducted smaller clinical trials starting in May that were specifically designed to detect warning signs about the safety of the vaccine. They tested four versions of their vaccine and selected the one that produced the fewest cases of mild and moderate side effects, such as fever and fatigue.
If your vaccine receives an emergency clearance from the FDA and is distributed to millions of people, the Centers for Disease Control and FDA will monitor them to make sure there is no evidence of even more rare safety issues.
Participants in the trial will also be monitored for two years.
Pfizer’s chief executive has said he could have 30 to 40 million doses of the vaccine before the end of the year, enough for 15 to 20 million people to receive an initial injection and a booster three weeks later.
Exactly who will qualify for the initial doses has not been decided, but groups that are at higher risk of infection or most vulnerable to the virus are likely to take priority. That could include healthcare workers as well as older adults and those with risk factors like obesity or diabetes.
Pfizer and BioNTech say they could increase up to 1.3 billion doses a year. That is still far from enough to meet the global need for vaccines. If other vaccines are also effective, companies will also be able to make them and help meet demand.
Pfizer has said that it will likely apply for an emergency authorization in the third week of November, after collecting the two months of safety data that the FDA has asked manufacturers to submit. The agency will then consult with an external advisory committee of experts, and it can take weeks to sift through detailed data on safety, efficacy, and companies’ ability to make millions of doses safely.
The vaccine could be licensed for certain high-risk populations before the end of the year, but that would only happen if everything goes according to plan and there are no unforeseen delays.
The trial will continue until reaching 164 cases of Covid-19. At that time, the study will be complete and the results will be analyzed.
While preliminary results provide compelling evidence that the vaccine is effective, they do not tell us for sure how effective it is. Clinical trials are simply not set up to do that. They can only allow scientists to make an estimate based on statistics, an estimate known as efficacy. The effectiveness of a vaccine can only be firmly determined once it has been received by millions of people. But experts say preliminary data indicates that the effectiveness should be very high.
The new results also don’t tell us whether older people will receive strong protection from the vaccine. The Pfizer and BioNTech clinical trial includes people over the age of 65, so it will eventually provide this crucial information. Early clinical studies have suggested that older people produce a weaker immune response to coronavirus vaccines. But with such strong preliminary evidence, they may still get strong protection from a vaccine.
Another open question is whether children will receive protection from the vaccine. The test conducted by Pfizer and BioNTech was initially open to people 18 and older, but in September they began to include 16-year-olds. centuries.
On Monday, Vice President Mike Pence said in Twitter that the news came “Thank you to the public-private partnership forged” by Mr. Trump.
In July, Pfizer secured a $ 1.95 billion settlement with the government’s Operation Warp Speed, the multi-agency effort to bring a vaccine to market and deliver 100 million doses of the vaccine. The agreement is an advance purchase agreement, which means that the company will not be paid until the vaccines are delivered. Pfizer did not accept federal funding to help develop or manufacture the vaccine, unlike pioneers Moderna and AstraZeneca.
Pfizer has distanced itself from Mr. Trump and Operation Warp Speed. In an interview Sunday, Kathrin Jansen, Senior Vice President and Head of Vaccine Research and Development at Pfizer, said, “We are never part of Warp Speed,” adding, “We have never received money from the US government, nor from no one “.
On Monday, a Pfizer spokeswoman clarified that the company is part of Operation Warp Speed as a supplier of a possible coronavirus vaccine.
While it is true that Pfizer and BioNTech had been working on a vaccine all year before the companies reached their agreement with the US government. In July, a $ 1.95 billion agreement is nonetheless. a significant incentive to keep going. In fact, international health organizations have long used these market guarantees to encourage for-profit manufacturers to supply vaccines to the developing world.
Currently, there are 10 other vaccines in late-stage trials around the world. The fact that Pfizer and BioNTech have obtained encouraging results makes experts optimistic about the entire field.
“It gives us more hope that other vaccines will also be effective,” said Akiko Iwasaki of Yale University.
Pfizer and BioNTech are testing a vaccine that uses a genetic molecule called RNA to make our own cells produce a viral protein. Our immune system encounters the protein and produces antibodies and immune cells that can quickly recognize the protein and launch a quick attack. Moderna is in late-stage trials with a proprietary RNA vaccine, and the first clinical trials of other RNA vaccines are ongoing in China, England, India, Singapore, South Korea and Thailand.
But the news from Pfizer and BioNTech could also be encouraging for other vaccine developers. The Pfizer and BioNTech vaccine causes our bodies to make a viral protein called spike. Several other vaccines deliver the spike protein to the body, or just a fragment of it, that causes the immune system to recognize it. Other vaccines are based on other viruses, which harmlessly pass a gene for the spike protein into cells. If the spike protein generates strong protection against coronavirus, then all of these vaccines could offer encouraging results in the coming months as well.
The widespread success of coronavirus vaccines would be a boon for global health, because Pfizer and BioNTech alone cannot meet the full demand.
Please do not do it. The coronavirus is sweeping across the country and public health experts have said that Americans should be prepared for a very harsh winter.
Even if a vaccine is licensed in a few months, it will initially only be available to a portion of the American public. Most health officials believe that an effective vaccine won’t be available to those who want it until well into next year. Even then, there is still no data on whether a vaccine will stop the asymptomatic spread of the virus, or to what extent it will prevent people from developing severe Covid-19.
Most experts say that even when a vaccine is widely available, additional measures such as masks will be necessary until the threat to public health has abated.
“This will not replace hygienic measures, it will be a supplement to hygienic measures,” said Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel. “You owe it to others to make sure you wear a mask.”
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