There is some good news for Americans with regards to the covid-19 vaccine developed by Pfizer and its partner by BioNtech. They had recently announced that the vaccine was 95% effective against the coronavirus. They have now requested the FDA for emergency use authorisation. If the vaccine is authorised by the FDA, frontline workers can expect to get the vaccine before the end of this year.
Even though many people are enthusiastic about the development of vaccines in such a short interval of time, some people are sceptical about the safety concerns. In normal conditions, the process for getting approval for any vaccine takes many years of trials. On the other hand, the vaccine for the covid-19 is being approved in just a matter of a few weeks even as the clinical trials are still in progress.
Dr Fauci has now clarified all the doubts in this regard and said that Americans need not worry about safety concerns once the vaccine is approved by the FDA. He said that an independent data monitoring committee would review the clinical trial data before recommending it to the FDA for authorisation. The committee consists of career scientists, and they have relevant experience in clinical trials.
As part of the process, the committee members will monitor the safety and effectiveness of the vaccine throughout the trials and even consider making suitable changes depending on new data that may come out from other studies. The vaccine developed by Pfizer has not shown any serious safety concerns so far. Apart from the data monitoring committee, another group of outside experts who advise the FDA on providing approval to drugs will also look into the data. These groups are scheduled to meet on 10th December to evaluate the candidate vaccine for its safety and effectiveness.
The evidence will be made public in the next few weeks after the FDA will meet its advisory board and discuss the safety and effectiveness of the vaccine. The FDA will also release its internal analysis before authorising candidate vaccines.
Dr Fauci said that even if the candidate vaccine is approved by the FDA and distributed for public use, it is still considered investigational. The study on trial participants will continue for a long time, and the data will be continuously monitored by the FDA and other data monitoring groups.
He added that the American public should feel confident about the vaccine once it is approved by the FDA, and he expects that complete normalcy can be stored by the end of 2021. It is also important to note at this stage that the vaccine will not be effective in preventing the coronavirus completely if enough people do not take the vaccine. If close to half of the population do not get vaccinated, the effectiveness of the vaccine across the community will be reduced to a large extent.
According to surveys conducted by several Healthcare groups, nearly one-third of the population expressed their doubts about the safety and need for the candidate vaccine. Most people are still not convinced about the seriousness of the pandemic. They are not taking enough safety precautions to control the virus. It can be challenging to convince such people to get vaccinated shortly.
Usage of masks in public places has become a hot topic in the last few months. Apart from that, not many people are convinced about maintaining social distancing in public places. All these things have resulted in a huge spike in the number of coronavirus cases across the country.
Given the situation, it can be tough to convince a major portion of the American population to use the vaccine. However, there is some hope with regards to fighting the coronavirus as the vaccine will at least protect the Frontline workers immediately, and they can work with confidence in the long run.
According to health experts, the candidate vaccine will be available for frontline workers as early as December. There is a critical need to protect them in this situation, as most of them lack the protective gear required to fight the covid-19 situation. Once they get vaccinated, they will be safe, and they can work with confidence. The vaccine will be distributed in a phased manner, and the general public will be eligible to get the vaccine in the next couple of months.
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