90% influential COVID-19 vaccine, early data from the trials shows
On Monday, Pfizer and BioNTech, a vaccine manufacturer company, said that their vaccine candidate was 90% efficacious when it comes to protecting people from the Coronavirus. Previously the Food and Drug Administration(FDA) said that any vaccine to be approved has to be at least 50% effective.
In an interaction with STAT News, Ashish Jha, the dean of the School of Public Health at Brown University, said, “If the headline is correct, then it is really big news. It will surely make a huge difference and it was far better than my expectations.”
This unbelievable claim is bottomed upon the statistics from the huge trial where 43,538 people are registered. However, this claim is not verified by any other independent scientists. Pfizer and BioNTech only released this claim in their report. But the Company is still recovering data from their trials. And the Company reports that the “Vaccine’s efficiency percentage may still change.”
Pfizer and BioNTech’s vaccine is developed using a gene-based technology, which is still unproven technology. So let’s know how this technology works. Initially, a tiny fragment of Coronavirus’s genetic substance is introduced to the body. This genetic fragment then instructs cells to build a piece of virus and the immune system that can fight against actual Coronavirus. Moderna’s vaccine candidate used the same strategy.
The most challenging problem with this vaccine is that it needs to be stored at ultracold temperatures. And this also makes it difficult to transport. One more problem with the Pfizer and BioNTech vaccine is that it needs two doses to be given to a candidate, with a gap of three weeks. And this makes it logistically complicated to distribute in comparison with the vaccines that need only one dose.
The Company proclaims that they are not sure how much the vaccine was effective with one dose rather than two doses. But the Company also claims that with two doses of the vaccine, the patient will surely achieve protection against Coronavirus.
Before the vaccine is available for use, it must be verified by many authorities, which includes the FDA that configures the safety and effectiveness of the vaccine. However, no major complication for the vaccine was reported till. But there is no such data shown in the Company’s report, which shows the number of people who developed serious disease forms and milder forms of the disease. We should tell you that the FDA uses these data to evaluate the safety and effectiveness of the vaccine.
Companies should have enough data from their studies to take authority for the emergency use of vaccines from the FDA. In an agreement with the US Department of Health and Human Services, Pfizer and BioNTech say that they will give 600 million doses for $1.95 billion. The Company also claims that they will manufacture 50 million doses of the vaccine by the end of this year and about 1.3 million doses by the end of 2021.
It is important to know that even if the vaccine would get verified by the FDA, it will be distributed to health sector workers and then distributed to other high-risk groups like severe cases of COVID-19 patients and workers necessary for mobility in the country. Hence everyone would not get the vaccine immediately. And it was quite challenging to distribute the vaccine to people who need it most.
Many pharmaceutical companies whose candidates are in phase three clinical trials and their initial study data will be available soon. And more than one vaccine could qualify for FDA authorization.
To fight this deadly virus, it is very necessary to develop an effective virus. But we cannot stop the spread of viruses only by developing the COVID-19 vaccine because vaccination will take months to complete. Until then, to slow down the spread of viruses. We should have to wear masks, regular disinfection of our hands, and keep physical distance from each other.