A COVID-19 vaccine candidate has been 90% effective at protecting people from the coronavirus, Pfizer and BioNTech stated last Monday. The FDA previously said that it would require any vaccine to be at least 50% effective for it to be approved.
“If that headline really number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference,” stated the dean of the School of Public Health at Brown University, Ashish Jha.
The claim is based on early data from a huge trial that has enrolled 43,538 people so far. Pfizer and BioNTech have only publicly released some of the data in their announcement recently, and independent scientists haven’t reviewed it. The companies still gather information from the trial and warn in the announcement that the “final vaccine efficacy percentage can be varied.”
The vaccine by Pfizer and BioNtech is built with unproven gene-based technology. The strategy works by introducing a little snippet of the coronavirus’s genetic material to the body. After that, cells use instructions encoded by the genetic snippet to create that piece of the virus, and then the immune system will learn to fight against it. Moderna’s vaccine also uses the same strategy.
Gene-based vaccines are to be stored at ultracold temperatures; thus, it will be more difficult to transport. The Pfizer/BioNTech vaccine has also taken two doses, which needs to be given three weeks apart. The companies claim that “protection is achieved” seven days after the patient gets their second dose. But it is not clear how much protection will be offered by just one of the two doses.
Before the vaccine can be issued, it needs to be authorized by regulatory bodies, along with the FDA, which will look at how safe and effective the vaccine is. There is no serious safety concern for this vaccine that has been reported yet. But the recent information doesn’t include the information on how many people developed more severe forms of the disease and how many have milder cases – this will be taken into consideration by the FDA during their evaluation.
The companies state that they should have sufficient safety data from their studies to file for Emergency Use Authorization from the FDA by the 3rd week of November.
Pfizer and BioNTech had an agreement with the US Department of Health and Human Services to afford up to 600M doses of their vaccine for $1.95B. The companies said they could manufacture 50M doses of the vaccine this year and 1.3B doses in 2021.
Even if the FDA has authorized the vaccine, it won’t be available to everyone as soon as possible. It will likely be distributed to the healthcare workers first and then to other groups with a high risk of severe cases of COVID-19. A bigger challenge still ahead is the logistics of getting shots in the arms of people who need it the most.
Other pharmaceutical companies also have vaccine candidates in phase 3 of clinical trials; the initial results from some of the trials can be released soon. More than one can be proven effective, and the FDA can authorize more than one. Last month, the Coalition for Epidemic Preparedness Innovations said that it would run studies comparing the options in the hopes of recognizing which can work best.
Developing a vaccine is an important step in fighting the spread of the virus; however, it cannot bring the pandemic to an instant end. It will take months to get people vaccinated. In the meantime, the virus continues to spread around the Earth, and the US sees record-breaking spikes, having more than 100,000 cases reported every day. To slow down the rampant spread of the disease, people are still advised to wear masks, wash their hands, and keep their distance.
“It is not going to eliminate the need to be prudent and careful with our public health measures,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, started in October.