After nearly ten months of research, development, and testing there’s a vaccine on the world’s doorstep.
Pfizer and BioNTech have developed and recently tested BNT162b2—a COVID-19 vaccine which has been found to be over 95 percent successful in preventing the virus through multiple trials. The company reports that it will likely submit its candidate to the Food and Drug Administration “within days” for emergency use.
Ugur Sahin, CEO of BioNTech, reaffirmed his confidence in the company’s results.
“The data indicates that our vaccine ... is able to induce a high rate of protection against COVID-19 only 29 days after the first dose,” Sahin said.
“In addition, the vaccine was observed to be well-tolerated in all age groups with mostly mild to moderate side effects, which may be due in part to the relatively low dose.”
If approved by the FDA, the vaccine would then be sent to approval by international reviews for global use.
Agencies like the UK-based Medicines and Healthcare Products Regulatory Agency (MHRA), the National Institute for Biological Standards and Control (NIBSC), and the Coalition for Epidemic Preparedness Innovations (CEPI) will have a cooperative evaluation of the drug as its prepared to be shipped out.
Because of its fast-tracked development, there are some questions among experts about how reliable the vaccine will be in the long run. Where many vaccines are developed and tested over a span of years, BNT162b2 has been developed in a short period of time.
Paul Offit, the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia has his doubts, according to CNBC.
“These vaccines are going to be approved and then rolled out with basically a few months’ worth of data,” Offit said. “You’re not going to do a two-year study to see whether it’s effective for two years with more than 200,000 people dying this year.”
Like others experts in virology, Offit’s concern is that the vaccine will only be reliable for a small window of time, eventually requiring two or more doses to maintain its effectiveness.
Although pending final approval, testing results from Pifzer indicate a safe use of the vaccine by test subjects.
Of the 43,000 trial subjects, only 2 percent reported a headache side-effect after having had the vaccine administered, while 3.7 percent reported a feeling of fatigue.
The drug has also been shown to be 94 percent effective in protecting subjects over the age of 65. The lack of widespread side effects and an effective protection for the COVID-19 vulnerable is an astonishing feat.
Akiko Iwasaki, a researcher at Yale University told the The New York Times that the protection of a higher age demographic is a particularly difficult thing to achieve in virus vaccine development.
“It’s pretty amazing,” Iwasaki said. “We know from the influenza vaccine that it’s very difficult to achieve protection in this age group with vaccines.”
It’s an achievement she called “really remarkable.”