A recent company study shows that even after 6 months of receiving a second dosage of the Pfizer-BioNTech vaccine as a result of a 46,000-person medical experiment, participants remained immunized for over 90%.
A recent study that was conducted by the drug companies shows that the vaccine remains highly effective for a period of 6 months and not only that, but it also protects the individuals against any serious disease.
Pfizer Covid-19 Vaccine Keeps On Being Over 90% Effective For 6 Months
Among the 927 volunteers who fell sick with Corona virus over seven days after their second shot, only 77 had gotten the active vaccine, while the rest 850 volunteers received a placebo.
Out of the 12,000 participants who have passed 6 months post their second shot, no individual exhibited any severe health concern. However, the recent findings suggested that many individuals developed typical temporary aftereffects such as fatigue and sore arms.
The new data, as procured in the research, is possibly adequate for the vaccine to suffice the requirements established by the Food and Drug Administration for complete authorization.
The three corona virus vaccines that have been approved by the FDA so far, including Moderna, Pfizer-BioNTech and Johnson and Johnson, are being distributed under the Emergency Use Authorizations and not the full FDA Biologics Licenses, owing to the fact that the vaccines did not present enough data that would suggest long-term safety and effectiveness.
The federal agency permitted the pharmaceutical companies to cite data of only two months with the aim that they could provide the Covid-19 vaccines to the public faster in a global emergency. The FDA had previously said that they would review the vaccines and issue a full license once the vaccines exhibit satisfactory track record of six months. The same criteria applies for vaccines of other contagious diseases.
The U.S. based pharmaceutical company Pfizer along with the German biotechnology company namely BioNTech that jointly formulated the vaccine, have provided immunization shots to an estimate of 77 million Americans. The companies intend on submitting their application to the agency for a full license, some time this month.
In a prepared announcement, the CEO of Pfizer, Albert Bourla, sounded confident about submitting an application and subsequently, receiving approval from the U.S. FDA.
Luciana Borio, who formerly served as a principle scientist at FDA, said that it is “pretty safe” to think that the drug companies will receive full approval from the agency, given their performance. She sounded hopeful and said that the approval would mean one less cause for the skeptics to dismiss vaccination.
However, despite such convincing arguments, it is unclear whether the approval would mean much difference for the general public. The primary benefit of the licensure is to seek assurance for the company that its authorization will not come to an end. The Biologics Application, once approved, offers 12 years of exclusivity for a company’s product.
On the other hand, Emergency Use Authorizations are short-term and can be terminated by the FDA any time they deem necessary for any particular reason. Technically, the length of service of an EUA would also run out once the “emergency” ends.
This approval will, thus, merely allow the companies to establish their product in the market for an indefinite period as opposed to the EUA which would have perished along with the end of the pandemic.
The FDA agency is also likely to inspect an application for approval, within the next few days, for Covishield, a vaccine that was jointly formulated by AstraZeneca and Oxford University.