Pfizer expects “conclusive data” by October-end and promised to make public all its safety and efficacy data in case of emergency authorisation for vaccine
Pfizer’s internal COVID-19 vaccine trial report has found no major safety issues with the vaccine candidate, taking into account 12,000 individuals who received their second doses.
Pfizer’s chief scientific officer Mikael Dolsten told investors in a virtual meeting that there are “no safety signals reported so far,” Bloomberg reported.
The trail also reached its 30,000 subject mark and is now targeting total enrolment of 44,000, which will include teenagers and people fighting medical conditions such as HIV, Hepatitis B and Hepatitis C. This was also stated by Pfizer CEO Albert Bourla on September 14.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The trial compares effects of two doses of the vaccine candidate jointly developed by Pfizer and BioNTech, to two shots of placebo. Further, the subjects and internal doctors are unaware of who got the vaccine shot – so as to eliminate bias when reviewing effects, the report added.
A committee of outside experts – with knowledge of which individuals were given vaccine shots, is also reviewing safety data on a weekly basis and are “not notified of any safety concerns to date,” Kathrin Jansen, Pfizer’s head of vaccine research said during the meet.
Worrisome adverse events haven’t appeared so far, but fatigue has been the most common side effect noticed during the trials so far, as per the company presentation.
The company expects “conclusive data” by October-end and promised to make public all its safety and efficacy data in case of emergency authorisation for the vaccine.
Bourla told the media that the company releasing data is “very unusual” but called it a “must” due to ongoing discussions with the US government and regulators. He had on September 14 said the Americans could get the vaccine by 2020-end if approvals come in.
Pfizer and BioNTech are expected to approach the US Food and Drugs Administration (FDA) for emergency authorisation use, but Bourla said “timing remains unclear.”
On distribution, Pfizer said in case it receives emergency authorisation, the company “has sufficient freezers and thermal shippers to transport the doses, which usually require ultra-low temperatures for long-term storage.”
Pfizer is however also working on developing a version that would allow storage at higher temperatures for longer periods and exploring a new formulation for single dosage, the report added.Follow our full COVID-19 coverage here