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.
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.Follow our LIVE Updates on the coronavirus pandemic here
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
Original Source: https://www.moneycontrol.com/news/business/pfizers-covid-19-vaccine-update-candidates-trial-report-finds-no-major-safety-issues-5845921.html