The American multinational pharmaceutical corporation Pfizer said on Tuesday, September 15 that participants of its Coronavirus vaccine trial were showing mild-to-moderate side effects. The company said they noticed the side effects when given Pfizer's COVID-19 vaccine or a placebo during an ongoing late-stage study.
Pfizer said in a presentation to investors that the side effects included fatigue, headache, chills, and muscle pain, while some volunteers participated in the trial also developed fever - including a few who with high fever. The data is blinded which means that the company does not know which patients received the vaccine or a placebo.
More than 12,000 participants had received a second dose of the vaccine as of now. Pfizer has enrolled over 29,000 people in its 44,000-volunteer trial to test the experimental vaccine which the company is developing along with the German partner, BioNTech.
The company said it has been continuously scrutinizing the safety and tolerability of the vaccine in its study. Pfizer's head of vaccine research and development, Kathrin Jansen said that the independent data monitoring committee has access to the unblinded data, "so they would notify us if they have any safety concerns and have not done so to date."
The recent findings during the Pfizer vaccine trial were reported after the Oxford University and AstraZeneca's COVID-19 vaccine trials being put on hold worldwide on September 6. While in the US the vaccine trial remains on hold, the other tails of the vaccine resumed in the UK after regulators completed their review of serious side effects on trial participants. The AstraZeneca vaccine trial in the US will remain on hold until the Food and Drug Administration (FDA) gives its approval for trials again.
'Only One Drugmaker Has a Chance'
An effective Coronavirus vaccine development before the November election in the US is a real long shot, but as per Microsoft co-founder Bill Gates, only one company has a chance at seeking approval by next month.
He told CNBC that while many other pharma companies are in the race, only Pfizer could possibly deliver the vaccine in a matter of weeks. He said, while none of the COVID-19 vaccines are likely to seek approval in the US before the end of October, the only vaccine that "if everything went perfectly, might seek the emergency use license by the end of October, would be Pfizer."