According to a Reuters report, Pfizer Inc said on Tuesday that their vaccine trial participants were showing mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.
Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.
Scrutinizing Safety
The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech.
Pfizer said it was continuously scrutinizing the safety and tolerability of the vaccine in its study.
An independent data monitoring committee could recommend pausing the study at any time, but has not done so till date, the company said.
Trial Blueprint Released
US biotech firm Moderna, one of nine companies in the late stages of clinical trials for a Covid-19 vaccine, became the first to publish the complete blueprints of its study following calls for greater transparency.
Pfizer, the other American company currently carrying out Phase 3 trials in the US, followed suit a short time later and there is now added pressure for the remainder to do the same.
Phase 3 is the final stage before approval, in which a vaccine and a placebo are tested on thousands of participants to verify the medicine is safe and effective.
Moderna also said that 28% of its participants were from racial minority groups.
Having sufficient participants among black and Hispanic people in particular is crucial in obtaining statistically representative results for these communities that have been disproportionately hit by the pandemic.
The decision by Moderna, which has received $2.5 billion in US government money, left a spotlight on Pfizer, whose CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump’s wishes.
A spokeswoman told AFP Pfizer has traditionally not shared the full in-depth study protocol, but “the Covid-19 pandemic is a unique circumstance and the need for transparency is clear.”
“As a result, the company is making the full protocol for its self-funded Covid-19 vaccine pivotal study available to reinforce Pfizer’s longstanding commitment to scientific and regulatory rigor that benefits patients.”
AstraZeneca’s Trials Resume
The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.
AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.
Did you subscribe to our daily newsletter?
It’s Free! Click here to Subscribe!
Source: Reuters
