Pfizer Says Late-stage Coronavirus Vaccine Study Shows Moderate Side Effects

Henrietta Strickland
September 16, 2020

An independent data monitoring committee could recommend pausing the study at any time, but has not done so to date, the company said.

It is not known whether the condition was caused by the experimental vaccine.

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 next most commonly reported symptoms were headache, muscle pain, chills and joint pain, respectively. They said that they will be following the instructions provided by the DCGI.

Brazil: Clinical trials for the coronavirus vaccine being developed by AstraZeneca and Oxford University resumed in Brazil on Monday, September 14 after the country's health regulator received confirmation over the weekend that its British equivalent MHRA had approved the resumption of clinical tests, a company representative said.

Company CEO Albert Bourla has said it is "likely" the U.S. will get a coronavirus vaccine treatment to the public before the end of the year.

"I can not say what the FDA will do", Bourla said.

CEO Albert Bourla says it could be distributed to Americans by end of the year.

AstraZeneca's COVID-19 vaccine trials were placed on hold worldwide on September 6 after a serious side effect was reported in one volunteer in the United Kingdom.

The patient is believed to be suffering a rare spinal inflammatory disorder called transverse myelitis. AstraZeneca announced that the centres were recruiting up to 30,000 participants for the third phase trials in the United States.

According to WHO, there are 35 candidate vaccines around the world now undergoing clinical evaluation.

It trains the body to recognize the coronavirus, which will send out an immune response if a person becomes infected.

Volunteers are expected to receive a second shot of the adenovirus-based viral vector vaccine within 21 days of the first.

Volunteers given either the low or medium dose generated not just antibodies against the virus but specifically neutralizing antibodies, meaning they stop the virus from infecting human cells.

"It may well be that one group has the right vaccine but the wrong delivery method, and only trials such as this will be able to tell us that", said Robin Shattock, who is leading the development of Imperial's vaccine.

Other reports by Click Lancashire

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