Unexplained illness halts COVID-19 vaccine trial

Published September 9, 2020, 4:51 PM

by Agence-France-Presse

LONDON — Clinical trials of one of the most advanced experimental COVID-19 vaccines, which is being developed by pharmaceutical company AstraZeneca and Oxford University, were “paused” Tuesday after a volunteer developed an unexplained illness.

In this file photo taken on July 21, 2020 a general view is pictured of the offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire. (Photo by Paul ELLIS / AFP)

With billions of people around the world still suffering from the fallout of the pandemic and the global death toll nearing 900,000, a worldwide race for a vaccine is under way, with nine companies already in late-stage Phase 3 trials.

Worldwide infections to date now stand at more than 27 million, and more than 890,000 people have died from the disease.

Russia has already approved a vaccine, and research published in The Lancet medical journal last week said patients involved in early tests developed antibodies with “no serious adverse events.”

But scientists cautioned the trials were too small.

A spokesperson for the AstraZeneca vaccine said in a statement Tuesday that “we voluntarily paused vaccination to allow review of safety data by an independent committee.

“‘This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

The company said that in large trials, illnesses will sometimes happen by chance but must be reviewed independently. AstraZeneca didn’t offer further details, but medical news site Stat News, which first reported the volunteer’s illness, quoted a source saying it had involved a “serious adverse reaction” to the vaccine.

“While this is obviously not great news, remember that fully investigating adverse reactions is a part of large scale trials and essential to ensure trust in any vaccine. It will, however, mean that results will be delayed,” Harvard epidemiology expert Bill Hanage wrote on Twitter.

According Stat News, the ill vaccine volunteer was likely participating in a Phase 2/3 trial based in the United Kingdom.

China, meanwhile, put its homegrown vaccines on display for the first time at a Beijing trade fair this week, and authorities hope the jabs will be approved for use by the end of the year.

The vaccines are among the handful to have entered Phase 3 trials.

Vaccine for Philippines

In the Philippines, Philippine Council for Health Research and Development (PCHRD) Executive Director Dr. Jaime Montoya told House members on Wednesday that holding clinical trials for a potential COVID19 vaccine in the Philippines will guarantee the country of access to the vaccine once it is proven effective.

“It’s not ethical to conduct a clinical trial in a country if that vaccine won’t be made available there once it is proven effective,” Montoya said during the Committee on Appropriation’s scrutiny of the proposed ₱23.8-billion budget of the Department of Science and Technology (DOST) under the 2021 National Expenditure Program (NEP).

“So there’s a guarantee, once the vaccine is proven effective, it must be available in the country,” he said.

“The question here is, will we get the vaccine immediately? Because we know that all countries are rushing to get their supply of the vaccine during this time of COVID-19,” Montoya noted.

The answer to this question, Montoya said, would largely depend on the government’s negotiation with the foreign vaccine developer, “on how we will jump ahead in the queue.”

“But we will definitely gain access to that vaccine,” he added.

The Philippines’ potential role as trial country for potential COVID19 vaccines is viewed by some as a bargaining chip in terms of assuring supply for the local population, which is estimated at 110 million.

This is especially useful for the country, which unlike richer nations can’t make advance payments or pre-orders to vaccine developers. (With a report from Ellson A. Quismorio)

 
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