Unexplained illness puts halt to Covid vaccine trial
CLINICAL trials of one of the most advanced experimental Covid-19 vaccines, which is being developed by pharmaceutical company AstraZeneca Plc and Oxford University, were “paused” on Tuesday after a volunteer developed an unexplained illness.
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 underway, with nine companies already in latestage 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 on Tuesday that “we voluntarily paused vaccination to allow the 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.
Harvard epidemiology expert Bill Hanage wrote on Twitter: “While this is 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.”
Stat News reported that the ill vaccine volunteer was likely participating in a Phase 2/3 trial based in the UK.
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.
Across Europe, concerns are growing about a resurgence of the virus, with France tightening restrictions, cases in Britain spiking and schools resuming around the region.
In China, however, the virus has been all but banished through lockdowns and travel restrictions earlier in the year that have officials touting the nation as a coronavirus success story.
China’s leaders staged a triumphant ceremony to celebrate beating the coronavirus on Tuesday, with President Xi Jinping stating that China had passed “an extraordinary and historic test” during an awards ceremony for medical professionals.
Meanwhile, Indonesian Minister of Research and Technology Bambang Brodjonegoro on Tuesday said up to 98 million low-income patients in the country whose healthcare premiums are fully funded by the State through the Health Care and Social Security Agency (BPJS Kesehatan) will get the Covid-19 vaccine for free.
“Between 97 and 98 million PBI participants of the BPJS Kesehatan will get the vaccine for free. Of course, the government and the health ministry will see how it is for the non-PBI participants” he said in a hearing with House of Representatives Commission VII overseeing research and technology.
Bambang, who also heads the National Research and Innovation Agency (BRIN) and is the person-in-charge of the national team to accelerate the development of a possible Covid-19 vaccine, said that the government was currently calculating the total cost of the vaccine.
The government has allocated 280 billion rupiah ($18.9 million) in 2021 for the development of the locally produced Merah Putih vaccine – named after the
“Red and White” colours of the Indonesian flag.
However, Presidential Decree No 18/2020 on the national team for the acceleration of Covid-19 vaccine development opens the possibility of other sources of funding for the programme beyond the State budget.
The potential vaccine is currently being developed by a national consortium under the Research and Technology Ministry, led by the Eijkman Institute for Molecular Biology.
Other institutions that are also conducting research and development are the Indonesian Institute of Sciences (LIPI), the University of Indonesia (UI), the Bandung Institute of Technology (ITB), Gadjah Mada University (UGM) and Airlangga University (Unair).
The vaccine is expected to cover at least 50 per cent of Indonesia’s vaccine needs.