Testing times: More work needed on Astra/Oxford vaccine trials
By Kate Kelland LONDON (Reuters) - AstraZeneca and Oxford University have more work to do to confirm whether their COVID-19 vaccine can be 90% effective, peer-reviewed data published in The Lancet showed on Tuesday, potentially slowing its eventual rollout in the fight against the pandemic. Once seen as the frontrunner in the development of a vaccine against the coronavirus crisis, the British team was overtaken by U.S
By Kate Kelland
LONDON (Reuters) - AstraZeneca and Oxford University have more work to do to confirm whether their COVID-19 vaccine can be 90% effective, peer-reviewed data published in The Lancet showed on Tuesday, potentially slowing its eventual rollout in the fight against the pandemic.
Once seen as the frontrunner in the development of a vaccine against the coronavirus crisis, the British team was overtaken by U.S. drugmaker Pfizer, whose shots - with a success rate of around 95% - were administered to UK pensioners on Tuesday in a world-first hailed as V-Day.
Detailed results from the AstraZeneca/Oxford trials have been eagerly awaited after some scientists criticised a lack of information in their initial announcement last month.
However, the Lancet study gave few extra clues about why efficacy was 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.
"(This) will require further research as more data becomes available from the trial," the study said.
Less than 6% of UK trial participants were given the lower dose regimen and none of them was aged over 55, meaning more research will be needed to investigate the vaccine's efficacy in older people who are particularly susceptible to COVID-19.
Pooling the results, overall efficacy was 70.4%, the data on Tuesday showed. That is above the 50% minimum set by the U.S. Food and Drug Administration.
COVID-19 vaccines from Pfizer and its German partner BioNTech and from Moderna have reported efficacy levels of more than 90% in late stage trials.
But the AstraZeneca/Oxford vaccine is seen as particularly important to tackling the pandemic in the developing world, as it would be cheaper and easier to distribute.
"The basic message: that the overall efficacy across the trials that are reported here is about 70% but with a clear description of its uncertainty," said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.
"The statistical uncertainty is that the efficacy could be as low as 55% or as high as 80%. The Pfizer/BioNTech and Moderna vaccines both have efficacies above 90% and are clearly more efficacious under trial conditions."
Asked whether the half, then full dose regimen had been a mistake, Andrew Pollard, director of the Oxford Vaccine Group and chief investigator into the trials, told a news conference it had been "unplanned."
Mene Pangalos, head of AstraZeneca's non-oncology research and development, said requests for regulatory approval around the globe could still be submitted this year.
"We hope that once the regulatory authorities review the data, we can get approval any time from the completion of the submission, which could be any time from the end of this year to early next year," he said.
However, Pollard conceded the different results from the two dosage regimens complicated matters.
"The regulators will decide exactly what their label should say," he said, when asked whether regulators might approve the two full shots regiment first, and then potentially the half, then full, shot regiment when more data is in.
Pangalos also said he assumed U.S. regulators would want to see results from an ongoing trial in the United States before giving their approval.
He left it open whether a costly new trial was needed, as the company previously said was likely, because more infections in the ongoing trials may provide the needed clarity.
"We haven’t yet decided on what a next study would be, if we do a next study ... we will decide in due course."
Pfizer on Tuesday cleared the next hurdle in the race to get its vaccine approved for U.S. emergency use after the Food and Drug Administration (FDA) released documents that raised no new issues about its safety or efficacy.
The Oxford researchers, in turn, said their vaccine was found to be safe, with three out of the roughly 23,700 participants experiencing serious conditions that were possibly related to either the COVID-19 vaccine or a standard meningitis vaccine given to a control group.
A case of a serious neurological illness, transverse myelitis, was reported 14 days after a COVID-19 vaccine booster shot, which was "possibly related to vaccination," they said.
This case had led to a seven-week trial suspension in the United States and to brief halts in trials in other countries.
A case of fever above 40°C occurred in South Africa, but it was not disclosed whether this participant received the vaccine because the person recovered quickly and is continuing the trial without knowledge of the shot received, as is the norm.
(Reporting by Kate Kelland in London and Ludwig Burger in Frankfurt, editing by Josephine Mason and Mark Potter)
This story has not been edited by Firstpost staff and is generated by auto-feed.
By Robin Emmott and John Irish | BRUSSELS/PARIS BRUSSELS/PARIS France and Germany will agree to a U.S. plan for NATO to take a bigger role in the fight against Islamic militants at a meeting with President Donald Trump on Thursday, but insist the move is purely symbolic, four senior European diplomats said.The decision to allow the North Atlantic Treaty Organization to join the coalition against Islamic State in Syria and Iraq follows weeks of pressure on the two allies, who are wary of NATO confronting Russia in Syria and of alienating Arab countries who see NATO as pushing a pro-Western agenda."NATO as an institution will join the coalition," said one senior diplomat involved in the discussions. "The question is whether this just a symbolic gesture to the United States
BEIJING Chinese President Xi Jinping on Wednesday called for greater efforts to make the country's navy a world class one, strong in operations on, below and above the surface, as it steps up its ability to project power far from its shores.China's navy has taken an increasingly prominent role in recent months, with a rising star admiral taking command, its first aircraft carrier sailing around self-ruled Taiwan and a new aircraft carrier launched last month.With President Donald Trump promising a US shipbuilding spree and unnerving Beijing with his unpredictable approach on hot button issues including Taiwan and the South and East China Seas, China is pushing to narrow the gap with the U.S. Navy.Inspecting navy headquarters, Xi said the navy should "aim for the top ranks in the world", the Defence Ministry said in a statement about his visit."Building a strong and modern navy is an important mark of a top ranking global military," the ministry paraphrased Xi as saying.