AstraZeneca has been accused of having ‘included outdated information’ from the US trial of its COVID-19 vaccination, which may have ‘provided an incomplete view of the efficacy data’.
The National Institute of Allergy and Infectious Diseases raised concerns on Monday night, hours after the pharmaceutical firm said it will file for Food and Drug Administration (FDA) authorization of its COVID-19 vaccine in the first half of April.
In a statement, the NIAID said that its Data and Safety Monitoring Board (DSMB) was seeking further information.
‘We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,’ NIAID said.
The NIAID did not specify what outdated information AstraZeneca relied on from its trial.
Hours earlier, the UK-Swedish company, with its headquarters in the British city of Cambridge, announced that it planned to file in the first half of April for the emergency use authorization with the FDA.
AstraZeneca, whose North American headquarters (pictured) are in Wilmington, Delaware, was asked Monday for more data
It would then be in the hands of the FDA as to how fast it can decide whether it will be approved.
‘Assuming that the approval will take place in a fast way, we hope to deliver 30 million doses instantly after the EUA for Americans to get vaccinated,’ said Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business unit, speaking on CNBC’s Squawk Box on Monday.
AstraZeneca’s coronavirus vaccine was described as being 100 per cent effective at keeping people out of hospital and stopping them dying of the disease.
An extra trial of the vaccine in America was initially believed to have found it was more effective than it was in the UK research – preventing 79 percent of all symptomatic infections – and nobody got seriously ill.
That data is now being called into question, as is the claim it works just as well in over-65s as it does in younger people.
The study was the largest one so far conducted on older people, including more than 6,000 of them.
The trial — which involved 32,000 people in total — also said to have confirmed the vaccine doesn’t increase the risk of blood clots, which is a confidence boost after safety concerns in Europe rattled public faith in the jab last week.
Two doses were given four weeks apart in the study and the effectiveness of a single dose was not reported. Full results from the trial are expected to be published later in the year.
American authorities had insisted the vaccine was trialed in the US before they agreed to approve it and the extra research adds to proof the jab works.
AstraZeneca said it will apply for US approval in the coming weeks.
It is unclear how much of a delay the NIH statement will cause.
AstraZeneca had hoped that their vaccine would be granted FDA approval in the coming weeks, but that may now be delayed
The authorization had been expected next month.
Oxford’s Professor Andrew Pollard, who runs the vaccine trials, said the results were ‘remarkable’, and its inventor Professor Sarah Gilbert said she was ‘very pleased’.
Dean of Brown University’s School of Public Health, Dr Ashish Jha, called the results ‘fabulous news’ in a tweet and told the Today Show that the AstraZeneca shot is the ‘best ticket towards vaccinating the world.’
The jab-makers were in need of good press after the past fortnight saw more than a dozen European countries shun the jab amid fears it could cause blood clots on the brain – on which most have now backed down, although Sweden, Denmark and Norway are still hesitating and refusing to use it.
The Trump administration made a deal with AstraZeneca for 300 million doses of AstraZeneca’s vaccine last year, and the federal government is currently sitting on nearly 30 million which can’t be used until the shot is authorized by the FDA.
Nearly four million of those doses were sent to Mexico and Canada which have both authorized the shot last week, since they are useless to Americans for the time being.
The US is vaccinating an average of 2.5 million Americans a day, has enough vaccine ready to go to cover 19 percent of people in the US, and has already given one or more dose to nearly a quarter of its population.
But the addition of the AstraZeneca shot would dramatically accelerate the pace of vaccinations and bring the US closer to having enough doses in its stockpile for its entire adult population.
Meanwhile, Boris Johnson is preparing to call EU leaders demanding they shun ‘vaccine nationalism’ amid fears they will push ahead with an export ban that could delay the UK’s rollout by months.
Britain will also have to cope with five million fewer doses of the jab than expected in April because an expected shipment from India has been cancelled.
This is expected to mean the vaccine drive, which gave out a record 844,285 jabs on Sunday, will have to stick mainly to second doses instead of new patients.
The US trial initially found that the Oxford/AstraZeneca vaccine was more effective than expected after results from the UK trial – while both found it to be 100 percent effective at preventing hospital admission or death, the US one saw it prevent 79 percent of all infections compared to 76 percent in the UK
The Oxford scientists behind the vaccine, Professor Sarah Gilbert and Professor Andrew Pollard, both hailed the success of the vaccine in yet another trial, saying it proves the jab is safe and effective
The Oxford/AstraZeneca coronavirus vaccine is already widely used but the US Government had insisted on a trial done on Americans before it agreed to approve the jab (Pictured: A man preparing a dose of the jab in Bridport, England)
Some 32,449 people across all age groups took part in the phase three trial in the US, Chile and Peru, with a total of 141 cases of symptomatic COVID-19 reported.
Around two thirds of all the participants had the real vaccine – 21,583 – and the rest had a fake jab so the effects could be compared. Full results of the trial have not yet been published.
The initial results showed that among people aged 65 and over, there was 80 percent protection against developing symptomatic COVID-19, Oxford said.
This comes after officials in Europe, who had smeared the vaccine on yet another occasion, claimed that the vaccine didn’t work on people over 55 and tried to prevent it being used on elderly people.
Overall the study, which NIH said was incomplete, found that the effectiveness of the jab against symptomatic COVID was even higher than it had been in the original trials that took place in the UK, South Africa and Brazil.
EUROPE’S UNPROVEN BLOOD CLOT CLAIMS SHAKE PUBLIC FAITH IN OXFORD’S JAB
Confidence in Oxford/AstraZeneca’s Covid-19 vaccine has plunged across Europe, polls show.
European leaders paused the rollout of the jab last week over fears it caused blood clots.
The European Medicines Agency later said the vaccine was not associated with a higher clotting risk.
Nevertheless, more people in France (61 percent), Germany (55 percent) and Italy (43 percent) now believe the jab is unsafe, according to YouGov.
In France, this was a jump of 18 points since February, while in Italy it was a mammoth 27-point rise.
Faith in the vaccine in the UK was dented less but still fell. Nine percent of people said the jab was unsafe, a jump of four points.
But more than three quarters of Britons still say both the AstraZeneca and Pfizer jabs are safe.
YouGov lead data journalist Matt Smith said the European leaders’ concerns over the vaccine undoubtedly damaged its reputation.
He said: ‘Not only have we seen considerable rises in those who consider it unsafe in the last two weeks in Europe, the AstraZeneca vaccine continues to be seen as substantially less safe than its Pfizer and Moderna counterparts.
‘With a third wave of infections potentially emerging now across the Channel, officials everywhere will be worried if ongoing rows about AstraZeneca’s vaccine ends up damaging the rollout.’
‘These results are great news as they show the remarkable efficacy of the vaccine in a new population and are consistent with the results from Oxford-led trials,’ said Professor Pollard.
‘We can expect strong impact against COVID-19 across all ages and for people of all different backgrounds from widespread use of the vaccine.’
AstraZeneca has not yet published the full results of the trial, but its press release does not address whether or not the US trial screened participants for variants.
The older ‘wild-type’ coronavirus is still dominant in the US, but the UK’s B117 variant is gaining ground, and the Centers for Disease Control and Prevention (CDC) lists four additional variants as ‘concerning.’
In prior trials, the AstraZeneca shot was equally effective against B117, and worked well in Brazil where the P1 variant is dominant.
But it performed poorly in South Africa, where the B1351 variant is dominant.
Nonetheless, US health authorities are eager to add a fourth vaccine to the American arsenal.
AstraZeneca’s shot has already been authorized in more than 50 countries around the world, and has helped the UK’s vaccination campaign to race ahead of the America’s.
AstraZeneca’s US trial got a late start compared to its other global tests, beginning on August 28.
Trials were also protracted after the death of a participant in Brazil last year.
American regulators dragged out the trial pause even after other countries resumed their tests. AstraZeneca’s trial wasn’t allowed to resume for more than six weeks.
After European leaders this month claimed people were developing brain blood clots and even dying after having the AstraZeneca vaccine, inspectors looked at the risk of blood clots and found it was not increased at all.
They looked at a specific condition that had scared officials in Germany, called cerebral venous sinus thrombosis, and found there wasn’t a single case recorded in the clinical trial.
The European Medicines Agency itself – which first launched an investigation and triggered panic across the continent – last week admitted there was no proof of a link to blood clots and backed down on its warning.
Health officials around the world, including Britain’s regulator the MHRA and the World Health Organization, have urged countries to keep using the vaccine to stamp out coronavirus.
Professor Sarah Gilbert, the Oxford scientist who invented the jab, said on BBC Radio 4 today: ‘I’m very pleased to see these results.
‘Another large trial in different countries to what we had before again reporting on the safety and high efficacy of this vaccine, so it’s really good news to see that.’
She added: ’20 percent of people in this trial were over the age of 65 and there was no drop in protection for those people. It was just as good in the over-65s as it was in the younger people and that’s very clear from this trial.’
On Europe’s concerns, Professor Gilbert said: ‘I’d say the balance remains hugely in favour of using this vaccine. Across Europe there are thousands of deaths a day occurring from COVID.
‘It’s really important that we get the chance to protect people as quickly as possible, this vaccine is available for use in Europe and it will save lives.’
The US trial saw two doses given four weeks apart, whereas previous trials have shown that spacing the doses by 12 weeks made the vaccine more effective.
AstraZeneca said leaving an interval longer than four weeks – as is happening in the UK – can increase efficacy and ‘accelerates the number of people who can receive their first dose’.
This is understood to be because it allows the body to cement the immunity from the first dose before the second – the booster dose – provokes a second, separate reaction and lets the already established protection strengthen itself.
As part of an agreement with Oxford, AstraZeneca is supplying the vaccine on a not-for-profit basis for the duration of the pandemic and in perpetuity for low and middle-income countries.
The news comes as polling for YouGov suggests confidence in the safety of the vaccine has dropped in the last two weeks in Spain, Germany, France and Italy.
Some 55 percent of Germans said the AstraZeneca vaccine is unsafe while 32 percent said it is safe.
AstraZeneca’s vaccine was already seen as unsafe in France but concerns have increased even further, with 61 percent now saying it is unsafe while 23 percent say it is safe, according to the survey of almost 9,000 people in seven countries.
More than a dozen European countries suspended use of the vaccine over concerns about blood clots, although most have now resumed its use.
The European Medicines Agency and the World Health Organization (WHO) have ruled that the AstraZeneca jab is safe and effective.