The United States will share up to 60 million doses of its AstraZeneca vaccine with other countries as they become available, the White House has announced.
The doses will be able to be exported in the coming months after a federal safety review.
The US has a stockpile of the vaccine even though its regulators have not yet authorized it for public use.
Critics have accused the government of hoarding the vaccine, while other countries are in desperate need.
Last month President Joe Biden pledged to share about 4 million doses of the AstraZeneca vaccine with Mexico and Canada – both of which have approved the vaccine.
The crisis in India has also piled pressure on the Biden administration to share US health resources.
On April 26, the White House said it expected that about 10 million doses of the AstraZeneca vaccine could be released when the FDA finishes its review in the coming weeks.
It said that another 50 million doses were in various stages of production.
At a news briefing, White House spokeswoman Jen Psaki said FDA officials would carry out quality checks on doses before they were exported.
She added: “Our team will share more details about our planning and who will be receiving offers from here, but we’re in the planning process at this point in time.”
The US has already announced that it will provide raw materials for Indian vaccine manufacturers as the country battles a devastating surge in cases.
In a “warm and positive” phone call with Indian PM Narendra Modi on April 26, President Biden promised more emergency assistance “including oxygen-related supplies, vaccine materials and therapeutics”, a White House statement said.
Washington is also looking at supplying oxygen, Covid tests, personal protective equipment (PPE) and the antiviral drug remdesivir to India’s health service.
The FDA has so far authorized three vaccines against Covid- 19: Pfizer BioNTech, Moderna and Johnson & Johnson (Janssen). Experts say it looks likely that these will provide all the country’s needs and the AstraZeneca jab may not be needed.
According to the latest figures, more than 53% of adults in the US have so far received at least one dose of vaccine.
Denmark has decided to completely stop the Oxford-AstraZeneca Covid vaccine rollout amid concerns about rare cases of blood clots, the first European country to do so fully.
The move is expected to delay Denmark’s vaccination program by several weeks.
Drug watchdog the European Medicines Agency (EMA) last week announced a possible link with clots but said the risk of dying of Covid-19 was much greater.
Several European countries had previously briefly suspended the AstraZeneca vaccine.
Most have now resumed vaccinations with AstraZeneca, but often with limits to older age groups.
On April 13, the US, Canada and the EU paused the Johnson & Johnson vaccine for similar reasons over clotting.
South Africa has also paused its use, despite the Johnson & Johnson being its preferred vaccine because of its effectiveness against the South African variant.
For both AstraZeneca and Johnson & Johnson, the blood clot side effects are extremely rare.
The EU’s vaccine rollout has been criticized by the WHO for being too slow, and there are concerns this latest delay could throw it into further turmoil.
Both vaccines work by a similar method, known as adenoviral vectors.
Danish officials said that all 2.4 million doses of the AstraZeneca vaccine would be withdrawn until further notice.
The Danish Health Authority said studies had shown a higher than expected frequency of blood clots following doses, affecting about one in 40,000 people.
It comes after two cases of thrombosis in Denmark were linked to vaccinations, AFP reported. One of the cases, in a 60-year-old woman, was fatal.
Director General Soren Brostrom said it had been a “difficult decision” but Denmark had other vaccines available and the epidemic there was currently under control.
However, the authority said it could not rule out using it again at another time.
During the press conference the head of Denmark’s Medicines Agency, Tanja Erichsen, fainted and was taken to hospital as a precaution. The agency later tweeted that she had recovered.
Almost one million people in Denmark have been vaccinated, with approximately 150,000 of them receiving the AstraZeneca vaccine. The Pfizer/BioNTech and Moderna vaccines are also in use.
Adenoviruses are found in humans and other animals. Scientists use a modified version of one of these adenoviruses, known as a vector, to deliver important instructions to cells, according to the CDC.
They work by entering cells and using the cell’s machinery to produce a harmless piece of the virus that causes Covid-19, known as a spike protein. The cell then recognizes that the spike protein does not belong there and this triggers the immune system to fight back against what it thinks is an infection.
This process allows our bodies to learn how to protect us against Covid-19, according to the CDC.
Regulators are now investigating whether an unusual immune response to the adenovirus vaccines is causing the rare but severe incidences of blood clotting.
An official from the FDA told Reuters it was “plainly obvious” that the cases of blood clots linked to the Johnson & Johnson vaccine were “very similar” to those linked to the AstraZeneca vaccine.
The US paused rollout of the Johnson & Johnson vaccine after six women under 50 developed rare blood clots after getting the shot. In the UK 30 people had developed unusual blood clots and seven of them had died after getting the Oxford-AstraZeneca vaccine, out of a total of 18 million vaccinated.
Some European countries have limited the use of adenovirus vaccines to older people, who have been less affected by the rare blood clotting condition.
After the Danish announcement, France said it viewed the AstraZeneca vaccine as an “essential tool”.
France will also go ahead with plans to give the Johnson & Johnson vaccine to those aged over 55, the spokesman said. The country has already received 200,000 doses. Belgium will also give the doses it has received, while Greece and Italy will not.
Meanwhile the Czech Deputy PM Jan Hamacek said he had instructed the Czech ambassador in Denmark to try to buy the 2.4 million AstraZeneca vaccines doses that the Danes would no longer be using.
Jan Hamacek said he would also travel to Moscow to arrange deliveries of the Russian Sputnik V vaccine – another adenovirus vaccine – once its use is approved by the EMA.
Denmark was the first country to postpone use of the AstraZeneca vaccine in March. It was followed by numerous other European countries.
In a separate development, the European Commission said Pfizer-BioNTech would deliver an extra 50 million doses to the EU in the next few weeks.
Germany’s vaccine committee (Stiko) has advised giving the Oxford-AstraZeneca Covid-19 vaccine only to people aged 60 + because of a risk of rare blood clots.
The German drugs regulator found 31 cases of a type of rare blood clot among the nearly 2.7 million people who had received the vaccine in Germany.
Canada earlier suspended use of the AstraZeneca jab in people under 55.
AstraZeneca said international regulators had found the benefits of its vaccine outweighed risks significantly.
The company said it was continuing to analyze its database to understand “whether these very rare cases of blood clots associated with thrombocytopenia occur any more commonly than would be expected naturally in a population of millions of people”.
“We will continue to work with German authorities to address any questions they may have,” AstraZeneca added.
The EU and UK medicine regulators both backed the vaccine after previous cautionary suspensions in Europe this month.
The European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency stressed that the benefits of the AstraZeneca vaccine continued to outweigh the risk of side effects.
AstraZeneca’s vaccine is one of the most widely used coronavirus vaccines in the West, and is meant to be supplied on a not-for-profit basis to the developing world.
The EU’s rollout of its vaccination program has been dogged by delays because of delivery and production problems, and Germany is among several states now fearing a third wave of infections.
On March 30, Italy’s PM Mario Draghi and his wife, who are both 73, received their first doses of AstraZeneca in a display of confidence in the vaccine.
Ahead of the Stiko announcement, the German cities of Berlin and Munich, and the region of Brandenburg, halted use of the vaccine in people below the age of 60.
“After several consultations, Stiko, with the help of external experts, decided by a majority to recommend the AstraZeneca Covid-19 vaccine only for persons aged 60 years and older on the basis of available data on the occurrence of rare but very severe thromboembolic side effects,” the committee said, as quoted by Reuters.
“Regarding the question of administering the second vaccine dose to younger persons who have already received a first dose of the AstraZeneca Covid-19 vaccine, Stiko will issue a supplementary recommendation by the end of April.”
Germany was one of the European states which briefly suspended use of the AstraZeneca vaccine earlier this month pending an EMA review into the possible link to blood clots.
When the EMA declared the vaccine “safe and effective”, Germany and others resumed its use but investigations continued.
The German medicines regulator, the Paul Ehrlich Institute, has found 31 cases of cerebral sinus vein thrombosis (CSVT) among people who received AstraZeneca in Germany.
Almost all the cases are reportedly in younger and middle-aged women.
France already limits use of AstraZeneca to those aged over 55.
AstraZeneca has announced it downgraded the efficacy result of its coronavirus vaccine trial in the United States after health officials questioned the results.
The company adjusted the efficacy rate of its vaccine against Covid-19 symptoms from 79% to 76%, but said the trial results confirm it “is highly effective in adults”.
US health officials had been concerned the trial was using outdated data.
AstraZeneca said it now looked forward to getting US regulatory approval.
The US trials of the AstraZeneca jab had involved more than 32,000 volunteers, mostly in America, but also in Chile and Peru.
In the results announced on March 22, the company said the vaccine was found to be 79% effective at stopping symptomatic Covid-19 disease and was 100% effective at preventing people from falling seriously ill.
On March 23, the National Institute of Allergy and Infectious Diseases said it had been informed by data and safety officials monitoring the trial that information may have been used that provided an “incomplete view of the efficacy data”.
Dr. Anthony Fauci, the White House’s Chief Medical Advisor, then warned reporters the company would “likely come out with a modified statement”.
AstraZeneca’s revised results now put the vaccine’s overall efficacy at 76% instead of 79%. Among the over 65s, its efficacy rose from 80% to 85% and against severe disease it remains 100% effective.
On March 25, Mene Pangalos, an executive vice president at AstraZeneca, said: “We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”
The US had ordered 300 million doses of the Oxford-AstraZeneca vaccine when it emerged as a frontrunner in the global race to immunize people against Covid-19.
However, delays and controversies have seen three other vaccines beat it to a US rollout.
France and Poland have re-imposed partial lockdowns as both countries battle a sharp rise in Covid-19 infections in recent weeks.
In France, some 21 million people in 16 areas, including Paris, are affected as the country fears a third wave.
In Poland, non-essential shops, hotels, cultural and sporting facilities are now closed for three weeks.
Poland has the highest new daily rates of Covid-19 cases since November 2020.
Covid-19 cases are also rising exponentially in Germany, with Chancellor Angela Merkel warning it is likely that the country will now need to apply an “emergency brake” and re-impose lockdown measures.
The vaccine rollout across the EU has been hindered by delayed deliveries, as well as the suspension in several countries of the use of the Oxford-AstraZeneca Covid-19 vaccine, over fears of possible side effects.
In France, the partial lockdown took effect from midnight on March 19.
Trains leaving Paris for parts of the country where lockdown restrictions do not apply, such as Brittany and Lyon, were reportedly fully booked hours before the measures were due to come into effect.
Traffic jams were reported on several roads leaving the capital.
The new restrictions are not as strict as the previous lockdown, with people allowed to exercise outdoors.
Non-essential businesses are shut, but schools remain open, along with hairdressers if they follow a “particular sanitary protocol”.
France has reported more than 4.2 million infections since the start of the outbreak, with nearly 92,000 Covid-related deaths, according to the data compiled by Johns Hopkins University in the US.
In Poland, the three-week lockdown began on March 20.
Polish health officials earlier warned the nationwide restrictions were necessary because of a rampant British variant of Covid-19 in the country. The variant now makes up more than 60% of infections.
Poland has had more than two million confirmed infections, and nearly 49,000 deaths, according to Johns Hopkins University.
Germany said on March 19 it was now classifying neighboring Poland as high risk. This means that from March 21 anyone crossing the border from Poland must provide a negative coronavirus test.
Despite assurances from the European medicines regulator that the AstraZeneca vaccine is safe and effective, some countries remain reluctant to resume their campaigns using the jab.
Germany, Italy, France, Spain and the Netherlands are among the countries that have restarted their AstraZeneca vaccination campaigns.
Health authorities in France have recommended that the AstraZeneca vaccine be offered only to people aged 55 and over.
Finland’s health authority has announced a pause in its use of the vaccine that will last at least a week. That move, which follows two reports of blood clots in patients who had received the jab in the country, was said to be a precautionary measure.
Meanwhile, Sweden, Denmark and Norway said on March 19 that they needed more time to determine whether they should resume AstraZeneca inoculations.
On March 20, Denmark said that two members of hospital staff in Copenhagen had developed blood clots after receiving the AstraZeneca vaccine.
The European Medicines Agency (EMA) has reviewed the AstraZeneca vaccine over fears of a link to blood clots and found it was not associated with a higher risk of clots.
The Netherlands has become the latest country to halt use of the Oxford-AstraZeneca Covid vaccine over concerns about possible side effects.
The WHO and the European Medicines Agency (EMA) say there is no indication of a link between the vaccine and reports of blood clots.
Eight countries have so far fully suspended the AstraZeneca vaccinations.
The WHO told Reuters it was important that vaccination campaigns continued.
About 17 million people in the EU and the UK have received a dose of the vaccine, with fewer than 40 cases of blood clots reported as of last week, AstraZeneca said.
Experts say the number of blood clots reported after the vaccine were no more than those typically reported within the general population.
However, the Dutch government said its suspension, which will last until at least March 29, was a precaution.
Ireland, Denmark, Norway, Bulgaria and Iceland have paused inoculations with AstraZeneca vaccine, while the Democratic Republic of Congo and Indonesia have delayed the start of their AstraZeneca rollouts. Several European countries, including Italy and Austria, have suspended the use of certain batches of the drug as a precautionary measure.
Thailand announced that it would start using the vaccine on March 16, following a brief delay to the rollout over safety concerns.
The EMA – which is currently carrying out a review into incidents of blood clots – said the vaccine could continue to be administered.
In a statement, the Dutch government said it was acting out of precaution following reports from Denmark and Norway of possible serious side effects.
Dutch drug watchdog Pharmacovigilance Centre Lareb later said that 10 cases of possible adverse side effects had been reported in the Netherlands, according to Reuters.
“We can’t allow any doubts about the vaccine,” Health Minister Hugo de Jonge said.
“We have to make sure everything is right, so it is wise to pause for now.”
Speaking on an early morning talk show on March 15, Hugo de Jonge said he hoped the suspension would last “no longer than a couple of weeks”, adding: “We need vaccines to be able to put this nasty period behind us.”
The government’s decision will now cause delays in the Dutch vaccination program.
The authorities had pre-ordered 12 million doses of AstraZeneca, with nearly 300,000 shots scheduled in the next two weeks.
AstraZeneca said there was no evidence of an increased risk of clotting due to the vaccine.
It said that across the EU and UK there had been 15 events of deep-vein thrombosis (DVT) – a blood clot in a vein – and 22 events of pulmonary embolism – a blood clot that has entered the lungs – reported among those vaccinated.
AstraZeneca said these figures were “much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines”.
Denmark has temporarily suspended use of the Oxford-AstraZeneca Covid vaccine as a precaution, after reports of a small number of blood clots and one death.
According to the Danish health authority, it was too early to say whether there was a link to the AstraZeneca vaccine.
Austria earlier stopped using a batch of the drug, prompting the EU medicines agency (EMA) to say there was no indication the vaccine caused blood clots.
AstraZeneca says its safety has been studied extensively in clinical trials.
A spokesperson said: “Patient Safety is the highest priority for AstraZeneca.
“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes Covid-19 Vaccine AstraZeneca.”
Peer-reviewed data confirmed it had been “generally well tolerated”, the statement added.
Denmark’s decision came days after Austria suspended use of a particular batch of the drug because a woman died 10 days after taking it. Estonia, Latvia, Lithuania and Luxemburg have also stopped using the batch.
Danish authorities said they were pausing use of the vaccine for 14 days in what Health Minister Magnus Heunicke called a “precautionary measure”.
Although no link had been established, he said “we must respond in a timely and careful manner” until a conclusion was reached.
The decision to put the vaccine on hold in Denmark and Austria is a setback for a European vaccination campaign that has stuttered into life, partly due to delays in delivery of the AstraZeneca drug.
The Danish authority said it was not an easy decision as it was during the biggest and most important rollout in the country’s history.
The EMA said its safety committee was reviewing the Austrian case, but made clear that “there is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine”.
The number of “thromboembolic events in vaccinated people is no higher than that seen in the general population”, it added.
The Dalai Lama has received his first dose of the coronavirus vaccine while urging others eligible to “take this injection”.
“This is very very helpful, very good,” he said as he was given the Oxford-AstraZeneca vaccine at a facility in the Indian city of Dharamsala on March 6.
The Tibetan spiritual leader had enrolled himself to be vaccinated, officials said.
India launched its vaccination drive on January 16, but it was limited to healthcare workers and frontline staff.
Since March 1, however, the scheme has been extended to people aged over 60 and those between the ages of 45 and 59 with underlying illnesses.
Receiving his first shot in the northern state of Himachal Pradesh, the Dalai Lama said people needed to be vaccinated to “prevent some serious problems”.
The chief medical officer of Himachal Pradesh’s Kangra district, Dr. Gurdarshan Gupta, said the Dalai Lama had offered to visit the vaccination centre “like a common man”, Reuters reported.
“We arranged the session in the morning, considering the security concern,” he added.
India aims to cover 300 million “priority people” with its vaccination drive by the end of July.
Its drugs regulator has given the green light to two vaccines – one developed by AstraZeneca with Oxford University (Covishield) and one by Indian firm Bharat Biotech (Covaxin).
Indian PM Narendra Modi, 70, was among the first to get his vaccine shot.
Since the pandemic began, India has confirmed more than 11 million cases and over 157,000 deaths.
Much of the country has reported a sharp fall in cases recently – with daily infections for the county falling to less than 20,000 from a peak of over 90,000 in September.
However, a handful of states have recently reported a sharp increase in the number of cases.
Italy has blocked the export of an Oxford-AstraZeneca Covid vaccine shipment to Australia.
The decision affects 250,000 doses of the vaccine produced at an AstraZeneca facility in Italy.
Italy is the first EU country to use the bloc’s new regulations allowing exports to be stopped if the company providing the vaccines has failed to meet its obligations to the EU.
Australia said losing “one shipment” would not badly affect its rollout.
However, it has asked the European Commission, which reportedly backs Italy’s move, to review the decision.
AstraZeneca is on track to provide only 40% of the agreed supply to member states in the first quarter of the year. The company has cited production problems for the shortfall.
In January, then Italian PM Giuseppe Conte described delays in vaccine supplies by both AstraZeneca and Pfizer as “unacceptable” and accused the companies of violating their contracts.
The EU has been widely criticized for the slow pace of its vaccination program.
Under the EU vaccine scheme, which was established in June 2020, the bloc has negotiated the purchase of vaccines on behalf of member states.
There has been no official comment on the Italian move by the EU or AstraZeneca.
Australia began its vaccination program last week using the Pfizer/BioNTech vaccine. It was due to start inoculations with the AstraZeneca vaccine on March 5.
Italy approached the European Commission last week to say that it was its intention to block the shipment.
In a statement on March 4, the foreign ministry explained the move, saying it had received the request for authorization on February 24.
It said that previous requests had been given the green light as they included limited numbers of samples for scientific research, but the latest one – being much larger, for more than 250,000 doses – was rejected.
It explained the move by saying that Australia was not on a list of “vulnerable” countries, that there was a permanent shortage of vaccines in the EU and Italy, and that the number of doses was high compared with the amount given to Italy and to the EU as a whole.
Australia’s Health Minister Greg Hunt said: “Australia has raised the issue with the European Commission through multiple channels, and in particular we have asked the European Commission to review this decision.”
Australia had already received a shipment of 300,000 doses and planned to begin local production next month.
The Oxford-AstraZeneca coronavirus vaccine will be tested on children aged between 6 and 17 in a new trial.
Some 300 volunteers will take part, with the first vaccinations in the trial taking place later in February.
Researchers say they will assess whether the vaccine produces a strong immune response in children aged between six and 17.
The vaccine is one of two being used to protect against serious illness and death from Covid-19 in the UK, along with the Pfizer-BioNTech vaccine.
As many as 240 children will receive the vaccine – and the others a control meningitis vaccine – when the trial gets under way.
Volunteers who live near one of the four study sites – the University of Oxford, St George’s University Hospital, London, University Hospital Southampton and Bristol Royal Hospital for Children – are being asked to sign up.
Those interested in taking part must complete a short questionnaire.
Andrew Pollard, professor of pediatric infection and immunity, and chief investigator on the Oxford vaccine trial, noted that most children were relatively unaffected by Covid and were unlikely to become unwell with the virus.
However, Prof. Pollard said it was important to establish the safety and immune response to the vaccine in children and young people as some children might benefit from vaccination.
There are currently no plans for children to be vaccinated with the Oxford-Astrazeneca vaccine in the UK, as it has only been authorized to prevent Covid-19 in people aged 18 or over.
The Pfizer-BioNTech vaccine is only authorized in those aged over 16. The vaccine priority list also excludes anyone under the age of 16, even the clinically extremely vulnerable.
The University of Oxford said it was the first trial of a Covid vaccine in the 6 to 17 age group. It said other trials had begun but only measuring efficacy in those aged 16 and 17.
France has restricted the use of AstraZeneca’s Covid-19 vaccine to people under age of 65.
The move is the latest recommendation from an EU member state approving the vaccine with such restrictions, citing insufficient data on its efficacy for older people.
The European Medicines Agency (EMA), the EU drugs regulator, has approved the Oxford-AstraZeneca vaccine for all adults, but it is up to each member to set its own rollout policy.
Germany and Austria have already recommended the vaccine be limited to under-65s.
There has been criticism of the slow pace of vaccinations in the EU and the campaign has been hit by delays to deliveries of the AstraZeneca and Pfizer vaccines, among others.
The European Commission – the EU executive – was caught up in a row with AstraZeneca last week, after the company said it could not supply the expected doses on time.
The president of the Commission, Ursula von der Leyen, in particular, has been under fire for her own handling of the rollout, but she defended her stance on February 2.
Ursula von der Leyen told France’s Le Monde: “I am convinced that the European strategy on vaccination is the right one.”
German Chancellor Angela Merkel also backed the EU’s approach in a TV interview.
France’s health regulator said there was still not enough data about the effectiveness of the AstraZeneca vaccine for patients over 65 years of age.
“These data will arrive in the coming weeks. In the meantime we recommend its use for people under 65 years old,” it said.
It recommended the vaccine for health workers and vulnerable people between the ages of 50 and 65.
More than 1.5 million people have received a Covid vaccine so far in France.
Last week Germany’s vaccine commission said it could not recommend the use of the vaccine in people aged over 65.
On February 2, health authorities in Sweden and Poland made similar announcements and Belgium’s health minister said the vaccine, for the moment, would only be given to people below the age of 55. Italy’s medicines agency on Saturday also approved the jab for all adults under 55.
In a study yet to be formally published, scientists at Oxford University have said the vaccine could lead to a “substantial” fall in the spread of the virus.
Individual EU countries are free to decide who vaccines should be given to once they have been approved at EU level.
In her TV interview on Tuesday, German Chancellor Angela Merkel said “every vaccine is welcome in the European Union”, adding that good data had emerged for the Russian Sputnik V vaccine.
In her interview with Le Monde, Ursula von der Leyen admitted that the EU had made missteps.
She said: “When you make urgent decisions – and in this year of crisis we’ve taken around 900 – there’s always the chance of missing something.”
However, Ursula von der Leyen said 18 million vaccine doses had been delivered across the EU so far and many more would follow over the next two months.
No-one who received the Oxford vaccine in trials was hospitalized or became seriously ill due to Covid-19.
AstraZeneca’s vaccine is given via two injections to the arm, the second between 4 and 12 weeks after the first.
When it approved it last week, the EMA noted that most participants in test studies were under 55 years of age.
The agency said that while there were not yet enough results to show how well the vaccine will work in older people, “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines”.
AstraZeneca has said a US study will shortly provide additional data on the vaccine’s efficacy in older adults.
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