(CNN) — The global rollout of the Oxford-AstraZeneca Covid-19 vaccine has encountered another hurdle as a handful of countries paused their use of the shot following reports it could be connected to blood clots, despite no clear evidence of a link.
AstraZeneca has robustly defended its vaccine, saying Friday there was “no evidence of an increased risk” of blood clots, and European and UK medicines regulators have each said the link between the vaccine and blood clots has not been confirmed and that rollouts should continue.
After a group of European countries — including Denmark, Norway and Iceland — suspended use of the vaccine on Thursday, Thailand’s Prime Minister, Prayut Chan-o-cha, canceled plans to publicly get the AstraZeneca shot on Friday and the country also delayed its rollout.
“When there is an adverse event, we don’t need to be in rush,” said Piyasakol Sakolsatayadorn, a senior member of the country’s vaccination committee.
Bulgaria has become the latest country to suspend use of the vaccine on Friday pending investigations into safety. Prime Minister Boyko Borissov ordered a halt to all inoculation using the AstraZeneca Covid-19 vaccine until the European Medicines Agency “rejects all doubts” about the vaccine’s safety, according to a government statement.
The moves came in response to reports of blood clots in a few inoculated people in Denmark, including one fatality. Denmark was the first country to take the precautionary measure, announcing a 14-day break while authorities investigated further.
Norway and Iceland soon followed. The Norwegian Institute of Public Health said the country has also reported cases of blood clots shortly after receiving a Covid-19 vaccination in Norway but “mainly in the elderly where there is often another underlying disease as well.”
Other countries, including Austria and Italy, have suspended specific batches of the vaccine.
But a number of nations — including Germany, France, the UK, the Netherlands, Mexico and Nigeria — stood by the shot and reassured citizens of its safety.
Health agencies tell countries to keep rolling out
The European Medicines Agency (EMA) said Thursday that it did not recommend suspending use of the AstraZeneca vaccine, stating that there is “no indication” the vaccine caused the blood clots in the people who received the vaccine. The agency told countries they could keep rolling out the shot while investigations take place.
“The vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing,” the agency said.
The UK’s medicine regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — also issued a statement Thursday reassuring the public that the vaccine is still safe and that “people should still go and get their COVID-19 vaccine.”
The episode nonetheless poses another headache for the pharmaceutical giant, whose vaccine has been beset by political disputes, delivery delays and other concerns.
But the tone across most of Europe was one of calm, as other governments sought to put the reports into context.
“Investigations are carried out systematically each time serious adverse effects are declared,” France’s health minister Olivier Véran said in his weekly briefing on Thursday. “But what are we talking about? About 30 people out of more than five million Europeans having received an injection.”
The UK’s MHRA, where 11 million doses of the vaccine have been administered, said blood clots “can occur naturally and are not uncommon.” Its vaccines safety lead Phil Bryan added that the reports of blood clots “are not greater than the number that would have occurred naturally in the vaccinated population.”
And Germany confirmed late on Thursday that it would stick to its rollout plans. “We are planning to continue vaccinating with AstraZeneca, just like an overall majority of other European countries,” German health minister Jens Spahn said.
‘No evidence’ of clotting link
AstraZeneca said Friday that its analysis not only shows “no evidence of an increased risk” of blood clots in vaccine recipients, but demonstrates a lower number than in the general population.
“An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country with COVID-19 Vaccine AstraZeneca,” the company said in a statement.
“In fact, the observed number of these types of events are significantly lower in those vaccinated than would be expected among the general population,” it added.
Denmark’s health leaders had stressed their decision to announce a two-week pause on its use of the vaccine was a precautionary one, reminding people there is “good evidence that the vaccine is both safe and effective” but saying they would “act early” to investigate the reports of clotting.
Spain delayed giving the jab to those aged between 55 and 65 until a review is conducted, but Dutch health minister Hugo de Jonge said Thursday there is “no cause for concern,” and no reason to stop using the AstraZeneca vaccine.
Earlier this week, a number of EU nations paused the use of doses that came from a particular batch of AstraZeneca vaccine, after a 49-year-old woman in Austria died of multiple thrombosis on Sunday. The EMA said Wednesday there was “no indication” that vaccination had been behind the cases of clotting or death.
And on Thursday, Italian medicines agency AIFA also banned use of another batch of AstraZeneca vaccines. The agency said it was responding to “some serious adverse events” taking place around the time of vaccinations from one specific batch. It did not say what the events were and said no causal link between the events and the vaccine had been established.
Nigeria, which has started receiving millions of vaccine doses through the COVAX program, defended the vaccine Thursday, saying it is satisfied with the clinical evidence indicating the shot is “safe and effective” and urging its citizens to continue to participate in the rollout.
Real-world data has also shown that the vaccine is having a significant impact in reducing Covid-19 hospitalizations.
A single dose of the vaccine reduces the risk of hospitalization from Covid-19 by more than 80% in people aged over 80, data from Public Health England showed earlier this month. The vaccine is given in two doses, though countries differ in how far apart they are spreading those shots.
Concerns about the vaccine’s safety nonetheless come at an awkward time for AstraZeneca, with disputes over its supplies to the EU still unresolved. After announcing it would pause the vaccine, Denmark’s health authority said Thursday the country would now receive approximately 900,000 fewer doses of the shot.
“The fact that AstraZeneca is once again downgrading the number of doses delivered to the EU and thus Denmark is, of course, both unsatisfactory and a serious challenge,” Ole Jensen, deputy director at the Statens Serum Institut, said.
Polish officials also announced on Friday that AstraZeneca will reduce the number of coronavirus vaccine doses delivered there.
CANADA STOCKS – TSX falls 0.14% to 19,201.28
* The Toronto Stock Exchange’s TSX falls 0.14 percent to 19,201.28
* Leading the index were Stantec Inc <STN.TO>, up 3.4%, Imperial Oil Ltd, up 3.3%, and Corus Entertainment Inc, higher by 2.9%.
* Lagging shares were Aphria Inc, down 14.2%, Village Farms International Inc, down 9.9%, and Aurora Cannabis Inc, lower by 9.4%.
* On the TSX 91 issues rose and 134 fell as a 0.7-to-1 ratio favored decliners. There were 24 new highs and no new lows, with total volume of 228.0 million shares.
* The most heavily traded shares by volume were Toronto-dominion Bank, Royal Bank Of Canada and Suncor Energy Inc.
* The TSX’s energy group fell 0.32 points, or 0.3%, while the financials sector climbed 2.46 points, or 0.7%.
* West Texas Intermediate crude futures rose 0.52%, or $0.31, to $59.63 a barrel. Brent crude rose 0.4%, or $0.25, to $63.2 [O/R]
* The TSX is up 10.1% for the year.
Air Canada signs C$5.9 billion government aid package, agrees to buy Airbus, Boeing jets
By David Ljunggren and Allison Lampert
OTTAWA/MONTREAL (Reuters) -Air Canada, struggling with a collapse in traffic due to the COVID-19 pandemic, reached a deal on Monday on a long-awaited aid package with the federal government that would allow it to access up to C$5.9 billion ($4.69 billion) in funds.
The agreement – the largest individual coronavirus-related loan that Ottawa has arranged with a company – was announced after the airline industry criticized Prime Minister Justin Trudeau’s Liberal government for dawdling. The United States and France acted much more quickly to help major carriers.
Canada‘s largest carrier, which last year cut over half its workforce, or 20,000 jobs, and other airlines have been negotiating with the government for months on a coronavirus aid package.
In February, Air Canada reported a net loss for 2020 of C$4.65 billion, compared with a 2019 profit of C$1.48 billion.
As part of the deal, Air Canada agreed to ban share buybacks and dividends, cap annual compensation for senior executives at C$1 million a year and preserve jobs at the current level, which is 14,859.
It will also proceed with planned purchases of 33 Airbus SE 220 airliners and 40 Boeing Co 737 MAX airliners.
Chris Murray, managing director, equity research at ATB Capital Markets, said the deal took into account the “specific needs of Air Canada in the short and medium term without being overly onerous.”
He added: “It gives them some flexibility in drawing down additional liquidity as needed.”
Transport Minister Omar Alghabra said the government was still in negotiations with other airlines about possible aid.
Canada, the world’s second-largest nation by area, depends heavily on civil aviation to keep remote communities connected.
Opposition politicians fretted that further delays in announcing aid could result in permanent damage to the country.
Air Canada said it would resume services on nearly all of the routes it had suspended because of COVID-19.
‘SIGNIFICANT LAYER OF INSURANCE’
The deal removes a potential political challenge for the Liberals, who insiders say are set to trigger an election later this year.
The government has agreed to buy C$500 million worth of shares in the airline, at C$23.1793 each, or a 14.2% discount to Monday’s close, a roughly 6% stake.
“Maintaining a competitive airline sector and good jobs is crucially important,” Finance Minister Chrystia Freeland told reporters, adding the equity stake would allow taxpayers to benefit when the airline’s fortunes recovered.
The Canadian government previously approved similar loans for four other companies worth up to C$1.billion, including up to C$375 million to low-cost airline Sunwing Vacations Inc. The government has paid out C$73.47 billion under its wage subsidy program and C$46.11 billion in loans to hard-hit small businesses.
Michael Rousseau, Air Canada‘s president and chief executive officer, said the liquidity “provides a significant layer of insurance for Air Canada.”
Jerry Dias, head of the Unifor private-sector union, described the announcement as “a good deal for everybody.”
Unifor represents more than 16,000 members working in the air transportation sector.
But the Canadian Union of Public Employees, which represents roughly 10,000 Air Canada flight attendants, said the package protected the jobs of current workers rather than the 7,500 members of its union who had been let go by the carrier.
($1=1.2567 Canadian dollars)
(Reporting by David Ljunggren in Ottawa and Allison Lampert in Montreal; Additional reporting by Julie Gordon in Ottawa and Munsif Vengattil in Bengaluru; Editing by Dan Grebler and Peter Cooney)
U.K. advises limiting AstraZeneca in under-30s amid clot worry
British authorities recommended Wednesday that the AstraZeneca COVID-19 vaccine not be given to adults under 30 where possible because of strengthening evidence that the shot may be linked to rare blood clots.
The recommendation came as regulators both in the United Kingdom and the European Union emphasized that the benefits of receiving the vaccine continue to outweigh the risks for most people — even though the European Medicines Agency said it had found a “possible link” between the shot and the rare clots. British authorities recommended that people under 30 be offered alternatives to AstraZeneca. But the EMA advised no such age restrictions, leaving it up to its member-countries to decide whether to limit its use.
Several countries have already imposed limits on who can receive the vaccine, and any restrictions are closely watched since the vaccine, which is cheaper and easier to store than many others, is critical to global immunization campaigns and is a pillar of the UN-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.
“This is a course correction, there’s no question about that,” Jonathan Van-Tam, England’s deputy chief medical officer, said during a press briefing. “But it is, in a sense, in medicine quite normal for physicians to alter their preferences for how patients are treated over time.”
Van-Tam said the effect on Britain’s vaccination timetable — one of the speediest in the world — should be “zero or negligible,” assuming the National Health Service receives expected deliveries of other vaccines, including those produced by Pfizer and Moderna.
EU and U.K. regulators held simultaneous press conferences Wednesday afternoon to announce the results of investigations into reports of blood clots that sparked concern about the rollout of the AstraZeneca vaccine.
The EU agency described the clots as “very rare” side effects. Dr Sabine Straus, chair of EMA’s Safety Committee, said the best data is coming from Germany where there is one report of the rare clots for every 100,000 doses given, although she noted far fewer reports in the U.K. Still, that’s less than the clot risk that healthy women face from birth control pills, noted another expert, Dr. Peter Arlett.
The agency said most of the cases reported have occurred in women under 60 within two weeks of vaccination — but based on the currently available evidence, it was not able to identify specific risk factors. Experts reviewed several dozen cases that came mainly from Europe and the U.K., where around 25 million people have received the AstraZeneca vaccine.
“The reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine,” said Emer Cooke, the agency’s executive director. “The risk of mortality from COVID is much greater than the risk of mortality from these side effects.”
Arlett said there is no information suggesting an increased risk from the other major COVID-19 vaccines.
The EMA’s investigation focused on unusual types of blood clots that are occurring along with low blood platelets. One rare clot type appears in multiple blood vessels and the other in veins that drain blood from the brain.
While the benefits of the vaccine still outweigh the risks, that assessment is “more finely balanced” among younger people who are less likely to become seriously ill with COVID-19, the U.K’s Van-Tam said.
“We are not advising a stop to any vaccination for any individual in any age group,” said Wei Shen Lim, who chairs Britain’s Joint Committee on Vaccination and Immunization. “We are advising a preference for one vaccine over another vaccine for a particular age group, really out of the utmost caution rather than because we have any serious safety concerns.”
In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine.
Britain, which relies heavily on AstraZeneca, however, continued to use it.
The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.
Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee, said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences.
“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.
In some countries, authorities have already noted hesitance toward the AstraZeneca shot.
“People come and they are reluctant to take the AstraZeneca vaccine, they ask us if we also use anything else,” said Florentina Nastase, a doctor and co-ordinator at a vaccination centre in Bucharest, Romania. “There were cases in which people (scheduled for the AstraZeneca) didn’t show up, there were cases when people came to the centre and saw that we use only AstraZeneca and refused (to be inoculated).”
Meanwhile, the governor of Italy’s northern Veneto region had said earlier Wednesday that any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot.
“If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters.
The latest suspension of AstraZeneca came in Spain’s Castilla y Leon region, where health chief Veronica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary.
French health authorities had said they, too, were awaiting EMA’s conclusions, as were some officials in Asia.
On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.
The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review.
But some experts urged perspective. Prof Anthony Harnden, the deputy chair of Britain’s vaccination committee, said that the program has saved at least 6,000 lives in the first three months and will help pave the way back to normal life.
“What is clear it that for the vast majority of people the benefits of the Oxford AZ vaccine far outweigh any extremely small risk,” he said. “And the Oxford AZ vaccine will continue to save many from suffering the devastating effects that can result from a COVID infection.”