AstraZeneca says US trial data shows vaccine is 79 per cent effective, finds no blood clot concerns
- Vaccine maker says late-stage US study shows strong protection and no increased risk of a rare blood clot identified in Europe
- A US FDA advisory committee will now publicly debate the evidence behind the shots before the agency decides whether to allow emergency use
Although AstraZeneca’s vaccine has been authorised in more than 50 countries, it has not yet been given the green light in the US. The US study comprised more than 30,000 volunteers, of whom two-thirds were given the vaccine while the rest got dummy shots.
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“These findings reconfirm previous results observed,” said Ann Falsey of the University of Rochester School of Medicine, who helped lead the trial. “It’s exciting to see similar efficacy results in people over 65 for the first time.”
Julian Tang, a virologist at the university of Leicester who was unconnected to the study, described it as “good news” for the AstraZeneca vaccine.
“The earlier, Brazil, South Africa trials had a more variable and inconsistent design and it was thought that the US FDA would never approve the use of the AZ vaccine on this basis, but now the US clinical trial has confirmed the efficacy of this vaccine in their own clinical trials,” he said.
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The early findings from the US study are just one set of information AstraZeneca must submit to the Food and Drug Administration. An FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether to allow emergency use of the vaccine.
Scientists have been awaiting results of the US study in hopes it will clear up some of the confusion about just how well the shots really work.
Britain first authorised the vaccine based on partial results from testing in the United Kingdom, Brazil and South Africa that suggested the shots were about 70 per cent effective. But those results were clouded by a manufacturing mistake that led some participants to get just a half dose in their first shot – an error the researchers did not immediately acknowledge.
Then came more questions, about how well the vaccine protected older adults and how long to wait before the second dose. Some European countries including Germany, France and Belgium initially withheld the shot from older adults and only reversed their decisions after new data suggested it is offering seniors protection.
Coronavirus: Denmark, Norway and Iceland suspend use of AstraZeneca vaccine over blood clot fears
AstraZeneca’s vaccine development was rocky in the US, too. Last fall, the Food and Drug Administration suspended the company’s study in 30,000 Americans for an unusual six weeks, as frustrated regulators sought information about some neurologic complaints reported in Britain; ultimately, there was no evidence the vaccine was to blame.
Last week, more than a dozen countries, mostly in Europe, temporarily suspended their use of the AstraZeneca shot after reports it was linked to blood clots. On Thursday, the European Medicines Agency concluded after an investigation that the vaccine did not raise the overall risk of blood clots, but could not rule out that it was connected to two very rare types of clots.
US extends travel restrictions at land borders with Canada, Mexico
The US government has announced that the country’s land borders with North American neighbours Canada and Mexico will remain closed to non-essential travel for at least another month, through April 21, due to the ongoing Covid-19 pandemic.
The Department of Homeland Security reiterated that the goal of the extended border closures is to limit the spread of coronavirus, determining that non-essential travel still poses too great of a risk.
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“To prevent the further spread of Covid-19, and in coordination with our partners in Canada and Mexico, the United States is extending the restrictions on non-essential travel at our land borders through April 21, while ensuring continued flows of essential trade and travel,” the department said in a tweet published Thursday.
Canadian Public Safety Minister Bill Blair confirmed the extension, stating that the country will continue to base its decisions on the best public health information available.
Iceland reopens its border to Covid-19 vaccinated visitors
Iceland will reopen its borders to visitors who have received Covid-19 vaccines, with vaccinated visitors not having to undergo PCR testing or quarantines.
To qualify for entry into the country, travellers must “provide proof of full vaccination with a vaccine that has been certified for use by the European medical agency such as Pfizer, Johnson & Johnson’s single dose and Moderna vaccines, as well as requirements defined by the chief epidemiologist of Iceland and Icelandic regulations,” Visit Iceland said.
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Travellers must also provide documentation on prior infections meeting the chief epidemiologist’s requirements.
Previously, the only visitors allowed entry into Iceland were European Union/European Economic Area citizens with documentation of negative PCR tests before their departure to the country, followed by a negative test at the border. Those visitors were also required to quarantine for five days and undergo a third PCR test.
EU vaccine tsar signals Russia’s Sputnik shot isn’t needed
Covid-19 vaccine doses “are coming” and the European Union does not need Russia’s Sputnik V shot, according to the EU commissioner in charge of fixing the bloc’s vaccination drive.
Thierry Breton, the EU’s internal markets commissioner, pledged that 100 million doses would be delivered in April and said continental Europe could reach immunity by July 14, which is Bastille Day in France.
Meanwhile, Russians are “struggling to get their hands” on the Sputnik vaccine, Breton said in a French television interview. By contrast, German Chancellor Angela Merkel said her country might use Sputnik.
“Dear Commissioner Breton, please stop being biased. Europeans want a choice of safe and efficient vaccines, which you so far failed to provide. Sputnik V is already registered in 54 countries,” the Russian vaccine developer reacted in a series of tweets. “His comments pressure Sputnik V not to go through the EMA approval process because @ThierryBreton believes all is great with EU vaccinations and Sputnik V is not needed. Are Europeans happy with Breton’s vaccination approach?”
Most European countries resumed dispensing AstraZeneca shots Friday after a suspension to assess potential side effects, a setback for the EU’s vaccination campaign.
Asked about the EU’s comparatively slow vaccine roll-out, Breton insisted that Covid-related death rates were higher in Britain and in the US, which President Joe Biden said just met a goal of getting 100 million Americans inoculated.
Brazil clears use of full vaccine stock as first doses
Brazil said on Sunday that it was lifting its requirement for local authorities to reserve half their coronavirus vaccine stockpiles for second doses, seeking to accelerate its lagging immunisation campaign and curb a deadly Covid-19 surge.
Outgoing health minister Eduardo Pazuello said the goal of the policy switch was to get at least one vaccine dose to the maximum number of people as fast as possible.
Brazil, which has the second-highest death toll in the pandemic, is so far using the Oxford-AstraZeneca vaccine and Chinese-developed CoronaVac, both of which require two doses.
“By freeing the full stockpile of vaccines for immediate use, we will be able to double the number of doses applied this week, saving and protecting more lives,” Pazuello said in a statement.
The ministry said it had received guarantees from suppliers that enough vaccines would arrive to ensure all recipients receive their second dose on schedule.
