EU regulator: AstraZeneca vaccine safe – US to Send Vaccine to Mexico, Canada – World Covid Stats

The top drug regulator for the European Union announced Thursday that AstraZeneca’s coronavirus vaccine is safe and effective to use, after over a dozen countries halted administering its use over concern of blood clots.

However, the European Medicines Agency (EMA) also said it could not rule out a link to the blood clots, and said it would add a warning to the product in order to draw attention to the possibility of such rare side effects.

Including the warning and conducting outreach to health professionals and the public “will help to spot and mitigate any possible side effects,” said Emer Cooke, the executive director of the agency.

The EMA said the benefits of protecting people against COVID-19 with a vaccine far outweigh possible risks.

More than a dozen countries in Europe have temporarily suspended use of the vaccine, including Germany, France, Italy, Spain, Ireland, Norway and Denmark. They have been waiting on the EMA’s recommendations on how to proceed.

“Our scientific position is that this vaccine is a safe and effective option to protect citizens against COVID-19,” Cooke said. “We made this review our highest priority.”

The EMA published its findings, noting that out of about 20 million people who received the vaccine, there were only seven cases of blood clots in multiple blood vessels and 18 cases of blood clots in the brain.

“A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the agency said.

The EMA investigation was focused on a small number of brain clots that have been reported following vaccinations. Most of these occurred in people under 55 and the majority were women.

The World Health Organization earlier this week endorsed the safety of the shot, and the United Kingdom’s top medical regulator on Thursday gave a similar message, urging countries to continue offering the shot.

But even if countries resume vaccinations immediately, experts think some damage has already been done.

Not only could the pauses set back vaccination efforts across Europe, but they could have ripple effects across the world and undermine confidence in the vaccine.

Hundreds of millions of Europeans are facing the prospect of another strict lockdown as the continent struggles with a new wave of COVID-19 infections and a flawed vaccine rollout. The fallout from suspending AstraZeneca’s shots could slow it down even more.

Tal Axelrod contributed to this story

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Italy, France, Germany and several other countries will resume administering AstraZeneca jabs from Friday after Europe’s medicines regulator said the vaccine was “safe and effective” and its benefits outweighed its risks.

Portugal will resume on Monday, Spain and the Netherlands next week, while Sweden’s public health agency said it would take “a few days” to decide.

The European Medicines Agency (EMA) had launched a review after about 30 cases of unusual blood clotting and low platelet counts in recipients of the vaccine prompted more than a dozen EU countries to suspend its use.

The EMA’s director, Emer Cooke, said the agency’s safety committee had reached “a clear scientific conclusion” and had not found that the vaccine was associated with an increase in the overall risk of blood clots.

However, it did uncover “a small number of cases of rare and unusual but very serious clotting disorders”, and Cooke said the EMA could “not rule out definitively a link between these cases and the vaccine”, which was being investigated.

A warning in the vaccine information would draw attention to “possible rare conditions” to help recipients and healthcare professionals “prevent and mitigate any possible side-effects”, she said.

Covid vaccine side-effects: what are they, who gets them and why?

Several EU countries embarking on a third wave of coronavirus driven by more infectious new variants and struggling to accelerate sluggish inoculation programmes welcomed the decision. Italy’s prime minister, Mario Draghi, said AstraZeneca vaccinations would resume on Friday. Germany’s health minister, Jens Spahn, made a similar announcement, as did Cyprus, Latvia, Lithuania and Slovenia.

The French prime minister, Jean Castex, said he would get vaccinated on Friday to set an example.

Cooke said: “We have vaccines that can prevent death and hospitalisation. We need to use them. A lot of member states are waiting for the outcome of this safety review. Countries can now make an informed decision so as to the safety of the vaccine.”

Austria, the Baltic states, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and Sweden, along with non EU-member Norway, were among the European countries to either pause use of the vaccine or ban specific batches.

Cooke said investigations were continuing into the rare events, but she added: “About 7 million people have now been vaccinated in the EU with the AstraZeneca vaccine, and 11 million in the UK … I want to reiterate that our scientific position is that this vaccine is a safe and effective option to protect citizens against Covid-19.”

She said the agency’s investigation to date had not uncovered any problems related to specific batches of the shot or manufacturing sites. “If it was me, I would be vaccinated tomorrow,” she said. “But I would want to know what to do if I had any problems – and that’s what we’re doing now.”

Britain’s medicines regulator the MHRA also said the evidence did not suggest that the AstraZeneca vaccine caused blood clots, but it too was still investigating a very rare and specific type of blood clot in cerebral veins.

The MHRA said there had been five cases of cerebral venous sinus thrombosis (CVST) combined with a low platelets count in recipients of the vaccine in the UK, and there was no need to pause inoculations.

A British expert, Prof Sir Munir Pirmohamed, who chairs the Commission on Human Medicines, said that even if a link between CVST and the shot was found, it was unlikely the UK vaccination campaign would be halted since the incidence rate was so low.

Norway’s expert group said on Thursday that after investigating the cases of three health workers who had fallen ill with the same combination of CVST and low platelet counts, one of whom died, they believed a strong immune reaction to the vaccine was the cause.

“We have no other history in these patients that could give such a strong immune response,” Prof Pål Andre Holme said. “I am absolutely certain it is these antibodies that are the cause and see no other reason than … the vaccine that triggers it.”

The World Health Organization’s global vaccine safety panel is examining the vaccine data and the precise clinical circumstances of each rare blood coagulation case and will publish its findings on Friday.

AstraZeneca has said the number of cases of blood clots reported “is lower than the hundreds of cases that would be expected among the general population”.

Denmark, the first country to suspend the shot last week after a 60-year-old woman died from a “highly unusual” blood event, and Germany, where three recipients have died from the rare cerebral vein thrombosis, have said they acted on strictly scientific grounds.

Because of the extreme rarity of the events, the decision to pause the shot has been criticised as political, with Belgium saying it was “irresponsible”.

The AstraZeneca vaccine was already perceived by many in the EU as second best after several national agencies postponed its authorisation for the over-65s because of a lack of data. Experts fear the suspensions may further depress its take-up.

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President Biden’s administration plans to send millions of doses of the AstraZeneca COVID-19 vaccine to Mexico and Canada, the White House confirmed Thursday, a development that comes as the U.S. faces a surge of migrants at the southern border with Mexico.

Press secretary Jen Psaki confirmed the plans, which were first reported by Reuters and The Washington Post, but said that they were not yet finalized.

“Our first priority remains vaccinating the U.S. population, but the reality is the pandemic knows no borders,” Psaki told reporters. “Ensuring our neighbors can contain the virus is mission critical to ending the pandemic.”

Psaki said that officials are working to finalize plans to give Mexico 2.5 million doses and give Canada 1.5 million doses of the AstraZeneca vaccine, which has not yet been approved in the United States. She said that the U.S. has 7 million “releasable” doses of AstraZeneca vaccine in total and suggested the administration could share extras with other countries in the future.

“Balancing the need of letting the approval process play out of the AstraZeneca vaccine as it is taking place in the U.S. with the importance of helping stop the spread in other countries, we are assessing how we can loan doses,” she said. “That is our aim, it is not fully finalized yet but that is our aim and what we’re working toward.”

The plans coincide with an effort by the administration to get a handle on the surge of migrants at the southern border. Homeland Security Secretary Alejandro Mayorkas said in a statement early this week that the number of attempted crossings there is on pace to reach its highest level in two decades.

Asked Thursday whether the vaccine announcement had anything to do with conversations about addressing the border crisis, Psaki suggested the two issues were not related.

“There have been expectations set outside of, unrelated to any vaccine doses or requests for them that they would be partners in dealing with the crisis on the border. And there have been requests, unrelated, for doses of these vaccines. Every relationship has multiple layers of conversations that are happening at the same time,” she said.

The agreement is not expected to impact Biden’s plan to make the vaccine available to all U.S. adults by the end of May.

It comes after Mexican President Andrés Manuel López Obrador and Canadian Prime Minister Justin Trudeau requested vaccine doses from the U.S. Mexico and Canada will be expected to pay back the U.S. with doses later this year, according to Reuters.

On the border issue, Mexico has vowed to take back more Central American families “expelled” while the U.S. has an emergency health order in place, the Post reported.

Biden had previously said his officials were “talking with several countries” about the United States’ supply of the AstraZeneca vaccine, which has not yet been approved by the Food and Drug Administration.

The president had said his priority is to vaccinate Americans and ensure the pandemic is under control in the U.S. before helping other countries. But he noted, “If we have a surplus, we’re going to share it with the rest of the world.”

Brett Samuels contributed.

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