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Germany, Italy, Spain to restart AstraZeneca shot; EU regulator says 'benefits outweigh risks'

 A medical worker holds a vial of the AstraZeneca COVID-19 vaccine. File Photo by Luong Thai Linh/EPA-EFE
 A medical worker holds a vial of the AstraZeneca COVID-19 vaccine. File Photo by Luong Thai Linh/EPA-EFE

March 18 (UPI) -- Germany, Italy, Spain and other European nations that had halted administering the AstraZeneca COVID-19 vaccine over reports of blood clotting announced Thursday the resumption of their inoculation campaigns after the European and British drug regulators said the benefits of the shot far outweigh its risks.

More than a dozen European countries had temporarily suspended administering the AstraZeneca COVID-19 vaccine after Norway announced a small number of cases of clotting and bleeding over the weekend, and said they were awaiting the results of an investigation by the European Medicines Agency before making any further decisions.

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On Thursday, both the EMA's Pharmacovigilance Risk Assessment Committee and Britain's Medicines and Healthcare Products Regulator Agency separately said the vaccine developed by AstraZeneca and Oxford University is not associated with an increased risk in blood clots in those who receive it.

"The benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects," it said in a statement on its preliminary review of such cases.

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The British-Swedish firm AstraZeneca, which has been standing by its drug amid its cessation said Thursday following the reports that the two regulators reaffirmed its efficacy and safety.

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"Vaccine safety is paramount and we welcome the regulators' decisions, which affirm the overwhelming benefit of our vaccine in stopping the pandemic," Ann Taylor, chief medical officer at AstraZeneca, said in a statement. "We trust that, after the regulators' careful decisions, vaccinations can once again resume across Europe."

Following the announcement by the EMA, Germany, Italy and Cyprus announced they would be restarting their campaigns on Friday while Spain said it would resume its inoculations with the drug on Wednesday.

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"It was right to suspend vaccination with AstraZeneca as a precaution until the noticeable accumulation of cases of this very rare type of thrombosis had been analyzed," Jens Spahn, Germany's minister of health, said during a press conference Thursday. "Doctors need to know so that they can inform those who want to be vaccinated."

Italian Prime Minister Mario Draghi announced the resumption of its AstraZeneca vaccination rollout in a brief statement, saying "[t]he government's priority remains that of carrying out the greatest number of vaccinations in the shortest possible time."

On Wednesday, Draghi's office said he had spoken with French President Emmanuel Macron and they agreed if the EMA analysis came back positive "the two leaders are ready to promptly restart administration of the AstraZeneca vaccine."

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However, Norway, Sweden and Denmark said they will maintain their temporary suspension.

"We take EMA's assessment into account," Geir Bukholm, director of the division of Infection Control at the Norway Institute of Public Health, said in a statement. "Due to the situation with several serious cases in Norway, we want to thoroughly review the situation before we make a conclusion. This will take some time."

Denmark said that since the EMA could not rule out the possibility of a link between a few cases of rare but severe blood clots to the vaccination, its hold would stand with its health authorities to "assess the impact of EMA's review" on its vaccination program.

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A total of 469 thromboembolic events following inoculations, 191 of which were within the European Economic Area, have been reported, which is lower than what is observed in the general population, the European regulator said in its preliminary findings on Thursday.

"This allows the PRAC to confirm that there is no increase in overall risk of blood clots," it said.

Some 20 million people in Britain and the EEA have received the shot as of Tuesday.

The regulator said, however, the vaccine may be associated with low levels of blood platelets though "these are rare cases" with the EMA only receiving seven reports of blood clots in multiple blood vessels and 18 cases of clots in the vessels draining blood from the brain.

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Nine of these cases resulted in death, and almost all cases were women under the age of 55.

The opinion of the PRAC is the vaccine's proven efficacy in preventing COVID-19 hospitalization and death outweighs "the extremely small likelihood" of developing these two potential side effects though patients should be aware of the remote possibility of developing such syndromes, it said.

The Medicines and Healthcare Products Regulatory Agency said in a statement Thursday that it came to similar findings, which the government's independent advisory group, the Commission on Human Medicines, confirmed.

The regulator issued the recommendation after five men, ages 19-59, developed rare blood clotting in the brain with low levels of platelets and one of them died, the MHRA told Bloomberg.

The MHRA said in its statement that this type of rare blood clotting has been reported in fewer than one in a million people vaccinated so far in Britain, and "can also occur naturally," so "a causal association with the vaccine has not been established."

"We have received a very small number of reports of an extremely rare form of blood clot in the cerebral veins (sinus vein thrombosis, or CSVT) occurring together with lowered platelets soon after vaccination," MHRA Chief Executive Dr. June Raine said in a statement. "This type of blood clot can occur naturally in people who have not been vaccinated, as well as in those suffering from COVID-19."

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The regulator added that further review of the five British reports of rare blood clotting is ongoing.

Prior to the regulators' reports being released, the World Health Organization released a statement Wednesday in support of the vaccine.

"At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue," the U.N. health body said.

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