Tag Archives: European Medicines Agency (EMA)

European countries may have to mix COVID-19 shots amid AstraZeneca crisis

By Matthias Blamont, Gwladys Fouche and Essi Lehto

PARIS (Reuters) – Several European countries are considering mixing up COVID-19 vaccines for citizens who received a first dose of AstraZeneca’s shot, an unprecedented move that highlights challenges for governments struggling to tame fresh rises in infections.

Vaccination programs have been upset after a small number of reports that recipients of the AstraZeneca inoculation have suffered extremely rare blood clots, leading some countries worldwide to suspend its use out of caution.

A senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday there was a link between the vaccine and rare blood clots in the brain but the possible causes were still unknown.

The EMA later said in a statement that its review of the vaccine was ongoing. It will give an update on its investigation on Wednesday afternoon.

AstraZeneca has said previously its studies have found no higher risk of clots because of the vaccine, millions of doses of which have been administered worldwide.

While many countries have resumed using the shot, some have imposed age restrictions.

In many instances, this has left officials scratching their heads over what to do for people who received a first dose of AstraZeneca but are no longer eligible under the new rules.

While the numbers are small compared with the tens of millions being inoculated across the region, the decision is significant because it has not been tested in late-stage human trials.

Any divergence to the EMA’s marketing authorization would also be considered as “off label use”, meaning it would not be approved by the regulator and leave individual countries responsible for any possible side-effects.

The EMA had no immediate comment when asked about mixing and matching vaccines and referred to the briefing later on Wednesday.

Some experts say that, because all of the vaccines target the same outer “spike” protein of the virus, they could work together to train the body to fight off the virus. There is no evidence it will be as effective.

Germany was the first European country to recommend on April 1 that people under 60 who have had a first AstraZeneca shot should receive a different product for their second dose.

Norway will decide whether to resume using AstraZeneca’s vaccine or rely on alternatives by April 15.

“The outcome is either you get one vaccine, the AstraZeneca vaccine … or you get a booster vaccine with other types of vaccines,” Sara Viksmoen Watle, a senior physician at the Norwegian Institute of Public Health, told Reuters.

Norwegian authorities are also waiting for the results of a British trial launched in February to explore mixing doses of Pfizer and AstraZeneca vaccines. The timing of the data is not known.

Britain said late last year it would allow people to be given shots of different COVID-19 vaccines on rare occasions, but it has not yet had to do so.

Finland, which resumed using the AstraZeneca vaccine from March 29, but will only give it to people aged 65 and over, said it would wait for the EMA’s conclusions before making a recommendation. It will have to start giving second doses by mid-April.

In France, where the vaccine can now only be used for those aged 55 or older, the issue affects hundreds of thousands of people.

A top health advisory body in charge of defining the use of vaccines, the Haute Autorité de la Santé (HAS), is also contemplating deploying a messenger RNA (mRNA) vaccine produced by Pfizer-BioNTech or Moderna as a second dose, according to two sources aware of the organization’s plans.

A formal decision has not been yet taken, however, as experts await more data, notably from Britain, one of the sources added. France has until early May, which marks 12 weeks after the first doses were administered.

The HAS had no comment.

Back in February, it said there was no data to assess interchangeability of AstraZeneca’s vaccine and therefore advised that those who had already received a first dose should not get a different shot when vaccinated for the second time.

“We are left guessing and that makes me and other colleagues feel very uncomfortable,” said Charlotte Senechal, a 52-year-old hospital nurse working in Strasbourg, eastern France.

WHO tries to quash nervousness about AstraZeneca vaccine

By Emma Farge and Emilio Parodi

GENEVA/MILAN/SOFIA (Reuters) – The World Health Organization squarely endorsed AstraZeneca’s coronavirus vaccine on Friday, as Thailand joined a number of smaller European countries in suspending use of the shot because of sporadic reports of blood clots among recipients.

Bulgaria also joined Denmark, Norway and Iceland, which all stopped using the vaccine on Thursday. Austria, Italy, Luxembourg, Estonia, Lithuania and Latvia stopped using certain batches.

“Until all doubts are dispelled…, we are halting inoculations with this vaccine,” Bulgarian Prime Minister Boyko Borissov said.

His health minister, Kostadin Angelov, said a 57-year-old woman had died of heart failure 15 hours after receiving an AstraZeneca shot, but urged those already inoculated to stay calm.

“We do not have any official data that proves a causal connection,” he said.

That line was reinforced by the WHO, which is keenly aware that AstraZeneca’s shot is by far the cheapest and most high-volume launched so far, and set to be the mainstay of vaccination programs in much of the developing world.

Spokeswoman Margaret Harris said the vaccine was “excellent”.

“It’s very important to understand that, yes, we should continue to be using the AstraZeneca vaccine,” she told a briefing. “All that we look at is what we always look at: Any safety signal must be investigated.”

The EU regulator, the European Medicines Agency (EMA), said on Wednesday that there had been 22 reports of embolisms from blood clots among 3 million people who had received the vaccine – no more than in the general population – but Bulgaria said it wanted to see that guidance in written form.

‘THIS NEEDS TO BE EXPLAINED’

Experts point to the difficulty of putting risks in perspective for a wider public that may be spooked by negative headlines.

In Sicily, where two people died shortly after being vaccinated, the regional health administrator said 7,000 inoculation appointments had been cancelled as a result.

Silvestro Scotti, a family doctor in Naples and head of the Italian Federation of General Practitioners, said he had been bombarded all day with inquiries from people nervous about getting the AstraZeneca shot.

“The crazy thing is that, even if the correlation between the vaccine and blood clots were proved, it would be a rate of 0.007 out of a thousand,” he said.

“To give an example: the birth control pill, which is used widely and doesn’t worry anyone, has a proven risk rate of 0.6 in a thousand. Even in the worst-case scenario, the risk/benefit ratio for this vaccine is extraordinarily favorable. That needs to be explained to people.”

The WHO’s Harris said 268 million doses of COVID-19 vaccines from various developers had been administered worldwide without being shown to have caused a single death.

In France, where distrust of vaccination is long-established, only 43% said they trusted the AstraZeneca shot in a Harris Interactive poll conducted on March 11-12, while 55% said they trusted COVID-19 vaccines in general.

Germany has also had to contend with substantial skepticism, to the extent that Health Minister Jens Spahn suggested that the AstraZeneca shot be given to the police force and army, after some health and other frontline workers baulked at receiving it.

However, German authorities’ main concern has been lack of supply, rather than lack of acceptance, as social and economic restrictions to limit transmission take their toll.

One doctor administering vaccinations in Berlin said recipients were now asking far fewer questions about the vaccine than two weeks ago.

(Additional reporting by Stephanie Nebehay in Geneva, Crispian Balmer in Rome, Paul Carrel in Berlin, Tsvetelia Tsolova in Sofia, Matthias Blamont in Paris; Writing by Kevin Liffey; Editing by Mark Heinrich)