Coronavirus: Authorities waiting for guidance from EMA over AZ vaccines

Authorities are awaiting guidance from the European Medicines Agency (EMA) regarding a possible link between AstraZeneca’s coronavirus vaccine and very rare cases of blood clots but do not anticipate the vaccine will be withdrawn, acting head of the pharmaceutical services Elena Panayiotopoulou told the Cyprus News Agency on Tuesday.

According to EU Health Commissioner Stella Kyriakides, an announcement is expected late on Wednesday.

“In close contact with EMA news on the pharmacovigilance assessment of the AstraZeneca vaccine. Evaluation expected late Wednesday,” Kyriakides wrote on Twitter.

The EMA and the World Health Organisation have both said the benefits outweigh the risks but are monitoring the situation. Panayiotopoulou said EMA’s safety committee PRAC was meeting today on the issue.

There have been differing responses from EU member states, with some restricting it to people aged over 60 and others authorising it for the general population.

Cyprus paused AstraZeneca vaccines for a few days in March but resumed them on March 19.

Marcos Cavaleri, chair of the EMA’s vaccine evaluation team told Italian daily Il Messaggero on Tuesday there was a link between the vaccine and very rare blood clots in the brain, but that the possible causes are unknown.

But this was denied by the EMA which, in a statement to Agence France-Presse, said the review is still ongoing and no conclusion has been reached.

And in a separate interview, Armando Genazzani, a member of EMA’s Committee for Medicinal Products for Human Use told La Stamp that it was “plausible” the blood clots were correlated to the vaccine.

The mixed messages have taken a toll on the take-up of the vaccine and fed into vaccine hesitancy countries keen to get their populations vaccinated so as to exit the lockdown can ill afford.

Other factors cited for the cold welcome to the AstraZeneca vaccine is the 12-week gap between the first and second dose, which means a three-month time lapse prior to full coverage compared to three weeks for Pfizer and Moderna.

Asked what Cyprus would do should the EMA to decide to withdraw the specific vaccine, Panayiotopoulou said guidance would be given to those already vaccinated. And she expressed the conviction that the EU would not withdraw the vaccine, as the number of reported side effects worldwide were negligible.

But she did not rule out the EU introducing some precautions. To the observation that Germany has restricted AstraZeneca vaccinations to people aged over 60, Panayiotopoulou noted that “Germany produces Pfizer” adding that the Baier vaccine, that is also German, is up for licensing review next.

Asked about comments by some people that they will not take the second shot, and whether this posed a risk to their health, she said there was no risk but urged them to follow the schedule so that the vaccines can be fully effective.

“If someone decides not to have the second dose, it’s as if they have not been vaccinated. The second dose boosts immunity,” she said.

Cyprus will follow whatever guidance is given by the EMA. “The reason Cyprus follows EMA is because it feels safer. It’s a different thing to have the EMA behind us which supplies us with information, knowledge and data so that there is a common direction, rather than acting spasmodically and in isolation. For anything that may arise we can turn to the EMA for advice,” she said.

She referred to EMA’s March 31 press release that the benefits outweigh risks of side effects. This has not changed and if it had we would have been told immediately. “Therefore Cyprus is going ahead in line with the guidance given by the relevant committee of the EMA which we are members of.”

In the UK, there have been seven reported deaths from 18 million vaccinations, which may be linked to thrombosis. However, in the general population, thrombosis deaths are higher, she said.

Cyprus has reports of side effects, but these are not confined to the AstraZeneca vaccine. “In Cyprus there have also been reports for the Pfizer and Moderna vaccines whereas there are occasional reports from abroad about neurological side effects relating more to the Pfizer vaccine and for blood clothing relating to AstraZeneca,” she said.

The specific vaccines are not at a disadvantage as regards benefits compared to other vaccines that have been in circulation for so many years. “There aren’t such side effects as to lead to the conclusion that vaccinations with the specific preparation should stop.”

And she added: “There are no pharmaceuticals that do not have at least one side effect and even the most innocent preparation can cause something.”

Some pharmaceuticals are harmful and cause side effects in some people but benefit others.

“You have scales, and you weigh the benefits and the risks. Cyprus does this for all medicine. The monitoring is carried out as required by law. People must feel safe. For the time being, the advantages and benefits of vaccinations significantly outweigh the risks of side effects and people are urged to get vaccinated,” she concluded.