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UK switches vaccine strategy after thrombosis risks assessed

Thursday April 8th 2021

The UK is to offer under 30s alternatives to the Oxford adenoviral COVID-19 vaccine after confirming a small increased risk of serious thrombotic events, it was announced last night.

It came as regulators reported a significant increase in the number of reports of thrombotic events that have followed vaccination.

All the events were associated with low platelet counts, the Medicines and Healthcare products Regulatory Agency said.

It found 79 cases of thrombosis of low platelet counts including 19 deaths. These include 44 cases of cerebral venous sinus thrombosis and 35 cases of thrombosis in other major veins. The numbers represent four cases for every million doses.

The government advisers did not attempt to compare this risk with normal occurrence of these diseases – but stressed that vaccination continued hugely to reduce the risk of serious disease from COVID-19.

MHRA chief executive Dr June Raine said: “No effective medicine or vaccine is without risk. We continually monitor safety during widespread use of any vaccine. This is to ensure vaccines are performing as expected, to identify any new side effects that may arise, and to ensure the benefits continue to outweigh the risks.

“We thoroughly analyse each and every report as we receive it and although the number of reports of CVST and other thromboembolic events has increased over the last week, so has the overall number of vaccinations administered, therefore these blood clots remain extremely rare and unlikely to occur.

“We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.”

A statement from the Joint Committee on Vaccination and Immunisation added: “Given the very low numbers of events reported overall, there is currently a high level of uncertainty in estimates of the incidence of this extremely rare adverse event by age group. However, the available data do suggest there may be a trend for increasing incidence of this adverse event with decreasing age, with a slightly higher incidence reported in the younger adult age groups.”

The committee said it would be issuing further advice for under 30s – but advised that they should be offered alternative vaccines.

British Medical Association chair Dr Chaand Nagpaul said: “It is absolutely right that the JCVI is being honest about the change of direction in advising those who are under 30 to be vaccinated with either the Moderna or Pfizer vaccine - we are fortunate that there are alternative vaccinations that can be offered to those under thirty.

“England’s Deputy Chief Medical Officer said that giving those under 30 – who are at less risk - an alternative vaccine may mean these patients have to travel further to be given it or wait a little longer to be vaccinated; it’s important that NHS England does everything it can to make this process as easy as possible so that patients will get their first and second doses so that the public can continue to have confidence in the programme.”

A government statement added: “Everybody who has already had a first dose of the AstraZeneca vaccine should receive a second dose of the same brand, irrespective of age, except for the very small number of people who experienced blood clots with low platelet counts from their first vaccination.

“The Government will follow today’s updated advice, which sets out that, as a precaution, it is preferable for people under the age of 30 with no underlying health conditions to be offered an alternative vaccine where possible once they are eligible.

“When people are called forward, they should get their jab. Vaccines are the best way out of this pandemic and provide strong protection against COVID-19.”

[MHRA statement]

Tags: Flu & Viruses | Heart Health | Pharmaceuticals | UK News

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