Johnson & Johnson jab halted in US over clotting

Use of one-shot vaccine for under-30s in the UK under threat as health agencies investigate safety concerns

THE use of the one-shot Johnson & Johnson vaccine for under-30s is in jeopardy after the US and other countries suspended their rollouts because of blood clotting concerns.

The deputy chairman of the UK’S Joint Committee on Vaccination and Immunisation (JCVI) last night said there were “implications” for younger age groups, and that the group would have to review the latest safety data “very carefully”.

It followed reports of six dangerous blood clots in women in the US.

Any similar suspension in the UK could potentially hamper the smooth execution of Phase 2 of the rollout, which started yesterday.

The Government has ordered 30million doses of “jab and go” J&J vaccine, also known as the Janssen vaccine, which had reportedly been due to achieve regulatory approval as early as this week.

It is thought that planners had been lining up the jab – which could be available by around July –particularly for those aged 18 to 29 after the JCVI last week recommended they avoid the Oxford-astrazeneca vaccine due to a possible link to cerebral clotting.

They were told to seek an alternative jab because the risk from Covid in that age group does not outweigh the potential harm from clots.

However, some experts now fear the J&J jab, which uses the same adenoviral vector platform technology, is also causing the condition. Some 6.8million doses of the single-shot jab have been administered in America, but the US Food and Drug Administration (FDA) said yesterday that the vaccine’s rollout there would be temporarily paused out of an “abundance of caution”.

Cases of the very rare blood clots with low platelet counts were identified in women aged 18 to 48, of whom one has died and another is in a critical condition. As the US news broke, J&J announced it would “proactively delay” the jab’s rollout across Europe, where the first deliveries of the vaccine arrived only this week.

Joe Biden last night sought to calm nerves about the pause. “I made sure we have 600 million doses of the MRNA – not of either Johnson & Johnson and or Astrazeneca. So, there is enough vaccine that is basically 100 per cent unquestionable for every single solitary American,” he told reporters from the Oval office.

The European Medicines Agency is already investigating a possible link to clotting.

Professor Anthony Harnden, JCVI deputy chair, said the side effects reported in those receiving the Janssen vaccine in the US would need to be “carefully reviewed”, adding that there may be implications for recommendation of the vaccine in younger age groups in the UK.

Professor Jeremy Brown, another JCVI member, said it was too soon to tell whether the issue would hamper the UK’S wider vaccine rollout.

Dr Peter Marks, director of the FDA’S centre for biologics evaluation and research, said he would “hesitate to call it a class effect” – an effect common to all adenovirus vaccines. But he added: “It’s obvious to us already that what we’re seeing with the [J&J] vaccines looks very similar to what is being seen with the Astrazeneca vaccine.”

However, Dr Peter English, a past chairman of the British Medical Association’s public health medicine committee, described the move as “highly precautionary”.

“Even if all of the cases were caused by the vaccine, the risk of less than one in a million would have to be set against the benefits of protection from Covid-19 disease –a disease which, in itself, causes clotting in many cases,” he said.

Belgium said it would not stop its rollout of the J&J vaccine at this stage, while the Dutch drug regulator said the benefits of the vaccine outweighed possible risks. South Africa also has decided to suspend the rollout of the jab, though the health minister said teh country had not had reports of blood clots.

A spokesman for No 10 said: “On Johnson & Johnson, it’s for the MHRA to make a ruling. Obviously they are independent so I’m not going to prejudge their decision. It’s right that the independent safety watchdog looks at this and gives a ruling.”