Janssen COVID jab cleared in UK as fears of third wave mount

With concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use of a fourth vaccine from Johnson & Johnson's Janssen division.

The Medicines and Healthcare products Regulatory Agency (MHRA) gave a green light to the single-dose Ad26.COV2.S vaccine in people aged 18 and over by referencing the decision of the European Medicines Agency (EMA), which backed emergency use of the vaccine in March.

That temporary regulatory route that will only be valid for two years from the UK's departure from the EU on 1 January.

In the phase 3 ENSEMBLE trial reported in January, Janssen's one-shot vaccine was shown to be 67% effective overall in preventing COVID-19 infection and 85% effective in preventing severe disease or hospitalisation.

The UK government has agreed an order for 20 million doses of the vaccine which are due to be delivered later this year, although that is a reduction on the 30 million originally ordered given the "unprecedented scale and pace" of the national vaccination programme, said the MHRA.

At current vaccination rates the UK expects all adults to have been offered at least one dose by the end of next month.

Health Secretary Matt Hancock said the Janssen vaccine "will play an important role in the months to come as we redouble our efforts to encourage everyone to get their jabs and potentially begin a booster programme later this year."

A two-dose vaccine from Janssen is also being trialled in the UK at 16 National Institute for Health Research (NIHR) sites across the country. The phase 3 trial involves more than 6,000 volunteers in the UK, some of whom were recruited from the NHS Vaccines Registry.

Like the AstraZeneca/Oxford University shot that has formed the backbone of the UK vaccination drive, Ad26.COV2.S is based on an adenovirus and has been linked to rare blood clots that have resulted in age-based restrictions on its use in some countries, including most recently in Belgium.

Also approved in the UK are two vaccines from Pfizer/BioNTech and Moderna, which are both based on mRNA.

The approval comes as there are signs that the UK is already approaching a third wave following the relaxation of lockdown rules last month, and ahead of further easing due on 21 June.

Yesterday the UK reported more than 3,000 new coronavirus infections for the sixth consecutive day, with the majority of new cases linked to the B.1.617.2 variant first identified in India.

Prof Ravi Gupta from the University of Cambridge, who advises the government on the pandemic, told the BBC yesterday that while case numbers are still relatively small "what we are seeing here is the signs of an early wave."

He added that the vaccination programme means it will likely take longer for this wave to gather momentum compared to the first two, and warned against a complete lifting of social restrictions in three weeks' time.

EU expands Pfizer/BioNTech vaccine label

Meanwhile, the EMA has followed the US FDA in approving expanded use of the Pfizer/BioNTech coronavirus vaccine for use in 12 to 15 year olds, the first for this age group, in addition to its current use in people aged 16 and over.

The Committee for Medicinal Products for Human Use CHMP concluded that the benefits of the vaccine in this age group outweigh its risks.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently investigating cases of heart inflammation with the vaccine, mainly in people under 30 years of age.