London: The pharmaceutical giants behind a key coronavirus vaccine says there is “no data” to support Britain’s decision to alter the dosing schedule so that more people can get the jab sooner.

The government last week announced its new focus was to give the BioNTech-Pfizer vaccine to as many people as possible, meaning the window between receiving the first and second shot would increase from three weeks to three months.


Health officials have said the shift would make a better use of scarce supplies and stressed the first shot will still provide strong protection from the worst effects of COVID-19.

The delay will also apply to the newly approved Oxford-AstraZeneca vaccine, which was injected into the first patient in Britain on Monday.

Many experts have supported the decision to delay the second jab so that more people can get the first given the gravity of the UK’s rapidly worsening second wave. But others such as US infectious diseases chief Anthony Fauci have criticised the dosing regime because it was not tested in clinical trials.

In a joint statement released on Monday, Germany drug company BioNTech and its American partner Pfizer said there was “no data” to demonstrate that the protection offered by the first dose would be sustained after three weeks.

Brian Pinker, 82, receives the Oxford-AstraZeneca COVID-19 vaccine from nurse Sam Foster at the Churchill Hospital in Oxford.Credit:Getty

“The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” the companies said in a joint statement.

Britain’s plan to extend time between doses comes as England is about to return to its toughest lockdown since the first imposed late last March. People will only be legally allowed to leave their homes to shop for essentials, get medical treatment, escape domestic abuse or go to work when absolutely necessary, and schools will also close.

Hospitals in England are already overstretched and infection numbers are not dropping under current restrictions. The UK announced 59,000 new cases on Monday – the seventh day in a row it has recorded more than 50,000 cases.

The statement did not explicitly criticise the government’s new approach but it has renewed scrutiny on Downing Street’s plan.

Australia has a deal to secure 10 million doses of the Pfizer vaccine and 53.8 million doses of the AstraZeneca product.

The Australian dosing regime will be determined as part of the current approval process.

Germany’s health minister has asked the country’s diseases agency to consider whether Berlin should also follow the UK approach.

But in a warning shot, the European Medicines Agency said on Monday that a maximum 42 days between the first and the second dose of the Pfizer-BioNtech vaccine should be respected to obtain full protection.

Evidence of the vaccine efficacy is based on a study where the doses were administered 19 to 42 days apart, the agency noted.

In a letter to health professionals in the UK issued on New Year’s Eve, the chief medical officers for England, Scotland, Wales and Northern Ireland said the scientific and public health rationale for a delayed booster shot was sound.

“As with all decisions during this pandemic it is about balance of risks and benefits,” they said.

“We are confident that based on publicly available data…that the first dose of either Pfizer or AstraZeneca vaccine provides substantial protection within two to three weeks of vaccination for clinical disease and in particular severe COVID disease.

“The second vaccine dose is likely to be very important for duration of protection, and at an appropriate dose interval may further increase vaccine efficacy. In the short term, the additional increase of vaccine efficacy from the second dose is likely to be modest; the great majority of the initial protection from clinical disease is after the first dose of vaccine.”

“In terms of protecting priority groups, a model where we can vaccinate twice the number of people in the next two to three months is obviously much more preferable in public health terms than one where we vaccinate half the number but with only slightly greater protection.”

Health officials have also said there is some evidence to suggest extending the time between the first and second dose of the AstraZeneca vaccine might actually produce an even stronger level of protection.

“We certainly saw better immune responses with a longer gap,” Professor Andrew Pollard, the director of the Oxford Vaccine Group, said on Monday.

Professor Andrew Pollard, the director of the Oxford Vaccine Group, receives the jab given his status as a frontline health worker. Credit:Getty

“At the moment the numbers are a bit small to be absolutely sure that translates into better protection but we think it should. And so I think there’s no harm in having the longer gap, and there may be a benefit as well.”

Professor Pollard said trial data showed the Oxford-AstraZeneca vaccine offered about 70 per cent protection a couple of weeks after the first dose.

Brian Pinker, an 82-year-old dialysis patient, was the first person in Britain to be given the newly approved AstraZeneca jab on Monday.

More than 1 million Brits have received at least one dose of the Pfizer or AstraZeneca vaccines.

With Reuters

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