BERLIN/COPENHAGEN (Reuters) - Germany was weighing on Monday whether to allow a delay in administering a second dose of the COVID-19 vaccine from BioNTech and Pfizer to make scarce supplies go further, after a similar move by Britain last week.
Separately, Denmark approved on Monday a delay of up to six weeks between the first and second shots of the vaccine.
In Berlin, the health ministry was seeking the view of an independent vaccination commission on whether to delay a second shot beyond a current 42-day maximum limit, according to a one-page document seen by Reuters on Monday.
The move came amid criticism of Health Minister Jens Spahn - including from his conservative political allies - that Germany has failed to procure enough vaccines and been too slow to ramp up its national inoculation campaign.
Spahn told his Christian Democratic Union at a closed-door meeting on Monday that he hoped to offer vaccinations by this summer to everyone in Germany, once more vaccines have won regulatory approval, according to sources who attended.
Some German health experts have welcomed Britain’s move to delay administering a second dose of the BioNTech/Pfizer shot, which comes as governments try to provide protection against coronavirus to as many people as possible by giving them one shot and delaying a second.
“In view of the current scarcity of vaccines and the very high numbers of infections and hospitalisations (in Germany), a strategy in which as many people as possible are vaccinated as early as possible is more effective,” said Leif-Erik Sander, head of the vaccine research team at Berlin’s Charité hospital.
However, BioNTech and Pfizer pointed in a joint statement to a lack of trial data to support delaying the second dose
“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, referring to a prime shot and a booster given three weeks apart.
“There is no data to demonstrate that protection after the first dose is sustained after 21 days.”
The European Medicines Agency said a maximum interval of 42 days between the first and the second shot of the Pfizer-BioNtech vaccine should be respected to obtain full protection.
Evidence of the vaccine efficacy is based on a study where administration of doses was done 19 to 42 days apart, the agency said, noting that full protection comes only seven days after the booster.
It added: “Any change to this would require a variation to the marketing authorisation as well as more clinical data to support such a change, otherwise it would be considered as ‘off label use’.”
According to the latest daily update from the Robert Koch Institute, Germany has vaccinated around 239,000 people since starting its campaign on Dec. 27 - well short of the 1.3 million doses that were delivered by the end of 2020.
By way of comparison, Britain has administered more than a million COVID-19 vaccines so far, more than the rest of Europe put together, Health Minister Matt Hancock said.
The Danish Health Authority will allow a wait of up to six weeks before administering a second dose, its head Soren Brostrom told local news wire Ritzau on Monday, after scrutinising vaccine data.
But Brostrom said the original guidelines of waiting only three to four weeks should be followed whenever possible.
“If you go longer than six weeks, we cannot see the scientific evidence that you are protected with certainty. Therefore we cannot recommend that,” Brostrom added.
As of Monday, a total of 46,975 Danes had received the first Pfizer-BioNTech shot, mostly health workers and the elderly.
While a longer interval between shots has not been tested in clinical trials, some scientists said it was a sensible plan given the extraordinary circumstances.
European Union approval for a vaccine from Moderna, expected this week, should add another 1.5 million doses of supply in the coming weeks, the German Health Ministry document said.
In total, Germany, which has around 83 million people, should get 50 million doses of the Moderna shot this year under EU-wide procurement contracts.
Regarding the AstraZeneca vaccine approved last week by Britain, the German Health Ministry said the European Medicines Agency’s rolling review was proceeding at “high pressure”.
“The goal is, as soon as possible, to decide on the way forward and on the scope of approval” for the AstraZeneca vaccine, the document said.
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