Denmark will follow the UK in delaying administering second doses of the Pfizer/BioNTech Covid-19 jab beyond the recommended 21-day period, despite safety warnings from the manufacturer against altering the vaccine regimen.
On Monday, the director of the Danish National Board of Health, Søren Brostrøm, told the news agency Ritzau it had updated its guidance so Danes could be given their second shot of the two-part inoculation up to six weeks after the first dose.
However, Brostrøm added that second doses of the Pfizer vaccine should still be given three to four weeks after the first, where possible, in accordance with the time period used in clinical trials to calculate the vaccine’s 95 percent efficacy rating.
Meanwhile, on Monday, German health chiefs were attempting to secure independent advice about whether to delay the second shot of the Pfizer vaccine beyond the 42-day maximum limit set by the European Medicines Agency (EMA), according to Reuters.
It comes after the UK government said last week it would make some people wait up to 12 weeks for their Covid booster jabs. The news coincided with the country’s approval of the AstraZeneca vaccine – the second it has authorized for use after Pfizer’s.
German tech firm BioNTech and US drugmaker Pfizer released a statement on Monday warning there was no evidence to suggest their joint vaccine would protect against the virus if the second dose was given later than in clinical trials.
“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,” it read.
“There is no data to demonstrate that protection after the first dose is sustained after 21 days.”
The EMA also issued a statement on Monday saying its 42-day maximum limit for administering that second dose should be respected and “any change to this would require a variation to the marketing authorization as well as more clinical data to support such a change.”
The EU’s drug regulator is still conducting a rolling review of the British-developed AstraZeneca vaccine and is also expected to rule in the next couple of days on whether to approve the US-developed Moderna Covid-19 vaccine.
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