BioNTech sounds warning about delaying second shot as Germany plans to follow UK’s lead on vaccines

EU is facing heavy criticism over its inoculation strategy

Powered by automated translation

Vaccine developer BioNTech has warned countries against allowing a delay in administering a second dose of its vaccine as Germany considers following the UK’s lead on the longer delivery schedule.

The move comes amid anger about the European Union’s inoculation strategy and concern the bloc’s stockpileis insufficient.

But BioNTech warned there was no evidence to support the change in administering the second dose of its vaccine, developed in partnership with Pfizer.

Germany has immunised about 240,000 people, while only a few hundred shots have been administered in France.

The EU suffered another blow on Monday night after the medicines regulator delayed a decision on whether to approve the Moderna vaccine.

Facing criticism over the country’s inoculation campaign, German Health Minister Jens Spahn asked disease control agency the Robert Koch Institute to consider postponing second doses of the Pfizer/BioNTech vaccine to make scarce supplies go further.

An RKI spokeswoman said on Tuesday morning the proposal was still being investigated.

On Monday, Denmark approved a delay of up to six weeks between the first and second shots. If a similar strategy is approved in Germany, it would mirror that of the UK.

British officials decided last week to allow a 12-week window between the two shots with the aim of boosting the number of people who would receive an initial layer of protection.

Recipients of the Pfizer/BioNTech dose were initially told to allow three weeks between receiving the jabs.

The UK has administered about one million doses of Covid vaccines, and Prime Minister Boris Johnson says he aims to inoculate 14 million people by mid-February. On Tuesday, ministers tied the relaxation of lockdown rules to the vaccination rate.

Some German health experts welcomed Britain’s approach.

“In view of the current scarcity of vaccines and the very high numbers of infections and hospital admissions 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 vaccine research at Charite hospital in Berlin.

BioNTech warned there was no evidence to support delaying the second shot of its vaccine beyond three weeks.

It said its clinical data showed 95 per cent efficacy was based on a two-dose schedule separated by 21 days.

“The safety and efficacy of the vaccine has not been evaluated on different dosing schedules,” the German company said.

“Although data ... demonstrated that there is a partial protection from the vaccine as early as 12 days after the first dose, there is no data to demonstrate that protection after the first dose is sustained after 21 days.”

A soldier escorts an elderly visitor as they exit a Covid-19 vaccination site at Berlin Arena in Berlin, Germany, on Monday, Jan. 4, 2021. Germany is poised to extend stricter lockdown measures beyond Jan. 10 amid criticism over alleged failures in the government’s fledgling vaccination program.  Photographer: Liesa Johannssen-Koppitz/Bloomberg
A soldier escorts an elderly visitor from a Covid-19 vaccination clinic in Berlin. Bloomberg

Meanwhile, German Chancellor Angela Merkel is expected to extend the country’s national lockdown.

Mrs Merkel and the premiers of Germany’s 16 states are due to talk on Tuesday, with regional leaders signalling that they would prolong the current partial lockdown beyond the January 10 deadline, probably until the end of the month.

On December 10, Germany’s daily death toll surpassed 1,000 for the first time.

“Given that infection rates are still too high, it will be necessary to extend the restrictions,” Mr Spahn said.

Michael Kretschmer, the premier of Saxony, said a continued shutdown was unavoidable. The eastern state has the highest infection rate of any region in the country.

In a New Year’s Eve televised address, Mrs Merkel warned Germans of a hard winter coping with the virus.

“The challenges that the pandemic poses remain immense,” she said.