By Francesco Guarascio and Ludwig Burger
BRUSSELS, March 3 (Reuters) - The European Union drug
regulator does not see enough evidence yet to recommend changes
to the dosage regime for COVID-19 vaccines, despite pressure
from EU states after positive data on the level of protection of
a single shot.
EU nations' vaccination plans are lagging behind the United
States and former EU member Britain, a delay that has prompted
some countries to push for new approaches, including on the
administration of vaccines.
Britain has been faster partly because it has extended the
interval between vaccine doses. For the Pfizer-BioNTech
vaccine, London recommends the booster should be
given after 12 weeks, whereas the guidance from the European
Medicines Agency (EMA) follows the companies' recommendations of
a second dose after three weeks.
The EU regulator recommends the second shot of AstraZeneca's
vaccine is administered between four and 12 weeks after
the first, the same as the UK watchdog.
Asked whether tweaks were being considered, the EU regulator
said late on Tuesday: "If and when new evidence for changes to
dosing schedules becomes available, this will be assessed by
EMA's scientific committees."
An EU official told Reuters that dosing changes were not
expected at the moment as more evidence was needed.
Deviating from approved dosing schedules before getting
sufficient evidence "might result in a risk of loss of
effectiveness" of the vaccines, EMA said in its emailed
statement on Tuesday.
EMA's comments came after a meeting of EU health ministers
on Monday in which government representatives discussed the
feasibility of more flexible dosages, based on emerging data,
according to an EU official who attended the meeting.
Hungary said on Monday it would try to stretch vaccine
supplies by extending the period between the two shots to rein
in fast-spreading infections.
Italy's new Prime Minister Mario Draghi also suggested at a
meeting of EU leaders last week that the first jab should be
given priority.
Despite the pressure, EMA on Tuesday also said that vaccine
makers had provided no evidence that would support the use of
one single shot.
At present the EU has authorised the use of COVID-19
vaccines from Pfizer-BioNTech, Moderna and AstraZeneca
, based on strong data when administered in two doses.
The pivotal trials were not designed to provide insight into
the merits of just one shot but researchers have analysed
real-world data after launch.
Initial results of a UK study among healthcare staff found
in February that a single dose of the Pfizer-BioNtech vaccine
cuts the number of asymptomatic infections by about 75%, which
would significantly reduce the risk of transmission of the
virus.
A separate study in Israel last week showed a single shot of
the Pfizer vaccine was 57% effective in protecting against
symptomatic infections after two weeks.
(Reporting by Francesco Guarascio in Brussels @fraguarascio and
Ludwig Burger in Frankfurt;Editing by Elaine Hardcastle)
Astrazeneca (AZN)
