January 12, 2022 Updated: January 13, 2022
The exterior of the European Medicines Agency is seen in Amsterdam, Netherlands, on Dec. 18, 2020. (Reuters/Piroschka van de Wouw)
The
EU’s drug regulator has expressed doubts about whether a second booster dose of
the currently available COVID-19 vaccines would be a sustainable long-term
approach.
“There
is an emergency discussion around the possibility of giving a second booster
dose with the same vaccine currently in use. Data has not yet been
generated to support this approach,” Marco Cavaleri, the European
Medicines Agency’s (EMA) head of vaccines strategy, told a media briefing.
He
added later, “We would like to see this data before we can make any
recommendation, but at the same time we are rather concerned about a strategy
that [involves] repeated vaccinations within a short term.”
An
additional vaccine booster shot “could be considered as part of a contingency
plan,” but “repeated vaccinations within short intervals will not
represent a sustainable long term strategy,” according to Cavaleri.
Concerns Over Immune
Response
When
asked to expand on his statements, Cavaleri said that for a hypothetical
approach of giving vaccine booster shots frequently, such as every four months,
“we will end up potentially having problems with immune response and immune
response may end up not being as good as we would like it to be, so we should
be careful in not overloading the immune system with repeated immunization.”
He also
noted that continuous administration of boosters can also lead to fatigue in
the population.
“It
will be much better to start thinking about an administration of boosters that
is more spaced in time,” Cavaleri said.
The EMA
is in conversation with vaccine developers in case there’s a need to update the
current vaccines, according to Cavaleri. But he said any change “would have to
be coordinated globally.”
More
data on the effect of the Omicron coronavirus variant on vaccines and a better
understanding of the evolution of the current wave are needed to decide whether
an Omicron-specific vaccine was needed.
“While
a monovalent Omicron vaccine would represent an obvious candidate to be
investigated, other options such as a multivalent vaccine cannot be ruled out
as potential alternatives,” Cavaleri said.
A Strategy to ‘Anticipate
the Next Move’
“It is
important that there is a good discussion around the choice of the composition
of the vaccine to make sure that we have a strategy that is not just reactive
after the virus changes, but try to anticipate what could be the next move and
try to come up with an approach that will be suitable in order to prevent a
future variant that, in any case, will emerge,” Cavaleri said.
The EMA
has called for a meeting with global regulators on Jan. 12, which will include
officials from the U.S. Food and Drug Administration.
“Tomorrow
we will be looking at all the evidence that we have so far with the current
vaccine, so the extent by which they are still providing vaccine effectiveness
and whether indeed we should still think that giving a booster shot at this
point in time is the best strategy,” Cavaleri said.
He noted
that the World Health Organization “will play a critical role” in
decision-making.
Cavaleri
noted that the CCP (Chinese Communist
Party) virus, which causes COVID-19, “is still behaving as a pandemic virus,
and the Omicron emergency is currently showing that.”
“So we
should not forget we are still in a pandemic,” he said. “Nevertheless, with
increase of immunity in the population and with Omicron there will be a lot of
natural immunity taking place on top of vaccination, we will be vastly moving
toward a scenario that will be closer to endemicity.”
Separately,
he noted, “Ideally, if you want to move toward a scenario of endemicity, then
such boosters should be synchronized with the arrival of the cold seasons in
each of the hemispheres, similarly to what we’re doing with influenza
vaccines.”
Pfizer Looking
at Omicron-Targeted Vaccine
On Jan.
10, Pfizer Chief Executive Albert Bourla said a COVID-19 vaccine that
specifically targets the Omicron variant of the virus, as well as
already circulating variants, “will be ready in March,” noting that the company
is “already starting manufacturing some of these quantities at risk.”
Bourla
said Pfizer is ready to file for U.S. regulatory approval for the redesigned
COVID-19 vaccine, and that the company has built up ample manufacturing
capacity, such that it won’t be a problem to switch immediately. He also noted
that COVID-19 vaccines eventually could be an annual shot for most people,
and some high-risk groups might be eligible to receive the shots more often
than that.
On Jan.
11, Cavaleri said April or May would be the soonest the EMA could approve any
variant-targeted vaccine.
“In
terms of the switch of the manufacturing, this is a decision that is beyond
EMA, and it will be very important there is a global discussion around the best
option here in the interest of public health,” he said.
Reuters contributed to this report.
EU drug regulator expresses doubt on need for fourth booster dose
EU drug regulator says repeated booster shots not a sustainable long-term plan
Cavaleri pointed out that getting a booster every four months
could potentially result in diminishing someone’s immune response. “We should
be careful in not overloading the immune system with repeated immunization,” he
said.
EU drug regulator expresses doubt on need for fourth booster dose
“If we have a strategy in which we give boosters every four
months, we will end up potentially having problems with immune response,” the
EMA’s Cavaleri said.
“And secondly of course there is the risk of fatigue in the
population with continuous administration of boosters.”
Covid-19 pandemic: Frequent boosters can weaken immunity, says EU
EMA press briefing 11 January 2022
https://www.youtube.com/watch?v=c_bdtDczwK0
Frequent Boosters Spur Warning on Immune Response
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