Enraged at AstraZeneca over shortfall, EU calls
for vaccine export controls
New control would require companies to seek approval
before shipping vaccines internationally.
UK Government Continues To Ramp Up The Vaccination
Programme Against Covid-19
BY JILLIAN
DEUTSCH, FLORIAN EDER AND DAVID M. HERSZENHORN
January 26,
2021 1:19 am
The EU on
Monday called for tight controls on coronavirus vaccine exports after top
officials all but accused U.K.-based AstraZeneca of cutting supplies intended
for EU countries in order to sell doses to other nations at higher prices.
The move
came after two contentious vaccine steering board meetings on Monday between EU
and national officials and representatives of the British-Swedish
pharmaceutical conglomerate, which informed Brussels on Friday that vaccine
production would fall far short of its contractual obligations to the EU.
Furious EU
officials said the company had failed to explain the situation.
"Discussions
with @AstraZeneca today resulted in dissatisfaction with the lack of clarity
and insufficient explanations," EU Health Commissioner Stella Kyriakides
tweeted after the second meeting attended shortly before 10 p.m. "EU
Member States are united: vaccine developers have societal and contractual
responsibilities they need to uphold."
She
announced that another meeting will take place Wednesday. Earlier in the day,
Kyriakides announced the plans for the next export controls, while making clear
the Commission's suspicions that AstraZeneca had shipped vaccine elsewhere.
"The European
Union wants to know exactly which doses have been produced by AstraZeneca and
where exactly so far and if or to whom they have been delivered,"
Kyriakides said, adding that the Commission's proposed export mechanism would
require any company to disclose in advance any intended international shipments
of vaccine doses manufactured in the EU.
A
Commission official said the proposal for a new export control would require
companies to seek approval before shipping vaccines internationally, except for
humanitarian reasons. The restriction would be similar to limitations the EU
imposed last spring on exports of personal protective equipment when supplies
were scarce.
AstraZeneca
did not issue any statement on Monday in response to the Commission's
criticism, nor did it respond to repeated requests for comment about the
production shortfall.
The Commission's
swift move to impose the new export oversight, and the willingness of officials
to go public with their anger at the company, highlighted how access to
vaccines has become the highest-voltage political issue for public leaders as
the pandemic continues to rage, with record numbers of infections and extended
or renewed lockdown measures in many countries.
In a
further sign of how urgent the issue has become, AstraZeneca's vaccine has yet
to be formally approved by the European Medicines Agency. That formal step is
expected later this week, but the arrival of the vaccine is so
highly-anticipated that some EU leaders had pushed during a European Council
tele-summit on Thursday for shipments to begin in expectation of approval.
One EU
diplomat said AstraZeneca gave two reasons for the production shortfall,
related to materials sourcing and manufacturing problems at a plant in Belgium,
but the diplomats said the company had failed to substantiate those claims with
evidence. That led to speculation among Commission officials and EU national
officials that AstraZeneca had shipped doses manufactured in Belgium to other
customers, only to realize that production was not moving fast enough to meet
contractual obligations to the EU, which had made a prepayment running into the
hundreds of millions of euros.
"Trust
has been severely shaken," a Commission official said, adding: "To
this day, it has not been fully explained what happened to the money and what
has the company done on its obligation to manufacture at risk."
Another
Commission official said that throughout Monday, the company repeated they’re
“doing their best” again and again without any further details to increase the
production. The official called their explanations "nonsense."
Showdown
over slowdown
Word of
AstraZeneca's inability to meet its contract terms was the second big setback
for the EU in terms of vaccine supplies in recent days.
Pfizer,
which manufactures a vaccine in partnership with the German company BioNTech,
announced on January 15 that it was temporarily reducing deliveries to the EU
until late January in order to make changes to its production site in Belgium
to increase manufacturing. Some EU leaders voiced anger over the slowdown even
as Pfizer insisted that deliveries were expected to ramp up again beginning the
week of February 15. Italy sent Pfizer the company a formal warning on Monday
as well.
The blow
from AstraZeneca, however, is both worse in its scale and its ramifications.
Many EU countries chose not to order their full pro-rata allocation of mRNA
vaccines from BioNTech/Pfizer and Moderna because they were too difficult to
use and costly, choosing instead to bet on the British vaccine, which is
cheaper and logistically easier to handle.
For most of
the global vaccine race, Oxford/AstraZeneca was viewed as the frontrunner,
being one of the first to start clinical trials, pledging to sell its vaccine
at cost, and promising EU capitals a far easier serum to use compared to mRNA
jabs.
But
AstraZeneca is now looking like an increasingly bad bet, and new questions have
been raised about the vaccine's efficacy in people over the age of 65.
Germany’s
health ministry has decided to hold off administering the AstraZeneca vaccine
to seniors until there is proof of its efficacy among the over-65s, according
to a person familiar with the ministry’s thinking. That means Germany will be
forced to rely more on the BioNTech/Pfizer vaccine, which is in short supply,
to protect its most vulnerable population.
Still, the
company pushed back in a statement Monday night, saying such accusations are
“completely incorrect” and pointing out its use in such populations had been
supported by U.K. authorities. A spokesperson cited Phase 2 data published in
The Lancet journal, showing that older adults generated “strong immune
responses,” although this data does not show how effective the vaccine is for
older people.
AstraZeneca
was awarded the EU's first and most anticipated vaccine contract in August, and
in exchange received a giant prepayment. It was also granted far greater
indemnification protections than its rivals, meaning governments would help pay
parts of the legal costs should problems arise with the vaccine.
Kyriakides
on Monday said the EU had yet to see dividends. "The European Union has
pre-financed the development of the vaccine and the production and wants to see
the return," she said in a brief appearance between the two meetings with
AstraZeneca.
The company
has said it will now deliver 60 percent fewer doses to the bloc during the
first quarter than initially projected, and there were initial reports of
varying production difficulties. One EU official said a bad batch of vaccines
had to be discarded and the company was struggling to source enough raw
materials for mass production.
But after
an initial meeting with company officials on Friday and another that lasted
most of Monday afternoon, Kyriakides, visibly furious, delivered a statement,
saying the company had failed to adequately explain why its supply would fall
short.
"The
European Union wants to know exactly which doses have been produced by
AstraZeneca and where exactly so far and if or to whom they have been
delivered," Kyriakides said, adding: "The answers of the company have
not been satisfactory so far."
Matthew
Karnitschnig, Jakob Hanke Vela and Carlo Martuscelli contributed reporting.
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