eu vaccine :: Article CreatorPfizer/BioNTech Initiate Application With EU Regulator For Updated COVID Vaccine
June 23 (Reuters) - Pfizer (PFE.N) and partner BioNTech (22UAy.DE) said on Friday they have initiated an application to the European Medicines Agency (EMA) for authorization of updated COVID-19 vaccine targeting Omicron subvariant XBB.1.5.
Earlier in June, Europe's medicine regulators backed the World Health Organization's recommendation to update the antigen composition of COVID shots to target one of the currently dominant XBB variants ahead of the upcoming autumn vaccination campaign.
Pfizer/BioNTech said they expect to be ready to ship XBB.1.5-adapted monovalent vaccines to member states of the European Union immediately following regulatory approval.
The companies added they also plan to file an application with the U.S. Drug regulator in the coming days.
Moderna (MRNA.O) said on Thursday it had completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine targeting XBB.1.5.
Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra Eluri
Our Standards: The Thomson Reuters Trust Principles.
EU And Pfizer Renegotiate Controversial Vaccine Contract
Press play to listen to this article
Voiced by artificial intelligence.
The European Commission and U.S. Pharmaceutical giant Pfizer have renegotiated a massive contract for COVID-19 vaccine doses that the EU entered into at the height of the pandemic.
The Commission announced that the two parties had agreed Pfizer would spread out deliveries over the course of the next four years, into 2027, and to reduce the total amount of doses down from the 450 million that were due to be delivered this year. However, the Commission didn't disclose the new total in its announcement. When asked by POLITICO about the revised delivery figure, Commission Health Spokesperson Stefan de Keersmaecker referred POLITICO to EU member countries for a response.
"Vaccine strategies or vaccine programs are designed and implemented by the member states," said de Keersmaecker.
The Commission had previously obtained a number of concessions from Pfizer, but these always stopped short of a reduction in doses.
The financial terms of the deal are also not public, but the Commission said that the bloc retained the possibility to buy the remainder of the original 450 million doses, and that it was paying extra for the option — something that ministers have previously criticized as a "cancellation fee." In practice, this increases the price per dose, though the overall price tag would be lower.
The talks have dragged for over a year and have been marked by acrimony — at least from the part of a group of Central and Eastern European countries that have bitterly opposed the terms of the contract that they'd entered into.
The contract in question was signed in May 2021 and was originally for 900 million doses doses of the vaccine that was jointly developed with Germany's BioNTech, with the possibility to exercise an option for another 900 million doses. Eventually, a total of 1.1 billion shots of the mRNA vaccine were contracted by the bloc — worth €21.5 billion according to vaccine prices reported by the Financial Times.
450 million doses were due to be supplied in 2023, though deliveries were put on pause while the negotiations were ongoing. Already in April last year, Poland announced that it was not accepting any more deliveries of vaccines, complaining of an oversupply.
A total of nine other countries from the region joined Poland in lobbying for a renegotiation, complaining that they were stuck buying doses that they no longer needed, at a time of economic difficulty caused by the energy shock, and while having to spend money to take care of refugees from the Russian invasion of Ukraine. The group of countries wanting to renegotiate the contract also have lower vaccination rates than their Western European counterparts.
In an unusual move, Poland went as far as sending a letter to Pfizer's shareholders where it laid out its reasons for wanting a renegotiated deal, as it sought to heap pressure on the U.S. Drugmaker.
The dustup has also focused attention on Commission President Ursula von der Leyen's personal role in securing the original contractSean Gallup/Getty Images
The dustup has also focused attention on the Commission President Ursula von der Leyen's personal role in securing the original contract. According to the New York Times, the boss of the EU executive exceptionally negotiated with Pfizer's Chief Executive Albert Bourla directly, over text messages. But the content of the messages has been shrouded in secrecy, with the Commission refusing to even confirm their existence.
The long-standing negotiations raise the question of why such a large contract was entered into with deliveries so far in the future — in 2022 and 2023 — when the pandemic conditions might have changed, without a clause to negotiate down doses.
CDC Tracking New COVID Variant EU.1.1
The Centers for Disease Control and Prevention is now separately tracking several new COVID-19 variants, the agency announced Friday, adding more Omicron descendants to an increasingly complex list of new strains that are competing nationwide.
Among the new variants now being tracked by the CDC is EU.1.1, a strain first designated by scientists earlier this year over its rapid ascent in some European countries.
The variant is a more distant descendant of the XBB.1.5 variant that had surged earlier this year, with a handful of more mutations to its spike protein that may be driving its spread.
The CDC estimates that EU.1.1 is now 1.7% of U.S. Cases nationwide, but may have already reached as much as 8.7% of cases in the region spanning Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming.
It is too early to know whether EU.1.1 will lead to new or different symptoms in the U.S.
Despite some anecdotal reports, health officials have said there's little evidence of previous variants leading to changes in COVID-19's effects. Changes over time in the underlying immunity of those infected can have an impact on how people are affected by the virus, further muddying reports of shifts in symptoms.
Virtually all Americans are now estimated to have antibodies from a vaccination, at least one infection or some combination of the two. A growing share of hospitalizations and deaths are now from reinfections, the CDC reported Thursday.
Many EU.1.1 cases in Utah
Laboratories in Utah have sequenced the most EU.1.1 infections of any state, with nearly 100 cases of EU.1.1 reported by the state's public health laboratory to global virus databases.
By contrast, labs in neighboring Nevada and Colorado have reported only single-digit numbers of EU.1.1 sequenced infections.
However, Utah's overall COVID-19 trends currently look similar to the rest of the country, which is currently around record low levels seen during previous spring and summer months.
A consortium of academic and federal modelers recently projected that the U.S. Would likely continue to see lulls in COVID-19 hospitalizations and deaths during the warmer months of at least the next two years, with subsequent peaks during the fall and winter unlikely to surpass previous records.
The pace of new COVID-19 hospital admissions and emergency room visits in Utah have largely slowed or plateaued over the past few months, according to CDC figures. Reported nursing home cases there also remain far lower than past winter peaks.
XBB.1.5 declines nationwide
Most variants nationwide are still grouped by the CDC into one of four strains within the XBB family of SARS-CoV-2 variants.
The largest is XBB.1.5, which has fallen to a projected 27.0% of infections. Another is XBB.1.9.2 and XBB.1.9.1, which together make up 24.4% of cases. XBB.1.16 is the next largest, at 19.9% of circulating viruses. Below them is XBB.2.3, at 10.6% nationwide.
The Food and Drug Administration decided earlier this month that COVID-19 vaccines this fall should be revised to target the XBB.1.5 variant. But officials say all these strains, as well as a myriad of their direct descendants, appear to be so closely related that the new shots will broaden immunity for all of them.
Moderna announced Thursday it had already formally completed its submission for emergency use authorization of its newly revised shots for the fall.
While officially designed to target XBB.1.5, the drugmaker touted research suggesting its new vaccine would offer "robust human immune responses" effective at protecting against its relatives XBB.1.16 and XBB.2.3 as well.
Coronavirus Pandemic More
CDC tracking new COVID variant EU.1.1
West Virginia governor defends "Do it for Babydog" vaccine lottery
West Virginia's COVID vaccine lottery under scrutiny
DeSantis wasn't always a COVID rebel
COVID hospitalizations reach new record low nationwide, CDC says
MoreAlexander Tin
CBS News reporter covering public health and the pandemic.
Comments
Post a Comment