- Coronavirus: AstraZeneca admits huge vaccine shortfall for EU
- What's going wrong at AstraZeneca?
- Drug companies struggle to meet EU orders
- The EU could approve more vaccines
- Covid-19 roundup: Pfizer/BioNTech release real-world evidence of vaccine efficacy; EMA gives J&J shot thumbs up
- EMA recommends J&J vaccine for authorization in EU
- Norway joins growing chorus of EU nations halting AstraZeneca rollout in wake of blood clot reports
- Moderna begins testing modified vaccine boosters
- High-income nations block patent protection waiver championed by developing countries
- EMA starts rolling review of Eli Lilly’s antibody combo
- The EU-AstraZeneca vaccine fight, explained
- The EU was slower to sign a deal with AstraZeneca than the US and UK. That delay may be causing problems now
- The EU is using its power to try to get vaccines, at whatever cost. This is exactly the type of vaccine nationalism the world feared would happen
Coronavirus: AstraZeneca admits huge vaccine shortfall for EU
Pharmaceutical company AstraZeneca will deliver to the EU less than half the amount of COVID-19 vaccine doses that it pledged for the first quarter of 2021, company boss Pascal Soriot admitted to European lawmakers on Thursday.
The drugmaker has long said it will not be able to fulfill its target, but the confirmation remains a blow to the EU's vaccine rollout.
The bloc has fallen far behind the United States, Britain and Israel in vaccinating its public, blaming supply chain issues. About 8% of the adult population of the EU have been vaccinated, according to European Commission Chief Ursula von der Leyen.
AstraZeneca will now try and deliver 40 million doses of its COVID-19 vaccine by the end of March, down from an initial 90 million.
The pledge is in line with previous statements from the company.
On Wednesday, AstraZeneca said it would only be able to deliver half the COVID-19 vaccines it was contracted to supply the EU in the second quarter of 2021.
The EU has repeatedly urged the firm to deliver more.
AstraZeneca CEO Pascal Soriot came under fire for his company's performance
What's going wrong at AstraZeneca?
Lower-than-expected yields — the amount of vaccine that can be produced from base ingredients — at its factories hurt output in the first three months, Soriot told EU lawmakers.
They discussed the bloc's slow vaccine roll out as part of coronavirus talks held via videoconference on Thursday.
“We are working 24/7 to improve delivery and hopefully catch up to the expectations for Q2,” Soriot said.
The company plans on upping production by using factories outside the EU that had no production problems, including in the United States.
Soriot did not mention the 180 million target set for the second quarter.
Media reports have suggested that second-quarter deliveries would be slashed to 90 million doses.
Drug companies struggle to meet EU orders
In addition to AstraZeneca's CEO, the executives from Moderna Inc and CureVac NV also participated in the panel.
Moderna Chief Executive Officer Stephane Bancel said the company has experienced fluctuations as it increases production of its COVID-19 vaccination.
He said usually a company would stockpile product ahead of a launch, but it is shipping every dose it makes, leaving it without any spare inventory.
- From Sweden to Cyprus, Lithuania to Italy, the push to get people their first shots is now under way, 11 months after the first cases were reported in Europe. EU leaders have dubbed the launch of the drive “V-Day,” a moment of unity in a pandemic that has killed more than 1.7 million people worldwide.
- Edith Kwoizalla, aged 101, was one of the first Germans to be vaccinated. She took the first of two doses at a care home in the eastern state of Saxony-Anhalt on Saturday, a day before the official launch. German Health Minister Jens Spahn said he expected 1.3 million doses to be delivered by the end of the year, with double that number by the end of January.
- The vaccine, developed partly by a German firm, has been snapped up by governments around the world. BioNTech has “scientific confidence” that its coronavirus vaccine will also work on the new variant detected in the UK, company CEO Ugur Sahin told DW. The proteins on the mutated form of the virus were 99% the same as the prevailing virus, he said.
- Hungary began vaccinating health care workers on Saturday, a day ahead of the EU's planned start date. Hungary has recorded over 316,000 cases and more than 9,000 deaths since the start of the pandemic.
- A Warsaw paramedic was one of the first people to receive the vaccine in Poland on Sunday. The first batch of 10,000 doses was transported from Pfizer's facility in Belgium to a warehouse in central Poland a day earlier. Prime Minister Mateusz Morawiecki called the launch “a great step in fighting the epidemic.”
- EU leaders and scientists have gone to great lengths to insist the vaccine is safe. In the Czech Republic, Prime Minister Andrej Babis (seen here) was at the head of the line for his vaccination on Sunday. In Vienna, three women and two men over the age of 80 got the vaccine in the presence of Austrian Chancellor Sebastian Kurz.
- Sweden, which has received praise and criticism for its looser handling of the pandemic, is expecting an initial batch of 10,000 shots, along with Norway. Denmark expects to have enough shots to initially vaccinate 40,000 people in care homes, followed by health care staff and those people with a high risk of illness. Iceland will receive 10,000 doses early in January.
- An 84-year-old man became the first patient to receive the coronavirus vaccine in Cyprus. While Europe has some of the best-resourced health care systems in the world, the sheer scale of the effort means some countries are calling on retired medics to help. Other countries have loosened rules for who is allowed to give the injections.
- A health care worker at the Hospital Favoriten in Vienna was one of the first in line to receive the vaccine. Austria is rolling the vaccine out through a three-stage program, starting with health care workers and people over the age of 65. Austria has recorded over 350,000 cases and more than 5,800 deaths since the start of the pandemic.
- Mauricette, a 78-year-old French woman, was the first person to receive a dose of the Pfizer-BioNTech vaccine at the Rene-Muret hospital in Sevran, on the outskirts of Paris. France is aiming to vaccinate the first million people by the end of February. The country has been one of the hardest hit in Europe, with over 2.6 million recorded cases and nearly 63,000 deaths.
- Italy began distributing the first batch of 10,000 shots on Sunday at the Niguarda hospital in Milan (seen here). In Rome, a 29-year-old nurse was the first to receive the jab at Rome's Lazzaro Spallanzani National Institute for Infectious Diseases. Health workers were first in line, with those over 80 to follow.
- The first phase of Portugal's vaccine rollout aims to inoculate 10% of the population, with front-line workers and those over 50 with preexisting conditions taking priority. Here, a medical worker receives the vaccine at Santa Maria hospital in Lisbon.
- Spain is set to receive 350,000 doses from Pfizer-BioNTech per week, with a total of nearly 4.6 million to be delivered over the next three months. The government has said it aims to vaccinate between 15 million and 20 million people in the first half of 2021. Here, a 72-year-old receives the first injection at the Vallecas nursing home in Madrid.
The EU could approve more vaccines
The European Commission has secured around 2 billion vaccine shots from several companies. But so far only three have been authorized: those from Pfizer-BioNTech, Moderna and AstraZeneca.
Officials say the Johnson & Johnson vaccine could be approved next month.
kmm/aw (Reuters, AP)
Covid-19 roundup: Pfizer/BioNTech release real-world evidence of vaccine efficacy; EMA gives J&J shot thumbs up
With their Covid-19 vaccine having been authorized for roughly three months, Pfizer and BioNTech have released a look into some real-world evidence regarding the shot’s effectiveness in Israel.
According to their analysis, the vaccine was at least 97% in preventing symptomatic disease, hospitalizations and death, as well as 94% against asymptomatic infections, Pfizer said in a release Thursday morning. The pair looked at data collected between Jan. 17 and March 6, when their shot was the only vaccine authorized in the country and the coronavirus variant that first emerged in the UK was the dominant strain.
“The findings which suggest that the vaccine may also provide protection against asymptomatic SARS-CoV-2 infections are particularly meaningful,” Pfizer Vaccines CMO Luis Jodar said in a statement.
In the seven-week analysis period, the UK strain made up 80% of tested specimens. Israel’s ministry of health was not able to determine effectiveness against the South Africa variant, however, as it made up only a limited number of cases during the same timeframe.
Additionally, the companies noted that vaccine effectiveness was measured two weeks after individuals received their second doses. Full results will be published in a scientific journal at a later date.
While Pfizer and BioNTech noted that the data align with their Phase III trial, which determined a 95% efficacy rate, they cautioned that the observational data collected in this study differ from those collected in a clinical setting. There remains a possibility of “unmeasured distortions,” they said, noting that the Israeli health ministry has indicated “neighborhood” may be a factor in the results.
Thursday’s study comes a couple of weeks after Israel’s Clalit Research Institute released peer-reviewed, real-world data suggesting the Pfizer/BioNTech vaccine cut symptomatic Covid-19 cases by 94% across all age groups and severe cases by almost as much. — Max Gelman
EMA recommends J&J vaccine for authorization in EU
Just a couple weeks after being authorized in the US, the J&J vaccine is getting prepped for an OK in Europe.
The EMA has formally recommended that the one-shot vaccine be authorized in the European Union, the agency said Thursday. The decision now heads to the European Commission, which has final say on all EMA-recommended therapies, where it will ly obtain the green light.
J&J’s vaccine would become the fourth Covid-19 jab authorized on the continent, joining the Pfizer/BioNTech, AstraZeneca/Oxford and Moderna vaccines.
European regulators cited J&J’s Phase III study as the basis for its recommendation, noting that the vaccine’s efficacy across the US, South Africa and Latin American hit 67% in symptomatic case reduction. The J&J shot was also the first of the US-authorized vaccines to demonstrate trial-backed efficacy against the coronavirus variant that first emerged in South Africa, hitting 55% against the strain.
Before and after gaining authorization in the US, J&J has been getting things moving on the production side, an easier feat than its mRNA rivals due to the vaccine technology’s similarity to seasonal flu shots and easier storage requirements. In late January, J&J said it expected to have 100 million doses for the US in the first half of 2021.
But last week in an unusual collaboration, J&J teamed up with Merck to vastly boost its vaccine production. Notably, Merck came up short in the Covid-19 vaccine race, dropping development of two vaccines in late January after Phase I data did not impress. — Max Gelman
Norway joins growing chorus of EU nations halting AstraZeneca rollout in wake of blood clot reports
On the heels of some European Union members refusing to allow the AstraZeneca/Oxford University vaccine to leave their shores last week, others are now halting distribution of the shot due to reports of blood clots.
Denmark and Austria temporarily suspended roll the vaccine on Wednesday after an individual was diagnosed with blood clots and died 10 days after receiving the shot, while another is recovering in the hospital from a pulmonary embolism. And early Thursday, Norway joined the growing list of countries pausing their AstraZeneca vaccine rollout programs, Reuters reported.
The EMA is currently reviewing the cases, and said in a statement that there’s currently no indication that the vaccines caused the events.
“The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population,” the EMA’s safety committee PRAC said in a statement Wednesday.
Blood clots are not listed as a side effect for the vaccine, PRAC added.
Danish and Austrian authorities have said they are taking these steps an abundance of caution. The vaccine’s use in Denmark will be paused for 14 days.
The issue, the EMA says, potentially deals with a specific batch of AstraZeneca vaccine that was shipped to 17 EU countries and contained 1 million shots. In addition to Austria and Denmark, four other nations have curtailed administration as of Tuesday: Estonia, Lithuania, Luxembourg and Latvia.
Though the EMA has said a quality defect is “unly,” the batch is being investigated.
News of the suspensions comes as AstraZeneca has run into hiccups across the continent trying to distribute its vaccine, created in conjunction with Oxford University.
Last week, Italy prevented a vaccine shipment destined for Australia from leaving its borders, marking the first instance of an EU nation taking advantage of new rules governing such shipments outside the bloc that were implemented in late January.
The drugmaker has also seen slow uptake around the world after fighting with the EU publicly over the doses promised in its contracts. And some people in European countries are reportedly shunning the vaccine in favor of mRNA-based shots with higher topline efficacy levels. — Max Gelman
Moderna begins testing modified vaccine boosters
In a major step toward battling variants of the coronavirus, Moderna has dosed the first volunteers with modified booster vaccine candidates.
Two different experimental vaccines are being tested: mRNA-1273.351 encodes for the spike protein of B.1.351, commonly called the South Africa variant of SARS-CoV-2; mRNA-1273.
211 is a multivalent shot combining that and the original, authorized vaccine against what Moderna calls ancestral strains.
The trial will enroll 60 participants who have already completed a two-dose mRNA-1273 regimen in previous studies, and each will receive one extra dose.
It’s all part of CEO Stéphane Bancel’s big plan to double down on the pandemic fight, scaling up production and keeping up with new research to stay in the lead created by the so far superior performance of their mRNA tech.
A year ago, Moderna didn't have an approved product. Today @CDCgov reports the company has supplied more Covid-19 vaccines to the U.S. than anyone else. pic.twitter.com/BSAe3OnAsS
— Jonathan Rockoff (@jonathanrockoff) March 10, 2021
Within the mRNA-1273.351 group, investigators will be giving 20 volunteers a lower, 20µg dose while another 20 will receive 50µg. For mRNA-1273.211, only 50µg will be tested.
These modified booster shots will be evaluated in parallel with a 50µg dose of mRNA-1273 offered to Phase II study participants. While lab studies suggest the original vaccine can kick up a strong antibody response against new variants, Moderna noted they are running the new studies “ an abundance of caution.”
The NIAID, with whom Moderna has been partnered from the start, is also planning a Phase I trial to access the two modified vaccines in people who have never been vaccinated.
As it enters a new era as a commercial biotech, Moderna says it’s also reinstalling Betsy Nabel on the board of directors.
Nabel, who until earlier this month was president of Brigham Health, resigned from the board after Brigham and Women’s Hospital was selected as a clinical site in the Phase III trial that ultimately showed Moderna’s vaccine 95% effective and cemented its emergency use around the world.
She’s since left her academic and hospital positions to join a biotech upstart launched by her husband, ex-Sanofi CSO Gary Nabel. — Amber Tong
High-income nations block patent protection waiver championed by developing countries
Low- and middle-income countries have been pushing the World Trade Organization to scrap patent protections for Covid-19 vaccines, claiming that removing the IP rights will speed up distribution in their countries. But on Wednesday, they ran into a stumbling block: the United States.
Wealthy nations the US, Britain and Switzerland, as well as several EU members, blocked a proposal by more than 80 developing countries that would waive patent rights for the shots, Reuters reported.
The move, first proposed by South Africa and India, would have suspended certain rules within the TRIPS agreement, which establishes a baseline for how WTO members can interact with each other’s intellectual property. Had it passed, it could have allowed generic drugmakers to start making vaccines and other therapies.
Richer nations have argued that stripping pharmaceutical companies of their intellectual property would hamper the innovation that helped lead to the vaccines and wouldn’t speed up manufacturing.
And last week, lobbying groups BIO and PhRMA both sent letters to the Biden administration urging the president to block the move. The PhRMA letter was co-signed by 30 prominent pharma executives, including Pfizer’s Albert Bourla, Eli Lilly’s David Ricks and Novartis’ Vas Narasimhan.
Wednesday’s move was the eighth time the South Africa-India proposal has been brought up for discussion since the proposal was first raised in October, Reuters said. There are plans to continue talking about some form before the next TRIPS council meeting in June.
Among those pushing for the removal of patent protections is the humanitarian group Doctors Without Borders, which published a statement Tuesday slamming wealthy nations for their opposition to the waiver.
“Countries must stop obstructing and show the leadership required to deliver on the ‘global solidarity’ they have so often declared during this pandemic,” international president Christos Christou wrote. “It’s time to champion access to medical tools for everyone, wherever they live.” — Max Gelman
EMA starts rolling review of Eli Lilly’s antibody combo
Just a day after Eli Lilly detailed positive data behind its Covid-19 antibody combo, the EMA says it’s started a rolling review for the bamlanivimab/etesevimab cocktail as well as bamlanivimab monotherapy.
Both uses have already been cleared by the FDA under emergency use authorizations.
The European regulators say they will start from animal data and continue until there’s enough evidence to support marketing authorization applications.
In the latest analysis, Eli Lilly reported that giving non-hospitalized patients 700 mg of AbCellera-developed bamlanivimab and 1400mg of Junshi-invented etesevimab reduced the risk of hospitalization of death by 87%, topping the 70% mark tracked earlier. Among 769 patients, researchers counted 4 events in the combo arm and 15 in the placebo group. — Amber Tong
For a look at all Endpoints News coronavirus stories, check out our special news channel.
The EU-AstraZeneca vaccine fight, explained
People line up to receive the AstraZeneca/Oxford Covid-19 vaccine outside a closed department store in Folkestone, UK, on January 27.
Chris Ratcliffe/Bloomberg/Getty Images
A spat between the European Union and the British-Swedish pharmaceutical company AstraZeneca is threatening to hamper global vaccine efforts, and is raising tensions on the continent as European countries struggle to vaccinate their populations amid the threat of new, more virulent strains of the coronavirus.
The EU purchased 400 million doses of the AstraZeneca vaccine, which the company made in partnership with Oxford University, in advance of it being approved by EU regulators.
But last week, AstraZeneca abruptly announced that due to production issues it would only be able to deliver about 31 million doses to the EU, or about 40 percent of the roughly 80 million doses promised in the first quarter.
That, of course, angered EU leaders, who are desperately trying to inoculate their populations.
Reuters reported Friday that the company agreed to throw in another 8 million more doses — but the EU says that’s not good enough and is demanding AstraZeneca do more, including using its plants in the United Kingdom to make up the shortfall.
AstraZeneca says it can’t do that, and that its contract with the EU (a heavily redacted version of which was published Friday) requires only that it make the “best effort” to deliver the vaccines to Europe. The problem is that the EU and AstraZeneca disagree on what “best effort” actually means.
And now the fight is threatening to spill over, with alarming implications for the global vaccination effort.
On Friday, the European Union approved the use of the AstraZeneca vaccine. But it also took the dramatic step of putting export controls on all coronavirus vaccines.
The final regulation is expected to be published Saturday, but it will require vaccine makers to notify the EU when exporting coronavirus vaccines to most countries outside the European Union; more than 90 countries are exempt, but not the United States or the United Kingdom. Individual EU member states will then have to authorize those exports, and can block them if they believe companies exporting the vaccines aren’t making good on their own delivery deals with the EU.
It’s not an outright ban on vaccine exports, and they are only expected to last until March, but experts and observers worry it sets a troubling precedent.
There are now several vaccines available,and more promising candidates on the way. But the EU-AstraZeneca feud is the latest sign that global cooperation and solidarity on vaccine allocation is failing, said Rebecca Weintraub, faculty director of the Global Health Delivery Project at Harvard University.
“This is vaccine nationalism 101,” she said.
The EU was slower to sign a deal with AstraZeneca than the US and UK. That delay may be causing problems now
The European Union, on behalf of its 27 member states, made deals with vaccine makers, betting on a bunch of potential candidates and buying up doses in advance. In total, the EU purchased 2.3 billion vaccine doses from a handful of companies.
But, initially, richer EU members Germany, France, Italy, and the Netherlands began to negotiate deals with vaccine makers themselves, including with AstraZeneca.
“That caused a lot of friction in Europe,” Christian Odendahl, chief economist at the Center for European Reform, told me.
“If you’re integrated both politically and economically, you don’t want to be vaccinated and your neighboring country to not be vaccinated.”
The bloc needed to ensure that smaller, less wealthy member states without big purchasing power would also be able to get vaccines. The solution? Have the European Union itself take over the vaccine buying process for all of the member states.
But that also turned the whole thing into “a very bureaucratically cumbersome process,” said Paulette Kurzer, an expert on European politics and public health at the University of Arizona. The EU had to consult with the individual governments and balance all their interests. Other issues, liability protection and the cost of vaccines, also slowed discussions.
The European Union did finally strike those deals, with AstraZeneca and other vaccine makers, but it was later in signing a contract with AstraZeneca than were others, including the United Kingdom.
Fast-forward to December, when the United Kingdom became the first country in the world to authorize a vaccine (the Pfizer-BioNTech one) for emergency use. The US soon followed, but EU approval didn’t come until toward the end of December.
Already a few weeks behind some of its counterparts, the European Union’s vaccine campaign has stayed sluggish compared to places Israel and the United Kingdom.
A shortage of doses has meant EU countries have had to scale back the pace of inoculation; Madrid, Spain, for example, is halting its vaccination program this week. Germany’s health minister has said shortages may persist through July.
New doses from AstraZeneca would ease some of this pressure. But then came the bad news, when AstraZeneca indicated it would fall short of its initial commitment.
AstraZeneca CEO Pascal Soriot, in an interview with the Italian newspaper La Repubblica, said that the company was working “24/7” to fix the “glitches” in its European production.
“But the UK contract was signed three months before the European vaccine deal,” Soriot said. “So with the UK we have had an extra three months to fix all the glitches we experienced. As for Europe, we are three months behind in fixing those glitches.”
The EU, though, has insisted that under the terms of the contract, AstraZeneca must use its manufacturing facilities in Britain to supply the EU with its share of doses. But AstraZeneca says it must first fulfill its obligations to the United Kingdom before it can supply Europe or anywhere else. Right now, it’s delivering about 2 million doses per week to the UK.
On Friday, AstraZeneca released its purchase agreement with the EU to try to help clear up the confusion. But that didn’t do much to resolve the dispute.
European Commissioner Ursula von der Leyen said Friday it’s “crystal clear” that the contract says AstraZeneca has to use British factories to supply the EU since its EU production is stalled.
AstraZeneca, again, is saying that according to the contract, it has to make its “best reasonable effort” to fulfill the dosage orders, and it says that is what it is doing.
So the stalemate between the EU and AstraZeneca remains.
In some ways, the details of the contract are beside the point. The European Union — which is facing a lot of pressure from its member states — is desperate to deliver these vaccines to its citizens. And, as expected, the global demand for a vaccine is vastly outstripping the supply and the pace at which companies can produce them.
The European public is frustrated with the vaccine rollout. They see other countries getting vaccinated faster. Individual member states are in charge of vaccination rollout and distribution within their own borders, so blaming the EU for botching the procurement process is a good way to deflect some of the blame coming from their citizens.
And AstraZeneca — with additional factories located so tantalizingly close in former EU member state the United Kingdom — is a useful target for the EU to transfer that blame one step further.
The EU is using its power to try to get vaccines, at whatever cost. This is exactly the type of vaccine nationalism the world feared would happen
The EU’s threat to block vaccine exports could directly hurt the UK, which relies on a plant in Belgium for its Pfizer vaccine doses. But other countries, Canada, have raised concerns over whether their supplies could be affected, too.
The biggest fear is that this could be the first domino to fall, as other countries feel they need to act in their own interest, and maybe block exports, or withhold raw materials — whatever leverage they can use to try to muscle vaccine doses for their populations.
“Our supply chains are global,” Julie Swann, an expert in health systems and supply chains at North Carolina State University, told me. “While the manufacturing of a supply chain may be in one part of the world, the raw materials or consumables or assembly may be in a different location. This path is potentially dangerous to push as a main strategy.”
Experts said the world could see a reprise of the early days of the pandemic, when some 80 countries or customs territories banned or restricted the export of supplies.
“This could reignite the ‘beggar-thy-neighbor’ policies that characterized the early days of the pandemic with regard to personal protective equipment, ventilators and other medical supplies,” Thomas Bollyky, senior fellow for global health, economics, and development at the Council on Foreign Relations, said.
The EU may perceive this decision to be in its self-interest. But if other countries follow suit, it could backfire — on the EU, and the rest of the world. Because it will almost certainly prolong the pandemic.
“It’s making more and more clear, the huge chasm between what people are saying and what they’re doing,” Krishna Udayakumar, director of the Duke Global Health Innovation Center, told me.
The EU, in particular, he said, was seen as a leader in global health equity. It’s given a lot of support to Covax, the multilateral effort to help low-income countries get vaccinated.
And yet everyone is still looking out for themselves.
“At the end of the day,” he said, the EU is “doing whatever they can to get access to vaccines as quickly for their own population as possible.”
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