The European Medicines Agency (EMA) has approved two factories for the production of COVID-19 vaccines, with the European Union banking on them to boost deliveries in the second quarter and accelerate the slow pace of inoculations in the bloc, write Philip Blenkinsop and Joan Faus.
The EMA said in statement it had cleared the Halix production site in the Netherlands that makes the AstraZeneca vaccine and a facility in Marburg in Germany producing BioNTech/Pfizer shots.
The European Union has blamed massive shortfalls of AstraZeneca doses for the slow roll-out of vaccines across the bloc, while BioNTech/Pfizer has plans to sharply increase its deliveries in the second quarter.
European Internal Markets Commissioner Thierry Breton said vaccines produced by AstraZeneca within the bloc would stay there until the company returns to fulfilling its delivery commitments.
His comments echoed those of Commission President Ursula von der Leyen after a video conference summit of EU leaders on Thursday. Of 300 million doses due to be delivered to EU countries by the end of June, AstraZeneca aims to deliver only 100 million.
AstraZeneca’s request to the EMA for authorisation of its Dutch plant run by subcontractor Halix was only confirmed on Wednesday by EU Health Commissioner Stella Kyriakides.
It is not clear why the request only came now despite Halix being listed as a supplier in the company’s contract with the European Union in August. AstraZeneca has declined to comment on the timing, but said Halix is a relatively small part of its vaccine supply chain. Halix says its monthly production is about 5 million doses.
Kyriakides said she expected vaccines from this plant to be delivered to EU countries in the coming days as part of AstraZeneca’s commitment to EU citizens.
It is also unclear whether the approval of Halix will allow the distribution of 16 million doses of AstraZeneca vaccines seized this week by the Italian authorities, and which AstraZeneca said were waiting approval before being shipped to EU countries. AstraZeneca declined to comment on this.
If the doses seized in Italy were manufactured at Halix, as European Union sources had suspected, the green light for the site would mean the batch is cleared for use.
Under an AstraZeneca internal schedule dated March 10 and seen by Reuters, the company expected to deliver to the EU nearly 10 million doses of vaccines next week, a third of its entire supply to the EU so far.
The supply forecast hinged on the approval of the Halix site, the document said.
MAJOR PFIZER-BIONTECH RAMP-UP
Italian Prime Minister Mario Draghi reiterated on Friday his threat to put export blocks on companies that failed to honour vaccine delivery commitments, and ruled out getting into trade disputes with countries such as Britain over supplies.
“I don’t want to go into details and without naming names, but one has the impression that some companies deliberately sold the doses two or three times,” he said with a laugh, and without elaborating.
Draghi said he expected at least 4 million more vaccine doses to get to Italy before the end of the month, with production slowly being ramped up in various sites.
Underscoring the growing output capacity, the EU’s drugs regulator also granted German biotech firm BioNTech approval for the use of COVID-19 vaccines produced at its new site in Marburg.
BioNTech launched production in February at the site, which it purchased from Novartis last year. The firm said on Friday the Marburg site had an annual capacity of 1 billion doses, up from 750 million doses flagged previously.
That makes it a key element of BioNTech and partner Pfizer’s global delivery plans of 2.3 billion to 2.4 billion doses this year.
The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April.
Kyriakides called the approval “very good news” that should enable the expected acceleration of production and deliveries.
Therapeutics Strategy - First rolling review of a new COVID-19 medicine
The European Medicines Agency has today (7 May) started the rolling review of sotrovimab (VIR-7831), a monoclonal antibody developed for the treatment of COVID-19. The review follows hot on the heels of the EU COVID-19 Therapeutics Strategy presented yesterday and is a first step towards the Strategy's target of starting seven rolling reviews of COVID-19 therapeutics in 2021. The rolling review launched by EMA will assess sotrovimab's effectiveness in preventing hospitalization and death; safety and quality. A rolling review is quicker than a regular evaluation as data is reviewed as it comes in. Should the European Medicines Agency recommend authorising the treatment at the end of its review, the European Commission will move swiftly to authorize it.
The EU Therapeutics Strategy supports the development and availability of much needed COVID-19 therapeutics and covers the lifecycle of medicines: from research, development and manufacturing to procurement and deployment. It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19. More details on the EU Therapeutics Strategy are available in a press release and factsheet.
Kazakhstan to deliver humanitarian assistance to India
Kazakhstan will provide humanitarian assistance to India due to the sharp deterioration of the epidemiological situation in this country, reported the Akorda Press, writes Zhanna Shayakhmetova.
This was announced at the meeting of Kazakh President Kassym-Jomart Tokayev and Prime Minister Askar Mamin on May 7.
President Tokayev instructed the government to dispatch 6 million medical masks, 400,000 respirators, 50,000 anti-plague suits, and 105 portable artificial lung ventilation devices made in Kazakhstan.
India observed a record daily rise in coronavirus cases on Friday, bringing total new cases for the week to 1.57 million, according to Reuters.
India is now the second most corona-affected country with the overall cases standing at 21.49 million.
On May 4, Tokayev delivered a message to Indian Prime Minister Narendra Modi to express “deep solidarity with the Indian nation over the devastating COVID-19 surge in their country.”
The President noted that Kazakhstan is ready “to unite efforts with our Indian friends to contain the spread of the pandemic and provide every possible assistance in the spirit of enduring friendship and mutual support between our states.”
Earlier, it was reported that Kazakhstan will provide humanitarian aid that consists of 10,000 tons of flour to Kyrgyzstan.
“Guided by the principles of friendship, alliance and strategic partnership with Kyrgyzstan, President Kassym-Jomart Tokayev decided to provide humanitarian assistance to the fraternal Kyrgyz people on behalf of the Kazakh people,” President’s spokesperson Berik Uali wrote on his Facebook on May 6.
India: EU mobilizes an initial €2.2 million in emergency funding for the vulnerable during COVID-19
The Commission has announced that it will allocate an initial €2.2 million in emergency funding to respond to the drastic surge in COVID-19 cases in India. The funding will support the World Health Organization (WHO) for a 6-month case management of COVID-19 patients, as well as strengthening laboratory capacity for COVID-19 testing. Crisis Management Commissioner Janez Lenarčič said: “We are providing additional EU support towards the fight against COVID-19 in India. This comes on top of the generous and swift assistance from EU member states that stepped up as part of Team Europe to offer critical supplies of oxygen, ventilators and medicines over the last few days. We stand ready to work with the WHO and other partners on the ground to jointly fight this battle at this difficult time – we are stronger together.”
Member states have already mobilized supplies of urgently needed oxygen, ventilators and medicines from Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Portugal, Romania, Spain and Sweden to India over the last week via the EU Civil Protection Mechanism.
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