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EMA receives application for conditional marketing authorization of COVID-19 mRNA vaccine BNT162b2 

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EMA has received an application for conditional marketing authorization (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.

Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available.

EMA will now assess the data submitted as part of the formal application for conditional marketing authorization. The Agency and its scientific committees will continue working on the assessment over the Christmas period. If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 29 December at the latest. These timelines are based on the type of data assessed so far in the context of the rolling review and may be subject to change as evaluation proceeds. EMA will communicate on the outcome of its assessment accordingly.

During the review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force, a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

What is a conditional marketing authorization?

In the EU, CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available. CMAs are being used in the context of the pandemic to promptly respond to the public health threat. However, the data must show that the benefits of the medicine or vaccine outweigh any risks. Once a CMA has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.

What may happen next?

If EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting a conditional marketing authorization. The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorization valid in all EU and EEA Member States within days.

As for all medicines, EU authorities continuously collect and review new information on medicines once they are on the market and take action when needed. In line with the EU safety monitoring plan for COVID-19 vaccines,  monitoring  will take place more frequently and will include activities that apply specifically to COVID-19 vaccines. Companies for example will provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness of COVID-19 vaccines after their authorisation.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed.

Key facts on COVID-19 vaccines and more information about how these vaccines are developed, authorised and monitored in the EU can be found on the EMA website.

How is BNT162b2 expected to work?

BNT162b2 is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. The virus uses a protein on its outer surface called a spike protein to enter the body’s cells and cause disease. BNT162b2 contains the genetic instructions (mRNA) to produce the spike protein. The mRNA is covered in small lipid (fat) particles that help deliver the mRNA into the cells and prevent it from being degraded. When a person is given the vaccine, their cells will read the genetic instructions and produce the spike protein. The person’s immune system will then treat this protein as foreign and produce natural defences — antibodies and T cells — against it. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be prepared to attack it: antibodies and T cells can work together to kill the virus, prevent its entry into the body’s cells and destroy infected cells, thus helping to protect against COVID-19.

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Dutch PM condemns lockdown riots as 'criminal violence'

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Dutch Prime Minister Mark Rutte (pictured) on Monday (25 January) condemned riots across the country at the weekend in which demonstrators attacked police and set fires to protest against a night-time curfew to slow the spread of the coronavirus, calling them “criminal violence”, writes .

The police said hundreds of people had been detained after incidents that began on Saturday evening and lasted until the early hours of Monday, including some in which rioters threw rocks and in one case knives at police and burned down a COVID-19 testing station.

“This has nothing to do with protest, this is criminal violence and we will treat it as such,” Rutte told reporters outside his office in The Hague.

Schools and non-essential shops in the Netherlands have been shut since mid-December, following the closure of bars and restaurants two months earlier.

Rutte’s government added the curfew as an additional lockdown measure from Saturday over fears that the British variant of COVID-19 may soon lead to an increase in cases.

There have been 13,540 deaths in the Netherlands from COVID-19 and 944,000 infections.

The police trade union NPB said there could be more protests ahead, as people grow increasingly frustrated with the country’s months-long lockdown.

“We haven’t seen so much violence in 40 years,” union board member Koen Simmers said on television program Nieuwsuur.

Police used water cannon, dogs and officers on horseback to disperse a protest in central Amsterdam on Sunday afternoon. Nearly 200 people, some of them throwing stones and fireworks, were detained in the city.

In the southern city of Eindhoven, looters plundered stores at the train station and set cars and bikes on fire.

When police said the demonstrators were violating the country’s current lockdown rules “they took weapons out of their pockets and immediately attacked the police”, Eindhoven Mayor John Jorritsma said.

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Head of French health regulatory body: COVID situation is 'worrying'

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The COVID-19 situation in France is worrying, the head of the country’s Haute Autorite de Sante (HAS) health regulator told France Inter radio on Monday (25 January), as President Emmanuel Macron’s government considers a new lockdown, write Sudip Kar-Gupta and Dominique Vidalon.

France has the world’s seventh-highest COVID-19 death toll, with more than 73,000 deaths.

“It is a worrying moment. We are looking at the figures, day by day. We need to take measures pretty quickly....but at the same time, not too hastily,” said HAS head Dominique Le Guludec.

Jean-François Delfraissy, head of the scientific council that advises the government on COVID-19, had said on Sunday that France probably needed a third national lockdown, perhaps as early as the February school holidays, because of the circulation of new variants of the virus.

French European Affairs Minister Clement Beaune, when asked about this on French radio on Monday, replied that no firm decision had been taken on the matter.

France is currently in a nationwide 18h to 6h curfew, in a bid to slow down the spread of the virus, but the average number of new infections has increased from 18,000 per day to more than 20,000.

Geoffroy Roux de Bézieux, head of the MEDEF French business lobby group, said he would call on the government to keep as many businesses and schools open as possible in any new lockdown, to protect the economy and help children’s education.

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EU urges AstraZeneca to speed up vaccine deliveries amid 'supply shock'

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The European Union has urged AstraZeneca to find ways to swiftly deliver vaccines after the company announced a large cut in supplies of its COVID-19 shot to the bloc, as news emerged the drugmaker also faced supply problems elsewhere, write and

In a sign of the EU’s frustration - after Pfizer also announced supply delays earlier in January - a senior EU official told Reuters the bloc would in the coming days require pharmaceutical companies to register COVID-19 vaccine exports.

AstraZeneca, which developed its shot with Oxford University, told the EU on Friday it could not meet agreed supply targets up to the end of March, with an EU official involved in the talks telling Reuters that meant a 60% cut to 31 million doses.

“We expect the company to find solutions and to exploit all possible flexibilities to deliver swiftly,” an EU Commission spokesman said, adding the head of the EU executive Ursula von der Leyen had a call earlier on Monday with AstraZeneca’s chief Pascal Soriot to remind him of the firm’s commitments.

A spokesman for AstraZeneca said Soriot told von der Leyen the company was doing everything it could to bring its vaccine to millions of Europeans as soon as possible.

News emerged on Monday that the company faces wider supply problems.

Australia’s Health Minister Greg Hunt told reporters AstraZeneca had advised the country it had experienced “a significant supply shock”, which would cut supplies in March below what was agreed. He did not provide figures.

Thailand’s Health Minister Anutin Charnvirakul said AstraZeneca would be supplying 150,000 doses instead of the 200,000 planned, and far less than the 1 million shots the country had initially requested.

AstraZeneca declined to comment on global supply issues.

The senior EU official said the bloc had a contractual right to check the company’s books to assess production and deliveries, a move that could imply the EU fears doses being diverted from Europe to other buyers outside the bloc.

AstraZeneca has received an upfront payment of 336 million euros ($409 million) from the EU, another official told Reuters when the 27-nation bloc sealed a supply deal with the company in August for at least 300 million doses - the first signed by the EU to secure COVID-19 shots..

Under advance purchase deals sealed during the pandemic, the EU makes down-payments to companies to secure doses, with the money expected to be mostly used to expand production capacity.

“Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” AstraZeneca said on Friday.

The site is a viral vectors factory in Belgium run by the drugmaker’s partner Novasep.

Viral vectors are produced in genetically modified living cells that have to be nurtured in bioreactors. The complex procedure requires fine-tuning of various inputs and variables to arrive at consistently high yields.

“The flimsy justification that there are difficulties in the EU supply chain but not elsewhere does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said EU lawmaker Peter Liese, who is from the same party as German Chancellor Angela Merkel.

The EU called a meeting with AstraZeneca after Friday’s (22 January) announcement to seek further clarification. The meeting started at 1230 CET on Monday.

The EU official involved in the talks with AstraZeneca said expectations were not high for the meeting, in which the company will be asked to better explain the delays.

Earlier in January, Pfizer, which is currently the largest supplier of COVID-19 vaccines to the EU, announced delays of nearly a month to its shipments, but hours later revised this to say the delays would last only a week.

EU contracts with vaccine makers are confidential, but the EU official involved in the talks did not rule out penalties for AstraZeneca, given the large revision to its commitments. However, the source did not elaborate on what could trigger the penalties. “We are not there yet,” the official added.

“AstraZeneca has been contractually obligated to produce since as early as October and they are apparently delivering to other parts of the world, including the UK without delay,” Liese said.

AstraZeneca’s vaccine is expected to be approved for use in the EU on Jan. 29, with first deliveries expected from 15 February.

($1 = €0.8214)

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