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EMA receives application for conditional marketing authorization of COVID-19 Vaccine AstraZeneca

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EMA has received an application for conditional marketing authorization (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted.

Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data from laboratory studies (non-clinical data), data on the vaccine’s quality (on its ingredients and the way it is manufactured) and some evidence on safety and efficacy from a pooled analysis of interim clinical data from four ongoing clinical trials in the United Kingdom, Brazil and South Africa. Additional scientific information on issues related to quality, safety and efficacy of the vaccine was also provided by the company at the request of CHMP and is currently being assessed.

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?

EU legislation foresees that conditional marketing authorisation (CMA) is used as the fast-track authorisation procedure to speed up approval of treatments and vaccines during public health emergencies. 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. However, the data must show that the benefits of the medicine or vaccine outweigh any risks. A CMA guarantees that the approved medicine or vaccine meets rigorous EU standards for safety, efficacy and quality and is manufactured and controlled in approved, certified facilities in line with high pharmaceutical standards that are compatible with large-scale commercialisation. 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 the vaccine expected to work?

COVID-19 Vaccine AstraZeneca is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause disease.

COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. The adenovirus itself cannot reproduce and does not cause disease. Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defences − antibodies and T cells − against this protein. 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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Kyriakides says newly proposed schedule of AstraZeneca ‘not acceptable’

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Following AstraZeneca's statement (22 January) that it would not be able to meet its delivery schedule agreed with the EU for its COVID-19 vaccine, Health Commissioner Stella Kyriakides said that the European Union has pre-financed the development of the vaccine and the production and wants to see the return. She said the new schedule is not acceptable to the European Union.

It is anticipated that the European Medicines Agency (EMA) will grant approval to the AstraZeneca vaccine by the end of the week, currently scheduled for a meeting on 29 January. Though there are some questions of the vaccine’s efficacy with those over 50, it is logistically less challenging than the other vaccines as it does not require storage at very low temperatures. 

AstraZeneca informed the Commission last Friday (22 January) that it intends to supply considerably fewer doses than planned in the coming weeks than agreed and announced.

The European Union has pre-financed the development of the vaccine. 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.

The joint steering board of the Commission and the 27 member states discussed this with AstraZeneca today. Kyriakides said that the answers of the company have not been satisfactory so far, and that a second meeting is scheduled for tonight (25 January).

The Commission has today proposed to the 27 Mmember states in the Steering Board that an export transparency mechanism will be put in place as soon as possible.

The European Union has supported the rapid development and production of several vaccines against COVID-19 with a total of €2.7 billion. In future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries. The commissioner added that humanitarian deliveries would not be affected by this.

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WHO says Pfizer deal could allow poor countries to start vaccinating in February

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The World Health Organization said on Friday (22 January) it had reached an agreement with Pfizer/BioNTech for 40 million doses of its COVID-19 vaccine and should be able to start delivering vaccines to poor and lower-middle income countries next month under its COVAX programme, write and

The COVAX scheme, led by the WHO and the GAVI vaccine alliance, signed deals for hundreds of millions of doses to vaccinate people in poor and lower-middle income countries, but vaccinations have yet to start. Pfizer’s vaccine is so far the only one that has WHO emergency approval.

“In this world we are as protected as our neighbour,” said Pfizer’s CEO Albert Bourla, officially announcing the deal which Reuters reported on Thursday.

Bourla said the 40 million doses, a fraction of the company’s total 2021 production estimate of 2 billion, would be sold on a non-profit basis. He described it as an initial agreement, and said more doses could be provided through the COVAX programme in future.

The deal comes amid growing criticism of vaccine inequity from both the WHO and others as wealthy countries inoculate millions of people using shots procured through bilateral deals.

WHO Director-General Tedros Adhanom Ghebreyesus said that the new agreement with Pfizer should allow vaccinations to begin in February for health workers, although details of supply arrangements are still being finalised.

He said he hoped the agreement would also encourage other countries to donate more of their Pfizer shots to support rapid roll-out, like Norway has.

“The commitment of the (United States) to join COVAX, together with this new agreement with Pfizer/BioNTech, mean that we are closer to fulfilling the promise of COVAX,” he said.

U.S. President Joe Biden’s chief medical adviser Anthony Fauci said on Thursday the United States intended to join the facility. Biden’s predecessor Donald Trump had halted funding to the Geneva-based body and announced a withdrawal process.

The WHO said earlier this week it planned to deliver 135 million vaccines in the first quarter of 2021, without giving a breakdown by supplier.

GAVI’s CEO Seth Berkley said in the same briefing that countries would receive dose estimates for the early part of this year in about a week’s time.

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COVID-19 vaccinations: More solidarity and transparency needed 

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MEPs supported the EU's common approach to fighting COVID-19 and called for more unity and clarity during a debate on the roll-out of vaccines and the EU's vaccines strategy.

During a plenary debate on 19 January about the EU’s strategy on Covid-19 vaccinations, most MEPs expressed support for the EU's common approach, which ensured the quick development and access to safe vaccines. However, they called for even more solidarity when it comes to vaccinations and transparency regarding contracts with pharmaceutical companies.

Esther de Lange (EPP, Netherlands) said: “Only more transparency can take away the widespread perception – whether this is justified or not – that often, too often, profit is put before people in this (pharmaceutical) industry.” She praised the EU's joint purchase of vaccines, which led to a stronger negotiation position than individual EU countries would have had: “That means more vaccines for a better price and under better conditions. It shows what Europe can do when we stand united. We can help save lives.”

Iratxe García Pérez (S&D, Spain) warned against "health nationalism" that could damage cooperation on vaccines in Europe. According to her, solidarity and unity is the answer: “If we can keep unity and have equitable distribution of vaccines in member states, we have reasons to believe that 380 million European citizens will be vaccinated by the summer. This is a scientific and health feat that cannot be ruined by parallel contracts and direct purchases." She added: "Let us speak with one voice so that the largest vaccination campaign in history will bring hope back to us in 2021.”

“What are we doing exactly to increase the speed of administering vaccines across the EU?” asked Dacian Cioloș (Renew, Romania). “I know this is a race against time, but in this race we cannot forget that we have a responsibility to do things in full transparency, a responsibility to our citizens to gain their trust. That trust is largely what the vaccination campaign depends on."

Joëlle Mélin (ID, France) said the negotiation of the vaccine contracts lacked transparency. “We are now in the distribution phase and we discover that there are shortages and broken promises from the pharmaceutical companies,” she added.

Philippe Lamberts (Greens/EFA) also talked about the need for transparency and the fact that the European Commission kept the contracts with laboratories secret: “This opaqueness is an insult to democracy. In every single contract the buyer has to know what he or she is buying at what conditions and what price.” He also spoke about potential liability issues: “It is crucial to know who will hold the liability if there were to be negative side effects of the vaccination - would it be the public decision makers or would it be the drug makers? We have no idea.”

Joanna Kopcińska (ECR, Poland) said the decision for the common vaccination strategy was right: “We need an overarching strategy and of course scepticism has a lot to do with a fear that the vaccination is moving slowly, the delivery is maybe late and the contracts are not transparent." She called for the systematic update of treatment strategies and appropriate information campaigns that reach out to everyone.

Marc Botenga (The Left, Belgium) called for more transparency of contracts and responsibility from pharmaceutical companies. He criticised uneven access to vaccines globally, noting poorer regions have difficulties obtaining enough vaccines. “No profit needs to be made on this pandemic and we certainly do not want segregation at vaccinations.”

Plenary debate on the EU global strategy on Covid-19 vaccinations Some of the speakers during the debate on COVID-19 vaccinations  

Health Commissioner Stella Kyriakides assured MEPs that their calls for transparency had been heard. She welcomed the fact that the first of the vaccine suppliers had agreed to make the text of their contract available and said the Commission was working to get other producers to do the same.

Kyriakides said she expects to see more applications for the authorisation of vaccines in the coming months. She stressed the importance of a global approach: “No country will be safe and no economy will truly recover until the virus is under control in all continents." She also talked about Covax - the global facility to ensure fair and universal access to Covid-19 vaccines that the EU helped to set up - which aims to purchase two billion doses by the end of 2021, including more than 1.3 billion for lower- and middle-income countries.

Ana Paula Zacarias, the Portuguese Secretary of State for European Affairs who was speaking on behalf of the Council, said the common EU approach, which sped up the process of developing, authorising and securing access to vaccines, must continue to ensure the availability and efficient rollout of vaccines in all member states.

Zacarias said that a number of issues still need to be resolved, including the format and role of the vaccination certificate, a common approach on the use and validation of antigen rapid tests and the mutual recognition of COVID-19 test results.

Backgound: Race for vaccines

From the very beginning of the coronavirus outbreak, the European Parliament has closely followed the vaccine research and development process. The EU coordinated a joint effort to secure the speedy deployment of vaccines against the disease, through the mobilization of hundreds of million euro for research projects and more flexible procedures. Parliament approved a temporary derogation from certain rules for clinical trials to allow vaccines to be developed faster.

MEPs on the health committee repeatedly highlighted the need for public trust in vaccines and the importance of fighting disinformation and asked for more transparency regarding vaccine contracts, authorization and deployment in the EU.

Under the EU Vaccines Strategy launched in June 2020, the Commission negotiated and concluded advance purchase agreements with vaccines developers on behalf of EU countries; the EU covers part of the costs faced by the producers in return for the right to buy a specified amount of vaccine doses in a given timeframe and at a given price, once they are granted market authorisation. So far, six contracts with pharmaceutical companies have been concluded.

After scientific evaluation and positive recommendation by the European Medicines Agency, the European Commission  granted conditional market authorisation to the first vaccine against Covid-19, developed by BioNTech and Pfizer, on 21 December 2020. Vaccinations across the EU started shortly afterwards on 27 December. On 6 January 2021, Moderna’s vaccine was given conditional market authorisation. The vaccine developed by AstraZeneca could be authorised by the end of January.

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