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European Medicines Agency authorizes BioNTech/Pfizer COVID vaccine

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EMA has recommended granting a conditional marketing authorization for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorization of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.

EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorization. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”

A very large clinical trial showed that Comirnaty was effective at preventing COVID‑19 in people from 16 years of age.

The trial involved around 44,000 people in total. Half received the vaccine and half were given a dummy injection. People did not know whether they received the vaccine or the dummy injection.

Efficacy was calculated in over 36,000 people from 16 years of age (including people over 75 years of age) who had no sign of previous infection. The study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (8 cases out of 18,198 got COVID-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got COVID-19 symptoms). This means that the vaccine demonstrated a 95% efficacy in the clinical trial.

The trial also showed around 95% efficacy in the participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2. The high efficacy was maintained across genders, racial and ethnic groups.

Comirnaty is given as two injections into the arm, at least 21 days apart. The most common side effects with Comirnaty were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the member states, through the EU pharmacovigilance system and additional studies by the company and by European authorities.

Where to find more information

The PDF iconproduct information approved by the CHMP for Comirnaty contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.

An assessment report, with details of EMA’s evaluation of Comirnaty, and the full risk management plan will be published within days. Clinical trial data submitted by the company in the application for marketing authorization will be published on the Agency’s clinical data website in due course.

More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks and why EMA recommended its authorisation in the EU.

How Comirnaty works

Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.

The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.

Conditional marketing authorization

A conditional marketing authorization is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic.

conditional marketing authorization is a formal authorization of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns.

As Comirnaty is recommended for a conditional marketing authorization, the company that markets Comirnaty will continue to provide results from the main trial, which is ongoing for 2 years. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up.

Monitoring the safety of Comirnaty

In line with the EU’s safety monitoring plan for COVID-19 vaccines, Comirnaty will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.

Companies are required to provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public. Authorities will also conduct additional studies to monitor the vaccines.

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.

Assessment of Comirnaty

During the assessment of Comirnaty, the CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of Comirnaty, and the COVID-19 EMA pandemic task force (COVID-ETF), 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.

The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Comirnaty, allowing vaccination programmes to be rolled out across the EU.

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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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