«We are focused on providing a safe and effective vaccine. Not for profit, but to defeat the pandemic »- director of AstraZeneka in Poland on the controversy surrounding the product

We do not compromise on safety, the parameter (tests for thrombosis) is constantly monitored, which is why we expected such opinion from the regulators – comments Piotr Najbuk, director of external relations at AstraZeneca, commented on the verdicts of the European agency EMA and the British MRHA.

1. – Analyzes confirm that the benefits of AstraZeneca against COVID-19 outweigh the risks associated with side effects, especially considering the risk of hospitalization and death associated with the COVID-19 disease itself – explains Piotr Najbuk
2. – We conducted a thorough review of data from over 17 million people vaccinated in the European Union and the UK. These analyzes showed that there is no increased risk of thromboembolic events or thrombocytopenia after vaccination, regardless of the age group, sex, batch or region used, he explains.
3. Recall that after individual deaths, many countries have decided to temporarily suspend vaccination with AstraZeneki, fearing that it increases the risk of blood clots.
4. – Despite export restrictions, we have delivered over 1 million 200 thousand to Poland. vaccines. Considering that 3,2 million people have now been vaccinated in our country with the first dose and 1,7 million people with the second dose of the vaccine, our contribution to the Polish program is high – explains Piotr Najbuk
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Christian Hartel, head of the German chemical company Wacker, has publicly suggested that the CureVac vaccine could ease the vaccination blockage caused by the temporary suspension of AstraZeneca. The following companies are also involved in this project: Bayer, Novartis and GlaxoSmithKline. The European Medicines Agency (EMA) may give a positive opinion to CureVac in April. On the one hand, a campaign depreciating the safety of the AZ vaccine, and on the other hand, accelerated processes in the EMA related to the new German vaccine. How do you comment on this?

Piotr Najbuk, AstraZeneca External Relations Director: We will not comment on the actions or words of other companies. It is crucial that information on vaccines, including our preparation, is based on scientific knowledge, research results and the positions of independent institutions appointed to assess their safety and effectiveness – such as the European Medicines Agency. The goal remains common – to protect as many people as possible from the consequences of contracting COVID-19 – regardless of which company is given the vaccine.

Najbuk: We want to deliver 2021 million doses to the EU in the first half of 100

The European Commission has serious concerns about the fulfillment of orders for the AstraZeneca COVID-19 vaccine. How many doses have you already delivered to the European Union, how many more will you deliver and when? Are there any further delays in connection with the planned deliveries? What can they result from?

To begin with, I must explain that the production processes of biological drugs are extremely complicated and usually their preparation takes a long time, sometimes even years. We conducted the production process on an industrial scale in parallel with the research work at the University of Oxford. The industrial production line was developed in just a few months.

To produce billions of doses of vaccine for countries around the world, we have built over a dozen regional supply chains, working with more than 20 partners in more than 15 countries. We work in extreme conditions imposed by the pandemic, which did not allow us to even stock up on vaccines before the start of deliveries. We are constantly optimizing processes and aligning the production capacity in individual plants.

1. AstraZeneca is safe and effective. Will we stop being afraid of this vaccine?

Despite our continued efforts to increase production, in the first quarter we will deliver less doses to the European Union than we originally declared. As previously reported, we are facing shortcomings in the European supply chain, resulting in lower than expected production. We intended to compensate for some of this shortfall by sourcing vaccines from an international network of suppliers. Unfortunately, export restrictions did not allow it.

Despite these challenges, we intend to deliver 100 million doses to the European Union in the first half of 2021, of which 30 million are to be delivered in the first quarter. We are working with the European Commission and Member States to solve supply problems. We are confident that the efficiency of the EU supply chain will continue to increase to help protect millions of Europeans from the virus.

Despite these limitations, our vaccines make a significant contribution to national immunization programs and make an important contribution to the fight against the pandemic.

When it comes to specific data for Poland, despite export restrictions, we delivered over 1 million 200 thousand. vaccines. Considering that 3,2 million people have been vaccinated with the first dose and 1,7 million people with the second dose of the vaccine in our country, our contribution to the Polish program is high.

We expect a significant supply of over 500 vaccines in the next several days, which will enable the continuation of the National Immunization Program.

1. The benefits of vaccinating with AstraZeneca outweigh the risks

We stand shoulder to shoulder in the fight against the pandemic

“The AstraZeneca COVID-19 vaccine can help reduce the spread of the coronavirus as well or almost as well as other vaccines,” Prime Minister Mateusz Morawiecki recently stated. A day later, British Prime Minister Boris Johnson vaccinated himself with this preparation. Did you expect such support from the heads of state?

At the end of last year, many heads of state and government made similar gestures. It is extremely important that science and government speak with one voice in building confidence in vaccination. Fighting the pandemic requires extraordinary determination and commitment from many environments, and we stand shoulder to shoulder in it. As experts emphasize, we do not currently have a more effective way to fight the pandemic than universal vaccination. That is why we joined forces with the University of Oxford to create a unique partnership that led to the creation of a safe and effective vaccine, as evidenced by both clinical studies and further data from vaccination programs in individual countries.

On January 29, EMA officially recommended that AstraZeneca be given conditional marketing authorization for people aged 18 years and over. Where did this conditionality come from?

Conditional Marketing Authorization is an accelerated authorization procedure with the aim of making treatments and vaccines available more quickly in public health emergencies in the European Union. “Conditionality” means that a marketing authorization is granted to drugs whose effectiveness and, above all, the safety profile are confirmed, but the data submitted to the EMA is not as extensive as in the case of the normal procedure. Therefore, products that receive conditional marketing authorizations remain in the third phase of clinical trials, are tested and additionally monitored.

For our vaccine, approval was based on the combined results of 4 clinical trials conducted in the UK, Brazil and South Africa. Almost 24 people participated in these studies. They showed that the vaccine was safe and effective in preventing SARS-CoV-000 infection in people 2 years of age and older.

These results are also confirmed by further data coming from various research centers and countries, such as the latest results of a phase III study from the USA, Chile and Peru.

Najbuk on the EMA decision: our role is not to comment

After its approval, however, controversy grew over the possible side effects of AstraZeneca. After, inter alia, Germany, France and Spain have suspended vaccination with this preparation, EMA has issued a message that it will look at cases of thrombosis. At the same time, the World Health Organization (WHO) called for the continued administration of the vaccine. Why did EMA decide to test only your vaccine, while similar events have also occurred with other vaccines?

EMA is looking at the safety profiles of all approved vaccines. Our role is not to comment on decisions made by the European Medicines Agency or any other regulator. We are focused on delivering a safe and effective vaccine worldwide. Not for profit, but to defeat the pandemic – the amount countries and international organizations pay for AstraZeneca only covers costs, including delivery and installation of production technologies, production and supervision as well as delivery costs. This is a huge challenge. However, we are determined and we are working hard to keep this commitment.

1. AstraZeneca and the risk of thrombosis. The three most important facts

We hope that the authority of the EMA and the conclusions of UK regulators will help to cool down emotions, increasing confidence in vaccination. The analyzes carried out confirm that the benefits of AstraZeneca against COVID-19 outweigh the risks associated with side effects, especially when you consider the risk of hospitalization and death associated with COVID-19 disease itself.

Have the countries that suspended AstraZeneca vaccinations also suspended orders? Can these vaccines go to other countries – for example to Poland?

To our knowledge, deliveries to these countries have not been stopped. It is solely up to those countries to distribute vaccines by recipient countries.

On March 16, the head of the EMA Emer Cooke announced that the available data did not directly confirm that vaccines caused blood clots. Of the 3 million vaccinations carried out in Europe, a total of 22 cases of thrombosis have been reported. Cooke estimated that the number of thromboembolic events in vaccinated people did not appear to be higher than in the general population. However, she emphasized that the Agency will carefully investigate all reports. Two days later, the EMA Safety Committee officially assessed AstraZeneca’s vaccines as safe. The committee summarized information about the vaccine, but also about the risk of side effects it can cause. A similar decision was made by the British supervisory authority MRHA. Did you expect such a verdict?

We do not compromise on safety, this parameter is constantly monitored, which is why we expected such feedback from the regulators. The best specialists from the University of Oxford and AstraZeneca worked on the vaccine, and we placed the highest priority on safety at every step: both during the development and production of the vaccine, and during clinical trials and post-marketing. In the case of population vaccinations, the safety oversight process also includes the preparation of monthly reports for the relevant authorities. We collect, analyze and report data on adverse events on an ongoing basis and share them.

1. Vaccinations with AstraZenecą. What did the head of the European Medicines Agency say?

We conducted a thorough review of our safety data from over 17 million people vaccinated in the European Union and the UK, and we also analyzed the contested party’s documentation. These analyzes showed that there was no increased risk of thromboembolic events or thrombocytopenia following vaccination, irrespective of the age group, sex, lot or region analyzed.

There are similar conclusions from the United States. On March 25, we announced the results of the preliminary analysis of the phase III study. The data show that the vaccine was 76% effective in preventing symptomatic COVID-19. As well as 100% it protects against the severe course of this disease. The 85% effectiveness of the vaccine was also reported in the group of people aged 65 and over, who constituted approximately 20% of the study participants. At the same time, there was no increased risk of thrombosis or thrombotic events.

All vaccine recipients can rest assured that the preparation has been found to be generally well tolerated and effective in preventing symptomatic COVID-19 based on very rigorous clinical trials. This is also confirmed by the analyzes of the actual effectiveness assessed under the vaccination programs carried out so far.

But there are still signals from all over the world that vaccinations are being canceled amid concerns over vaccine safety. Some countries have suspended immunization temporarily, others are dropping your vaccine. The Polish government even decided to allow subsequent years in order not to suspend the vaccination program. How will you convince these people that they should register and get vaccinated with AstraZeneca without fear?

Each medicinal product placed on the market must meet stringent efficacy and safety requirements. Vaccines are currently the best tool in the fight against the pandemic and the global health crisis it is causing. As a company, we join the appeals of experts and public representatives and encourage them to act in accordance with their guidelines. There is no doubt that vaccines save our lives and health.

It is worth quoting here the results of a study conducted by the University of Edinburgh in cooperation with the Scottish health service. Analyzing data from the national immunization program, it has been shown that our vaccine is able to reduce the risk of hospitalization associated with SARS-CoV-2 infection by 94% after the first dose.

1. The death of Dunki stopped the AstrZeneka vaccination. What do we know about its causes?

It is crucial that we base our discussions on vaccines on solid scientific data and current medical knowledge. Regulatory bodies and international organizations relied on them, indicating that the vaccine is effective and its safety profile has been confirmed. We shared the available data on an ongoing basis with the authorities in Poland, with whom we conduct an open, substantive and partnership-based dialogue. This enabled independent government experts to make a decision based on scientific evidence and allowed the continuation of the vaccination program and increasing the safety of Poles. Thousands of patients vaccinated in recent weeks can avoid severe disease, complications and death.

Recently, the Polish company Mabion received PLN 40 million in support from the Polish Development Fund and signed a contract for the production of Novavax vaccines in Poland. But the Polish government is negotiating the launch of new production lines for Covid-19 vaccines in our country. There is also supposedly AstraZeneca in the game. Do you confirm this information? If so, when and in cooperation with which entity could such a line be launched?

Indeed, talks are underway with both Polish authorities and companies to establish production capacities in Poland. The arrangements are at an early stage, but we are pleased with the interest and openness of partners on the public side. We know that we are united by a common goal and we conduct talks in this spirit. At the same time, we must remember that the issues of producing this type of preparation are very complex, so we will have to wait for the effects.

This is not just an action we are taking to increase the availability of our vaccine. We have launched knowledge sharing processes with new partners across the global network, which has significantly reduced the performance gap between our production plants. We are still working literally 24/7 to achieve our target performance at all sites. Secondly, we are making significant investments in new production capacity in Europe, for example through our partnership with IDT Biologika in Germany. Finally, we mobilize production partners outside the EU to ensure additional drug supply streams.

Wojciech Surmacz interviewed

Read also:

1. AstraZeneca is 100% protects against the severe course of COVID-19
2. Pfizer, Moderna, AstraZeneca, J&J – what are the side effects?
3. What symptoms after vaccination should worry us? Microbiologist lists

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