European Medicines Agency continues to endorse the safety of the AstraZeneca COVID-19 vaccine

As of yesterday, more than a dozen European countries, including Germany and France on Monday and Sweden and Latvia on Tuesday, have suspended their vaccination programs using the AstraZeneca COVID-19 vaccine over recent reports of people developing blood clots soon after being inoculated. Some have died.

Thromboembolic events are not uncommon, especially among older adults with health conditions such as obesity, heart disease or cancer. Blood clots can form in the legs or even arms, and some can travel to the lung, causing a pulmonary embolism which can have dire consequences or be fatal.

In general, the annual incidence of thromboembolic events is approximately 1 in 1,000. The risk begins to rise after 45, reaching five- to six-fold higher in people approaching 80 years of age. However, the recent reports of a small number of brain clots from Germany have further raised concerns among health officials about the product’s safety.

According to the vaccine maker, 37 such events have been reported among 17 million people who have received the vaccine. According to Reuters, the European Medicines Agency (EMA) is investigating reports into 30 cases among 5 million people who have received the AstraZeneca vaccine. The EU regulators are expected to release the results of their investigation on Thursday. For certain, they will be examining the rates of blood clots in the general population compared to those vaccinated. Additionally, investigations are taking place into possible manufacturing defects.

Dr. Penelope Ward, professor of pharmaceutical medicine at King’s College London, placed this in context in speaking with the Financial Times: “In the UK, about 165 people a day might suffer a thrombotic episode, some of which will be fatal. In contrast, the number of reports from the ongoing vaccine program in the UK and EU, which includes 20 million individuals vaccinated to date, is just 37. By chance alone, at least 15,000 such events might have been expected from a population this size.”

Meanwhile, 2.68 million deaths from COVID-19 have occurred globally, with over 850,000 of these just in Europe. The weekly number of deaths attributed to infections remains high, at more than 20,000.

The World Health Organization (WHO) has continued to stand by its position that there have been no deaths causally linked to COVID-19 vaccines and has raised concerns that the suspension of these vaccination programs will lead to additional unnecessary deaths, considering the spread of more virulent variants of the coronavirus. It said yesterday, “As of today, there is no evidence that the vaccine causes the incidents, and vaccination campaigns must continue so that we can save lives and stem severe disease from the virus.”

On the news that France, Germany, Italy and Spain had coordinated their decisions to halt their vaccination programs with the vaccine from AstraZeneca, EMA Executive Director Emer Cooke, speaking at a conference yesterday, said, “It is inevitable that you have rare or serious incidences of illnesses that occur after vaccinations. Our role at EMA is to evaluate these to make sure that any suspected adverse reactions are rapidly investigated so we can figure out is this a real side effect to the vaccine or is it a coincidence? The number of thromboembolic events overall in the vaccinated people seems not to be higher than that seen in the general population. Trust in the safety and the efficacy of the vaccine that we have authorized is paramount for us. And our job is to make sure that we can maintain trust in these vaccines based on a proper scientific evaluation.”

She then added, “Currently, we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risks of hospitalizations and death outweigh the risk of these side effects.” It should be noted that during the efficacy vaccine trials, Oxford/AstraZeneca had reported there had been five serious adverse events in those who were vaccinated. Still, none were found to have been caused by the vaccines.

Italy’s prime minister, Mario Draghi, told the Guardian that he and French President Emmanuel Macron had spoken, agreeing to resume their vaccination programs once they received confirmation of the vaccine’s safety from the EMA. Agnès Pannier-Runacher, a French business executive serving as secretary of state for economy and finance, told the Financial Times that there was nothing dubious in the coordinated effort to suspend their vaccination programs. “If you see a decision being made in other countries, the risk is that a mistrust of the vaccine could develop. Our intention is to be perfectly transparent and [show] that every time that there is an alert, we treat it as professionally as possible.”

As these events were unfolding, the European Commission announced yesterday that it agreed with Pfizer-BioNTech on an accelerated delivery of 10 million doses in the second quarter. Commission President Ursula von der Leyen said, “I know how critical quarter two is for the rollout of our vaccination strategies in the member states. These accelerated 10 million doses will bring the total doses of BioNTech-Pfizer in quarter two up to over 200 million. This is very good news. It gives member states room to maneuver and possibly fill gaps in deliveries.”

The suspension of vaccination with AstraZeneca’s COVID-19 vaccine takes place against countries’ backdrop of using vaccines as a cudgel for geopolitical interests. While the US has distributed 143 million doses of COVID-19 vaccines and 45 million have been distributed in Europe, low- and middle-income countries continue to wait for vaccines through the WHO COVAX facility.

Dr. Michael Osterholm, in an article published in Foreign Affairs last week, wrote, “In February, United Nations Secretary-General Antonio Guterres announced that 10 countries had administered 75 percent of the world’s available COVID-19 vaccine supply. At the time, more than 130 countries, home to 2.5 billion people, had yet to receive a single dose of any vaccine, rendering them vulnerable to new variants.”

A study commissioned by the International Chamber of Commerce Research Foundation found that the global economy could lose as much as $9.2 trillion “if governments fail to ensure developing economy access to COVID-19 vaccines, as much as half of which would fall on advanced economies.” The dangers of vaccine nationalism will have serious geopolitical consequences soon for vast numbers of working people. It only underscores the inability of capitalism to address the most basic needs of humanity.