The European Medicines Agency calls the AstraZeneca vaccine a “safe and effective vaccine”

Yesterday, in a much anticipated but not surprising announcement, European Medicines Agency (EMA) Executive Director Emer Cooke told reporters, “This [the Astra Zeneca COVID-19 vaccine] is a safe and effective vaccine.” Over the last two weeks, in succession, 13 European countries, including Germany, France, Spain and Italy, had suspended their COVID-19 vaccination campaign over fears raised in the press of reported blood clots in people after receiving the AstraZeneca vaccine.

The Medicines Health Regulatory Authority, which had been conducting its investigation reviewing the data on a small number of blood clot events in over 11 million people who were vaccinated in the UK, reported that it had reached the same conclusions regarding AstraZeneca’s vaccine.

A vial of AstraZeneca vaccine is pictured in a pharmacy in Boulogne Billancourt, outside Paris, Monday, March 15, 2021. (AP Photo/Christophe Ena)

Yet, despite repeated cautions against suspending vaccinations and reassurances by several national and global health agencies, including the World Health Organization (WHO), that the number of blood clot cases was far below the general background levels, countries like Italy and France chose to wait until the EMA verdict was out.

More than 20 million vaccinations have been administered over the intervening three months since the vaccine received emergency use authorization. Out of this, 37 blood clots developed in people within days of receiving their inoculation, of which four have died: two in Norway, one in Denmark and one in Italy. These deaths are currently being investigated.

However, the annual incidence of blood clots in the population is approximately one in 1,000. In other words, about 15,000 to 20,000 blood clots could be expected in the vaccinated population. Providing some scale to this medical condition, in the United States, unrelated to the vaccine issue, about 300,000 to 600,000 people each year develop such clotting complications, called deep vein thrombosis or pulmonary embolism.

Dr. Stephan Moll, a hematologist at the University of North Carolina, told the New York Times, “Only if epidemiological data show that the rate is higher, would one start to wonder about a causative relationship.” In contrast, in Europe, approximately 3,500 people are dying each day from COVID-19.

Emer Cooke added, “Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the possible risks.” She continued to explain that the expert committee on medicine safety found that “the vaccine is not associated with an increase in the overall risk of blood clots.” The committee chair, Dr. Sabine Straus, noted that as blood clotting complications are associated with COVID-19 infections, the vaccine “likely reduces the risks of thrombotic incidents overall.”

However, they stipulated one caveat regarding a “small number of rare and unusual cases, but very serious clotting disorder … [the EMA] still cannot rule out definitively a link” between these rare blood clots and the vaccine.

This is in reference to 18 cases of cerebral venous thrombosis, blood clots that develop in a cerebral vein in the brain responsible for draining blood from the brain. Such complications can lead to bleeding into the brain or severe swelling. It has also been described in patients with complications of their COVID-19 infections. Additionally, there were seven cases of having multiple blood clots.

The incidence of adult cerebral venous thrombosis is around 13 per million per year, twice that rate in women between 31 and 50. Most of the cases coincidental with the vaccine administration occurred in people under 55, the majority being women. The investigations into these will be ongoing.

The EMA has advised that public health awareness of these possible risks be raised and included in the product information. She concluded her brief, “If it were me, I would be vaccinated tomorrow. But I would want to know that if anything happened to me after vaccination, what I should do about it, and that’s what we’re saying here today.”

Italy’s Prime Minister Mario Draghi, responding to the EMA announcement, said that he would resume the vaccination campaign effective Friday. French Prime Minister Jean Castex publicized that he would get the AstraZeneca vaccine as a show of confidence, while also proclaiming that new restrictions would be imposed in Paris and surrounding regions to stem the rising tide of COVID infections.

Germany has joined in calling for a resumption of vaccinations, according to Health Minister Jens Spahn. Sweden told the BBC it would take a few more days to decide. Of note, the WHO said it was releasing the results of its independent investigation Friday.

Yet, as countries resume their vaccination campaigns, it is very probable that public confidence in the AstraZeneca vaccine may be irreparable. The initial slow vaccine rollout followed by the bitter infighting between the European Union and the UK over supply and distribution issues leading to inappropriately characterizing the vaccine as inducing blood clots have only compounded the lack of confidence. By all expert accounts and recent studies, Pfizer and AstraZeneca COVID-19 vaccines appear to perform similarly in preventing hospitalizations in the population. These effectiveness trials assessing the prevention of severe disease and death are most critical as are continued safety studies.

Yet the political brinksmanship of governments and the underlying contradictions exposed by the pandemic in the organization of nation-states under a capitalist economic base cannot muster the necessary cooperation to fight against the ravages of the contagion and protect the lives and livelihood of their populations.

In 11 months since first identifying the SARS-CoV-2 virus, several efficacious vaccines were rapidly developed to be able to protect people from the COVID-19 illness, a feat not many thought possible. Now that such a life-saving treatment is available, it has been the profit motive, national interests and pernicious rivalry that have served as an obstruction to the rapid delivery of these vaccines under an international principle of equity and necessity.

In this sense, science has become a severe casualty of politics. Vaccine hesitancy is deeply and concretely rooted in the degeneration of capitalist social relations that have disconnected science from its inherent philosophical principles.

In Denmark, signs of COVID fatigue have provoked anti-lockdown protests. Concerns over virus variants and the slow vaccine rollout are creating heightened social tensions. In France, where the AstraZeneca vaccine has overtaken Pfizer, a survey conducted by Elabe found French confidence in the AstraZeneca vaccine at 20 percent. Germany must rely on the AstraZeneca vaccine in the midst of a third wave if it expects to speed its vaccination program. Many of Germany’s health care workers are openly rejecting the AstraZeneca vaccine.

There are currently 15 million unused vaccines, according to the European Center for Disease Prevention and Control (CDC), predominantly in France and Germany. Out of the 62.2 million vaccine doses that have been delivered, 46.8 million have been administered. Overall, nine percent of the EU have received their first dose. The EMA is presently in the process of reviewing Russia’s Sputnik V vaccine.

As these current events have unfolded, European Commission President Ursula von der Leyen has warned that she was ready to introduce emergency controls on COVID-19 vaccine production and distribution to “ensure that Europeans are vaccinated as soon as possible.” She has even warned of invoking Article 122 of the EU’s treaty, allowing it to use emergency measures to secure the necessary vaccine supplies.

According to the Financial Times, “[T]he EU’s 27 heads of state and government are due to hold talks on vaccines at a summit next week.” Such measures will further aggravate vaccine nationalism, prolonging the pandemic and misery around the globe and geopolitical rivalries.