The Netherlands and Ireland joint the list of countries that have temporarily stopped using the AstraZeneca-Oxford COVID-19 vaccine, as World Health Organization (WHO) experts review the findings.
Meanwhile, AstraZeneca yesterday said there is no evidence supporting a link between the vaccine and thrombotic (clotting) or bleeding events.
WHO, EMA probes continue
The pauses are leading to delays in rolling out the vaccine, compounding already slow progress in some countries—a worry, given the rapid spread of more transmissible SARS-CoV-2 variants.
In announcing the pause yesterday, Dutch officials, who had earlier said there is no reason to pause vaccination, said they couldn’t allow any doubts about the vaccine, though there is no proof of a direct link, according to Reuters.
Officials took the step following reports that surfaced on Mar 13 of three health workers who were treated for bleeding, blood clots, and low blood platelet count after receiving the vaccine.
The European Medicines Agency (EMA) said last week that its preliminary investigation found no link between the vaccine and thromboembolism and other related issues, and today it said its probe continued over the weekend and the safety committee will meet twice this week to make conclusions.
It repeated that the number of thromboembolic events in vaccinated people doesn’t appear to be higher than for the general population.
Though countries have temporarily paused vaccination while the EMA investigates, the group said the benefits of vaccination against hospitalization and death still outweigh any side effect risks.
At a WHO briefing today, Mariangela Simao, MD, MSc, assistant director-general for access to medicines and health products, said the WHO has its own pharmacovigilance in place and is working closely with the EMA. She also said the WHO’s global advisory committee on vaccine safety meets tomorrow.
Soumya Swaminathan, MD, the WHO’s chief scientist, said 300 million doses of COVID-19 vaccine have been given and there are no documented deaths linked to any of the vaccines. “We don’t want people to panic,” she said, adding that the WHO recommends that countries continue vaccinating their populations.
Company review finds no link
Yesterday, AstraZeneca said a careful review of all safety data on more than 17 million people who have been vaccinated in the European Union and the United Kingdom has found no evidence of pulmonary embolism, deep vein thrombosis (DVT), or thrombocytopenia in any patient population or for any vaccine batch.
It said in the EU and UK there have been reports of 15 DVT events and 22 pulmonary embolism events in people vaccinated as of Mar 8, which it says reflects a level that is much lower than the general population and is similar to other licensed COVID-19 vaccines.
The company added that the number of thromboembolic events in clinical trials was also lower in the vaccinated group, with no indication of increased bleeding among 60,000 participants.
WHO renews solidarity fund appeal
In other developments, the WHO today marked the first anniversary of its COVID-19 Solidarity Response Fund, which it said raised more than $242 million from more than 661,000 people, corporations, and organizations. It said, however, that it still needs another $1.96 billion to continue coordinating the pandemic response, with more than 60% earmarked for access to COVID-19 tools, including tests, treatments, and vaccines.
Mike Ryan, MD, who leads the WHO’s health emergencies program, said the world was in a difficult situation a year ago, and WHO funding was sparse, with people reacting in different ways. He said the creation of the fund provided a vital lifeline that drove the first part of the response, including food deployment and help for children and refugees. “These funds mattered. Your funds mattered.”
In other global headlines:
- In Europe, France’s health minister said hospitals are facing increasing pressure, with intensive care units at 82% capacity, the highest since November, and Italian health officials said virus activity rose 10% last week as much of the country entered another lockdown, while warning that the situation isn’t likely to improve until late spring.
- Four countries recently announced a Quad Vaccine Partnership to expand vaccine production and help Indo-Pacific countries with vaccination, the Biden Administration said in a Mar 12 statement. Part of the plan includes expanding vaccine manufacturing at facilities in India, with the United States, Japan, and Australia working on financing and logistics. The efforts will be coordinated with the WHO and COVAX.
- The global total today topped 120 million cases and reached 120,109,683 cases, and 2,657,729 people have died from their infections, according to the Johns Hopkins online dashboard.