A review by the UK drugs regulator has found that by the end of March 79 people in the UK had suffered rare blood clots after vaccinations, with 19 of those passing away. The regulator said that this did not constitute proof that the jab caused the clots, but it did say the link was becoming firmer.
AstraZeneca’s vaccine is cheaper to produce than most of the alternatives and it can safely be stored at higher temperatures, but the blood clot story is just the latest in a line of misfires from the pharmaceutical firm.
First, there were issues with trial data and controversies over trials in which half doses were administered. There have also been questions over the safety and efficacy of the drug in the elderly, and French President Emmanuel Macron even brandished it ‘quasi-ineffective’.
“Over 20 million doses of the AZ vaccine have been given in the UK. And we know that vaccines are the best way to protect people from COVID-19 and have already saved thousands of lives. And in fact, around 6,000 modeled in the UK by the end of February, but no effective medicine or vaccine is without risk. And with vaccines more complex than usual because the benefits can be to people other than the individual taking the vaccine,” Professor Raine said at a press conference held by UK and EU regulators to discuss the AstraZeneca vaccine.
“Our role is to continually monitor safety during widespread use to confirm that the vaccines are performing as expected to identify any very rare side effects and to ensure the benefits outweigh the risks. The public’s safety is at the forefront of our minds. Our teams of safety experts, scientists, clinicians, and epidemiologists have investigated, reviewed, and evaluated thoroughly and scientifically all safety reports. And our safety rubric reviews are carried out in tandem with the vaccination program.
“We’ve gathered a large amount of data on the safety profile of the available vaccines, and we’ve done a rigorous scientific review of all the available data with regards to suspected blood clots with low platelet count.”
A Medicines and Healthcare products Regulatory Agency (MHRA) review found that the 79 cases and 19 deaths occurred after 20 million doses had been administered, meaning there is a risk of about four in one million of developing a blood clot, and one in a million of dying from it.
The review also found that nearly two-thirds of the cases were seen in women, while the people who died were all aged between 18 and 79, with three of them under the age of 30. Each of the recorded cases came after the first dose but because of the lower number of second doses, no conclusion should be drawn from this, according to the review.
“The Commission on Human Medicines Expert Working Group has also met frequently and critically assessed all the data alongside our regulatory review. And this has also included lay representatives and advice from leading hematologists,” Professor Raine continued. “Based on the current evidence, the benefits of the COVID-19 vaccine AstraZeneca against COVID-19 and its associated risks, hospitalization and death continues to outweigh the risks for the vast majority of people.
“Our review has reinforced that the risk of this rare suspected side effect remains extremely small. By the 31st of March, over 20 million doses having been given, we have had 79 case reports up to and including that date, 31st of March. All 79 cases occurred after the first dose. Of these 79 cases, 19 people have sadly died.
These cases occurred in 51 women and 28 men, age from 18 to 79 years. And from these reports, the risk of this type of rare blood clot is about four people in a million who received the vaccine. Three out of the 19 were under 30 years. 14 of the 19 were of the cerebral venous sinus thrombosis with low platelets and five were other kinds of thrombosis in major veins.”
The EU’s medicines regulator has announced that it believes unusual blood clots should now be listed as a possible rare side effect of the AstraZeneca jab, but also that the benefits outweigh the risks. Some European countries have already begun to restrict distribution of the vaccine.
The World Health Organization said that the links between the vaccine and blood clots were ‘plausible’ while not confirmed, adding that incidents of the clots were ‘very rare’ among the nearly 200 million people who have received the jab across the world.
“The balance of benefits and risks is very favorable for older people, but it is more finely balanced for the younger people. And we at the MHRA are advising that this evolving evidence should be taken into account when considering how the vaccine is used,” Professor Raine said at the press conference.
“Today we’ll be communicating information and advice to healthcare professionals on how to minimize risks. And this will provide a lot of guidance, including how to report any suspected cases.”