The UK Medicines Agency has stated that the benefits of Oxford / AstraZeneca’s vaccine continue to outweigh any risks, but added that an alternative boost will be offered to those under 30.
In a separate update on their investigations on Wednesday, the European Medicines Watchdog ruled that unusual blood clots are “very rare side effects” of the sting.
Some European countries have restricted the use of the vaccine in younger people after reports of cerebral venous sinus thrombosis (CVST), a type of blood clot that prevents blood from flowing out of the brain, and low platelet counts – cells that help blood clots.
Prime Minister Boris Johnson has said people should keep getting their pokes.
What did the regulators say?
A review by the European Medicines Agency (EMA) Safety Committee on Wednesday concluded that “unusual blood clots with low platelets should be listed as very rare side effects” of the AstraZeneca vaccine.
Emer Cooke, EMA General Manager, said, “These are very rare side effects.
“The mortality risk from Covid is much greater than the mortality risk from these side effects.”
The MHRA said the vaccine still had tremendous benefits in preventing Covid-19 and serious illnesses, but added that due to the very low number of blood clots in younger people, people under the age of 30 were offered Pfizer or Moderna shocks instead become.
Dr. June Raine, executive director of MHRA, issued a list of symptoms that should prompt the public to seek medical advice quickly.
She said of the briefing: “Anyone who has symptoms four days or more after vaccination should seek medical advice immediately if they have severe or persistent headache or blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, or even unusual bruises or spots on the skin beyond the injection site. “
How many people are affected?
As of March 31, the MHRA had received 79 reports of low platelet count blood clots, all in people who had received their first dose of vaccine.
Of these 79, a total of 19 people died, although the cause was not established in every case.
The 79 cases occurred in 51 women and 28 men aged 18 to 79 years.
The MHRA announced that three of the 19 deceased were younger than 30 years old. About 14 of these cases were CVST while the other five were thrombosis.
There have also been reports of CVST cases in Germany and cases of blood clot clusters in Norway, the Netherlands and Denmark, but experts say these incidents are rare.
How did other countries react?
Germany, France, the Netherlands, Sweden and Canada have restricted the use of the AstraZeneca vaccine in younger people, while Denmark and Norway have discontinued administration.
However, several European countries – such as Greece, Italy and Portugal – use the vaccine without such restrictions.
What did AstraZeneca say?
Last month, AstraZeneca analyzed its database to understand “whether these very rare cases of blood clots associated with thrombocytopenia (low blood platelet count) are more common than would naturally be expected in a population of millions of people”.
Meanwhile, a study of the Oxford / AstraZeneca vaccine in children was suspended on Tuesday, but the scientists involved said there were no safety concerns about the study itself and they are awaiting further information from the MHRA.
Oxford University said in a statement, “Although there are no safety concerns in the pediatric clinical trial, we are awaiting additional information from the MHRA on their review of rare cases of thrombosis / thrombocytopenia reported in adults before giving further vaccinations in the trial . “
What do the experts say?
Scientists in the UK largely agreed with regulators, saying the vaccine’s benefits outweigh the potential risks.
Professor Adam Finn of the University of Bristol and a member of the Joint Committee on Vaccination and Immunization (JCVI) said it was important to keep vaccines going while opening up society to prevent rising infection rates.
He urged people currently being offered the vaccine to take it, saying that the “risk / benefit ratio is very strong for receiving the vaccine”.
Professor Calum Semple, a member of the Scientific Advisory Group on Emergencies (Sage) advising ministers, said he was “not the least bit concerned” about the headlines surrounding the AstraZeneca vaccine.
In a personal capacity, he told LBC Radio: “I’ll take it myself, I’m 53 years old, my risk of death from Covid is around one in 13,000, for me it’s a no-brainer that I have to have the vaccine.” “
Meanwhile, former MHRA chief professor Sir Kent Woods told LBC Radio: “Covid itself – the infection itself – is known to be associated with a significantly increased risk of various types of blood clots.
“At a time when the population has a lot of Covid, it is very difficult to know what the real background rate of these clotting events is without the vaccine.
“We can say I think if there’s a connection it’s a very, very rare one.”
What other vaccines are there?
The UK is currently using two vaccines, Pfizer / BioNTech and Oxford / AstraZeneca, while a third coronavirus vaccine, the Moderna Jab, was launched in Wales on Wednesday.
Preliminary results announced Tuesday from trials of the Valneva Covid-19 vaccine, which is slated to be manufactured in the UK, showed that it elicited a “strong immune response” and paved the way for a phase 3 clinical trial paves.
The UK has an agreement in principle for 60 million cans of the Valneva sting with the option to purchase an additional 130 million cans from 2022 to 2025.
The country has also ordered 30 million doses of a coronavirus vaccine developed by Johnson & Johnson, which has been shown to be 66% effective at preventing coronavirus infection.
Both the Valneva and Johnson & Johnson jabs will require regulatory approval for use in the UK as soon as data from subsequent studies become available.