AstraZeneca jab benefits ‘outweigh risks’ but under-30s offered alternative

Dr June Raine, head of the Medicines and Healthcare products Regulatory Agency, told a press conference: "Our review has reinforced that the risk of this rare suspected side effect remains extremely small.”

Dr Raine was speaking at a briefing hosted by England’s deputy chief medical officer Professor Jonathan Van-Tam following an investigation into the Oxford/AstraZeneca vaccine and potential links with blood clots.

The briefing came after the European Medicines Agency (EMA) gave an update saying AstraZeneca has "proven to be highly effective – it prevents severe disease and hospitalisation, and it is saving lives".

Prof Jonathan Van-Tam began his briefing by saying the UK's vaccination programme has been "a most enormous success" but there is now the need for a "course correction".

He told a press conference: “The UK vaccine programme has been the most enormous success indeed.

“If you had said to me that by March 2021 we would not have needed a course correction, that also would have amazed me.”

Dr Raine, from the UK's medicines regulator, said more than 20 million doses of the AstraZeneca vaccine have been given in the UK and the jab is the best way to protect people from Covid-19 - but no effective vaccine is without risk.

She said the safety monitoring systems were detecting “a potential side effect of the Covid-19 vaccine AstraZeneca in an extremely small number of people”.

“The evidence is firming up and our review has concluded that, while it’s a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused these side effects.” 

She added:  “Based on the current evidence, the benefits of the Covid-19 vaccine AstraZeneca against Covid-19 and its associated risks – hospitalisation 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.”

Dr Raine said three under-30s were among the 19 who had died after a rare blood clot following the Oxford/AstraZeneca vaccine.

She told the briefing: “By March 31, over 20 million doses having been given, we’ve had 79 case reports up to and including that date.

“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 aged 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 receive the vaccine.

“Three out of the 19 were under 30 years.”

Dr Raine gave a list of symptoms that should prompt the public to come forward for swift medical advice.

She told the briefing: “Anyone who has symptoms four days after vaccination or more should seek prompt medical advice, a new onset of a severe or persistent headache or blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain or indeed unusual skin bruising or pin-point spots beyond the injection site.”

Professor Wei Shen, chairman of the Joint Committee on Vaccination and Immunisation said the recommendation to prefer other vaccines to AstraZeneca for the under-30s was “out of the utmost caution” rather than because of “any serious safety concerns”.

Prof Van-Tam went on to acknowledge the change in recommended use of the AstraZeneca vaccine might result in delays and longer journeys to receive the jab.

He told a press conference: “The NHS has a message that we will get the right vaccine to you in the right time according to the new JCVI advice.

“There might be a small delay sometimes, there might be a slightly greater distance that some people might be asked to travel.

“But the NHS is all over this and understands the challenge of making the advice from JCVI truly operational in a smooth way.”

Prof Van-Tam used a nautical analogy to describe the “course correction” in the vaccination programme.

He said it was “quite normal” and “business as usual” for medics to alter their preferences on how to treat patients.

“This is a massive beast that we are driving along at enormous pace with enormous success, this vaccine programme,” he said.

“If you sail a massive liner across the Atlantic then it’s not really reasonable that you aren’t going to have to make at least one course correction during that voyage.”

The EMA and the MHRA have both carried out reviews into reports of rare brain clots in people who have had the AstraZeneca vaccine.

A review by the European Medicines Agency’s safety committee has concluded that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the Oxford/AstraZeneca vaccine.

The benefits of the Oxford/AstraZeneca vaccine continue to outweigh any risks for most people, the UK medicines watchdog has said, as European regulators ruled that unusual blood clots were “very rare side effects” of the jab.

Executive director Emer Cooke told a Brussels press briefing: “First of all, I want to start by stating that our safety committee, the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency, has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects.

“Covid-19 is a very serious disease with high hospitalisation and death rates and everyday Covid is still causing thousands of deaths across the EU.

“This vaccine has proven to be highly effective – it prevents severe disease and hospitalisation, and it is saving lives.

“Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.

“The PRAC, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said there were still huge benefits of the vaccine in preventing Covid-19 and serious disease.

However, due to a very small number of blood clots in younger people, those under the age of 30 will be offered Pfizer or Moderna instead.

The European Medicines Agency (EMA) said most of the cases of blood clots reported have occurred in women under 60 within two weeks of vaccination with the AstraZeneca jab, but that no specific risk factors had been identified based on current evidence.

Following a review of all available evidence, its Pharmacovigilance Risk Assessment Committee said the blood clots reported had been found in veins in the brain, the abdomen and arteries, combined with low levels of blood platelets and sometimes bleeding.

The EMA said symptoms associated with the blood clots include shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin beyond the area where the injection wad administered, and anyone who displayed them should seek medical attention.

The committee carried out an in-depth review of 62 cases of clots in the brain and 24 cases of clots in the abdomen as of March 22, with 18 of the combines cases proving fatal.

They came from reporting systems in the European Economic Area and the UK, from around 25 million people who had received the vaccine.

The European Medicines Agency reiterated that the AstraZeneca vaccine had been “proven to be highly effective” and that vaccination as a whole is “extremely important” in the fight against Covid-19.

Executive director Emer Cooke told a Brussels press briefing: “First of all, I want to start by stating that our safety committee, the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency, has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects.

“Covid-19 is a very serious disease with high hospitalisation and death rates and everyday Covid is still causing thousands of deaths across the EU.

“This vaccine has proven to be highly effective – it prevents severe disease and hospitalisation, and it is saving lives.

“Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.

“The PRAC, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”

Emer Cooke, executive director of the European Medicines Agency, sought to downplay any concerns about blood clots.

She said: “These are very rare side effects.

“The risk of mortality from Covid is much greater than risk of mortality from these side effects.”

Dr Sabine Straus, the regulator’s chairwoman, said the available data found a “very rare event that might occur”.

She told a press conference: “The frequency is difficult to assess, but we feel if you state the reporting rate is approximately one in 100,000 or even a little bit higher, that would reflect the risk.

“Based on that information we ask national vaccination authorities to make up their mind on who they would like to vaccinate with which kind of vaccine.”

A plausible explanation for rare blood clotting side effects from the AstraZeneca vaccine could be an immune response similar to conditions seen in patients treated with the anticoagulant – commonly known as blood thinner – heparin, the European Medicines Agency (EMA) said.

Dr Sabine Straus, EMA safety committee chairwoman Dr Sabine Straus, said: “Current available data did not allow us to identify a definite cause for these complications.

“However possible plausible explanations have been put forward, including an immune response that leads to a condition that seems similar to atypical to heparin-induced thrombocytopenia.”

Prime Minister Boris Johnson said he will carefully follow the advice on the Oxford/AstraZeneca vaccine from the MHRA and JCVI but does not believe he will have to alter the schedule for easing the lockdown.

During a visit to Cornwall, he told broadcasters: “I think the crucial thing on this is to listen to what the scientists, and the doctors, the medical experts, have to say.

“The MHRA is meeting, the JCVI is meeting, they’ll be setting out the position and we will get on with rolling out the vaccine and obviously we’ll follow very carefully what they have to say.

“I don’t think anything that I have seen leads me to suppose that we will have to change the road map or deviate from the road map in any way.”