AstraZenica COVID Vaccine…What You Should Know, New Variants Replace Old One

In the UK up to 31 March, there were 79 reports of these rare blood clots with low platelets – some but not all of them in the brain, it was revealed on Wednesday. Of those affected, 19 people died, although it is not known if the blood clots were the cause in every case.

More were women – 51 – and they were all aged 18-79. Three were under 30. But the recommendation of an alternative vaccine for that age group is because their risk from Covid itself is very low.

In older age groups, the experts believe, the benefits of vaccination significantly outweigh the rare side-effect risk, but in younger people “it is more finely balanced”.

Dr June Raine, CEO of the Medicines and Healthcare products Regulatory Authority (MHRA), said the risk was “extremely small” and the authority had not yet concluded that the vaccine was responsible.

“The evidence is firming up. While it is a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused this side-effect,” she said.

“Today’s decision is a severe blow to the public’s vaccine confidence, which is already fragile,” said Dr Chris Papadopoulos, principal lecturer in public health at the University of Bedfordshire. It might be the right decision, but needed to be coupled to efforts to counter vaccine hesitancy, he added.

Prof Martin Hibberd, of the London School of Hygiene & Tropical Medicine, said it was a sensible decision. “However, I would like to see the evidence that the other vaccines are safer.”

The Royal College of Midwives said young people and pregnant women would be concerned.

“Although pregnant women who are clinically extremely vulnerable are eligible for the vaccine, those under 30 have seen their options severely limited, as the Pfizer/BioNTech vaccine is not approved for use for them,” said its executive director, Birte Harlev-Lam.

Pregnant women should discuss vaccination with their doctor. Those who have any history of blood clots should not have the AstraZeneca jab.

It came as the EMA said the rare blood clots would be listed formally as a side-effect of the AstraZeneca vaccine, though it did not announce any restrictions on use. Several EU countries, including France and Germany, have already limited use to citizens aged over 55 or 60, or suspended its use entirely.

Emer Cooke, executive director of the EMA, said: “In the UK, I cannot comment on the decision-making to restrict to a certain age but what I can tell you is there is a lot more use in the younger age groups in the UK than in the EU at the moment and we will certainly take this into account in our further evaluations.”

Asked why European countries have different stances from the UK, Adam Finn from the JCVI said Britain had “extremely detailed data” based on a high number of administered AstraZeneca jabs.

“I think other countries in Europe that have seen clusters of cases … they are not in such a good evidence-driven position to make their judgments,” he said, adding that “the risk-benefit [equation] does vary … from one country to another”.

The EMA said it could not identify the cause of the blood-clotting event, which was mostly, but not entirely, in women under 60.

It is advising that healthcare professionals and people getting the vaccine should be made aware of the issue and the symptoms of the clots, which range from shortness of breath and chest pain to persistent headaches and blurred vision.

“It is of great importance that healthcare professionals and people coming for vaccination are aware of these risks and look out for signs or symptoms,” said Cooke.

Like the EMA, the MHRA is a regulator and an adviser on safety and efficacy to governments.

The UK recommendation that under-30s should be offered an alternative vaccine comes from the JCVI. Its head, Prof Wei Shen Lim, said it had only made the recommendation to government “out of the utmost caution rather than because we have any serious safety concerns”.

Dr Peter Arlett, the head of the EMA data analytics and methods taskforce, said the agency was examining whether other vaccines posed any risk, citing cases of rare blood clots involving the Johnson & Johnson jab.

“There have been three cases with the Johnson & Johnson vaccine of blood clots associated with low platelets which have some similarities to these cases that we’ve been describing today,” he said.

“However, the numbers are extremely small compared with the 5 million patients that have received the Johnson & Johnson vaccine worldwide. This is, however, under close scrutiny, the [committee] is looking at it carefully, and I think it would be fair to say there’s intensive monitoring of this issue across the vaccines.”

A UK government spokesperson said: “The Oxford/AstraZeneca vaccine is safe, effective and has already saved thousands of lives.

“Everybody who has already had a first dose of the AstraZeneca vaccine should receive a second dose of the same brand, irrespective of age, except for the very small number of people who experienced blood clots with low platelet counts from their first vaccination.”

Concerns have been mounting over reports of rare but serious blood clots in a small number of recipients of the Oxford/AstraZeneca vaccine, leading to a UK recommendation on Wednesday that healthy adults under 30 should have an alternative jab if they can. We take a look at the latest information and guidance.

What are the potential side-effects from Covid vaccines?

All medications including vaccines have some side-effects. The most common with the Covid jabs are mild and short-lived, including localised soreness, fatigue or aches and headaches.

However the Oxford/AstraZeneca jab has been linked to a small but concerning number of reports of blood clots combined with low platelet counts (platelets are cell fragments in our blood that help it to clot).

These include a rare clot in the brain called cerebral venous sinus thrombosis (CVST). In an unvaccinated population, upper estimates suggest there may be 15 to 16 cases per million people per year. But also highly uncommon is the combination of CVST or other rare clots with low platelets, and sometimes unusual antibodies – and that combination is at the centre of current concerns.

The Medicines and Healthcare products Regulatory Agency (MHRA) said recipients of the Oxford/AstraZeneca jab should look out for new headaches, blurred vision, confusion or seizures that occur four days or more after vaccination.

While headaches are very common post-vaccine, Dr Josh Wright, vice-president of the British Society for Haematology, stressed that those linked to CVST are unusually severe and persistent and progressively worsen over a period of days. Most cases are reported within two weeks of someone having the jab.

The MHRA also flagged shortness of breath, chest pain, abdominal pain, leg swelling and unusual skin bruising as reasons to seek medical advice.

Once identified, the symptoms can be treated. Beverley Hunt, professor of thrombosis and haemostasis at King’s College London and a representative of Thrombosis UK, said the first step would be to give a dose of intravenous gamma globulin – essentially giving concentrated antibodies which block the effect of the antibodies that could be causing the clotting problems. Once the patient is stable this is then followed by giving them anticoagulation agents, but not heparins.

How many cases have there been?

Up to and including 31 March, the MHRA said it received 79 reports of cases of blood clots combined with low platelets, including 19 deaths, following more than 20m doses of the Oxford/AstraZeneca jab. That equates to about four cases for every million vaccinated individuals.

The MHRA added that 44 of the reports and 14 of the deaths related to CVST with a low platelet count. Of the 19 deaths, 11 were in people under the age of 50 and three were in people under the age of 30.

Two cases of blood clots with a low platelet count have also been reported among recipients of the Pfizer/BioNTech jab. “This is a particularly rare and very unique form of abnormal clotting,” said Wright.

The European Medicines Agency is also examining three cases of venous thromboembolism blood clots involving the Johnson & Johnson jab.

The MHRA says blood clots combined with low platelets can occur naturally in unvaccinated people as well as in those who have caught Covid, and that while evidence of a link with the Oxford/AstraZeneca vaccine has become stronger, more research is needed.

How may the vaccine cause these problems?

At present the mechanism by which the jab could cause clotting problems remains unclear. But experts have noticed a similarity to a clotting event sometimes seen among people given the blood-thinning drug heparin, whereby antibodies are generated that result in platelets becoming activated.

“In very rare situations heparin can actually cause this platelet activation problem and lead to blood clots in unusual places. So there are some similarities between these two conditions,” said Wright.

According to Hunt, one possibility is that the Oxford/AstraZeneca vaccine may also trigger the production of antibodies that activate platelets, causing them to form clots. In the process, platelets are used up, resulting in a fall in the platelet count.

What is the current official recommendation?

The MHRA, along with the EMA and the World Health Organization (WHO), have all repeatedly said people should continue taking the Oxford/AstraZeneca shot because its benefits in preventing Covid infection far outweigh any risks.

However on Wednesday the MHRA acknowledged a possible link between the jab and the clots, adding that careful consideration should be given to those who may be at higher risk of certain types of blood clots.

In addition, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) said it was recommending that people aged 18-29 should be offered other Covid vaccines – if available – provided they are healthy and at low risk of Covid. There are about 10 million 18- to 29-year-olds in the UK.

“Although the chance of any person receiving the vaccine experiencing a blood clot with low platelets is extremely small, because the risk of severe Covid in the under-30s with no underlying illness is also small, JCVI feel as a precautionary measure it is appropriate for those in this age group to be offered an alternative Covid vaccine when their turn comes for their first dose of a vaccine,” said Prof Anthony Harnden, deputy chair of the JCVI.

Pregnant women should discuss with their doctors whether to have the Oxford/AstraZeneca jab as pregnancy can increase the risk of blood clots, the MHRA said.

Meanwhile on Wednesday the EMA said the rare clotting syndrome should be listed as a very rare side-effect of the Oxford/AstraZeneca jab after reviewing 62 cases of CVST and 24 cases of splanchnic vein thrombosis, largely from Europe and the UK where 25m doses of the jab have been given. Of these cases, 18 were fatal.

“So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination,” the EMA said, although specific risk factors have not yet been confirmed.

According to data from the MHRA, 51 of the 79 clotting cases and 13 of the deaths were in women, although women were more likely to receive the Oxford/AstraZeneca jab than men.

Should people take aspirin after the vaccine?

There has been no advice that anyone should take medication to prevent rare clotting events. Hunt cautioned against taking aspirin, stressing it is thought the clotting problems are down to an immune response.

“So taking aspirin is not going to be helpful. Taking an anticoagulant probably isn’t going to be helpful, especially if you are going to get a low platelet count, it will increase your risk of bleeding,” she said. “And we know if you take aspirin and you don’t need to take aspirin the benefits aren’t very good and there is a risk that you can bleed spontaneously.”

Does the contraceptive pill increase women’s risk of blood clots more than the Oxford/AstraZeneca jab?

Combined hormonal contraceptives, which contain oestrogen, have been associated with an increased risk of blood clots including CVST, deep vein thrombosis and pulmonary embolism.

According to an EMA review in 2014, the risk of blood clots ranged from five to 12 cases per 10,000 women who take combined hormonal contraceptives for a year, compared with two cases each year per 10,000 women who are not using such contraceptives. “The combined oral contraceptive pill is probably the commonest cause of cerebral sinus thrombosis, so it is a very good comparison,” said Hunt.

Adam Finn, professor of paediatrics at the University of Bristol and a member of the JCVI, said other risk-benefit comparisons can also be made. “We’ve seen data that the annual risk of dying in a car crash if you regularly travel in a car is about 1 in 20,000, with a lifetime risk of about 1 in 240,” he said. “We take those risks for granted.” The faculty for sexual and reproductive health stressed the risk of blood clots from the pill was also low – much smaller than the risk of having a blood clot if they were pregnant.

Should you have a second dose of the Oxford/AstraZeneca jab?

The vast majority of people who had a first dose of the jab, including under-30s, should get their second dose, with some exceptions.

“Anyone who experienced cerebral or other major blood clots occurring with low levels of platelets after their first vaccine dose of Covid-19 Vaccine AstraZeneca should not have their second dose,” the MHRA said. “Anyone who did not have these side-effects should come forward for their second dose when invited.”

All 79 cases detailed by the MHRA occurred after the first dose, but that could be because far more people have received their first dose than their second.

Could other Covid vaccines cause these clotting problems?

Harnden said at present this is unclear. “Because we don’t know what the causal mechanism is yet – and although there is a strong possibility that this is caused by the Oxford/AstraZeneca jab, we are not 100% certain – we can’t really postulate [about] other [vaccine] types at the moment,” he said.

But the occurrence of only two cases of blood clots and low platelets among those vaccinated with the Pfizer jab suggests the problem is linked to the Oxford/AstraZeneca jab, he said.

One possibility is that it is linked to the type of vaccine, with the EMA examining whether other vaccines using similar technology to the Oxford/AstraZeneca vaccine posed any risk.

The Janssen (Johnson & Johnson) vaccine also uses a modified cold virus to introduce the instructions for the spike protein into our cells – but whereas the Oxford/AstraZeneca vaccine uses a chimp adenovirus, the Johnson & Johnson vaccine uses a human cold virus.

Dr Peter Arlett, head of data analytics and methods taskforce, said so far there had been three cases of venous thromboembolism blood clots involving the Johnson & Johnson jab.

“However the numbers are extremely small compared to the 5 million patients that have received the Johnson & Johnson vaccine worldwide. This is, however, under close scrutiny, the [committee] is looking at it carefully, and I think it would be fair to say there’s intensive monitoring of this issue across the vaccine.

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(CNN) Canadian public health officials say a rapidly spreading variant likely has now replaced the original Covid-19 virus in many parts of the country, and new variants are making younger people sicker and sending more to the hospital.

“This isn’t the news any of us wanted, but hospitalizations are surging, ICU beds are filling up, variants are spreading and even people who had convinced themselves they didn’t need to be concerned are getting sick,” Canadian Prime Minister Justin Trudeau said at a news conference Tuesday, adding this is a “very serious” third wave of the pandemic.

Trudeau made a pointed appeal to young people, urging them to “stay home” as younger Canadians are getting sicker in this third wave.

Intensive care unit admissions are up 18% in the past week alone, and the new variants are placing a “heavy strain” on hospital capacity, the Public Health Agency of Canada said.

Coronavirus and travel: Everything you need to know

Coronavirus and travel: Everything you need to know

“With increasing rates of infection, we are seeing a greater number of younger adults with Covid-19 being treated in hospital,” said Dr. Theresa Tam, Canada’s chief public health officer. She added that more than 15,000 variant cases have been detected so far, the vast majority of them the B.1.1.7 variant first detected in the United Kingdom.

In many provinces now experiencing a third wave, chief public health officers are reporting that younger patients are getting severely ill with Covid-19, and many of those cases have tested positive for variants of concern, according to Tam.

“Many of them deteriorate quite quickly and have to be admitted to the ICU quite immediately, and then they spend quite a bit length of time staying in the ICU, which means that there’s a capacity impact as well,” Tam said.

While hospitalizations haven’t increased dramatically, more of the patients admitted are now needing critical care as variants are making them more severely ill, she said.

In Toronto, public health officials ordered all elementary and secondary schools to stop in-person learning and shift to remote learning, effective Wednesday, as they try to “reverse the surge of infection that the province currently faces,” Toronto Public Health said.

Biden ramps up vaccine diplomacy efforts as hopes rise that he'll share surplus doses

Biden ramps up vaccine diplomacy efforts as hopes rise that he’ll share surplus doses

Ontario, whose capital is Toronto, is debating new and more restrictive measures, including a stay-at-home order, as its ICU capacity is increasingly strained.

The order will be in place from April 7-18, according to the guidance issued Tuesday, and may be extended.

“Current circumstances require that difficult decisions must be taken locally to protect all those in our school communities, including students, teachers and staff,” Toronto Public Health said.

British Columbia has moved to close the Whistler ski resort and further restrict gatherings in the province, which is now also coping with an outbreak of the virus among NHL hockey players with the Vancouver Canucks.

California says it will fully reopen in June, citing falling Covid-19 case rates

California says it will fully reopen in June, citing falling Covid-19 case rates

The province of Alberta also confirmed it was dealing with new clusters of cases involving the P.1 variant.

This week, Canada surpassed 1 million Covid-19 cases since the pandemic began. Tam called that milestone a “stark reminder” of everything Canadians have been through.

While the B.1.1.7 variant has now likely become the dominant variant in Canada, Tam said her team is also keeping a close eye on a significant outbreak of the P.1 variant, first detected in Brazil and now surging in some western Canadian provinces.

Monday, British Columbia’s health minister said the number of cases of the P.1 variant in his province almost doubled over the Easter holiday weekend.

“The most transmissive variants of Covid-19 are ultimately going to take over,” Adrian Dix said in a Monday update.

CNN’s Elizabeth Stuart and Theresa Waldrop contributed to this report.