Investigations into possible rare, serious vaccine side effects are not worrying – they’re reassuring

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, prepares to receive his first dose of a COVID-19 vaccine at the National Institutes of Health on December 22, 2020 in Bethesda, Maryland.

  • The European regulator this week declared the AstraZeneca-Oxford University vaccine safe.
  • But it will keep investigating reports of rare clots after vaccination, particularly among younger women.
  • These investigations into side effects shouldn’t worry us – they’re a sign monitoring is working.
  • See more stories on Insider’s business page.

All effective medicines have side effects. We put up with them because, overall, the medicines make us feel better, or prevent something far worse.

The same principle applies to COVID-19 vaccines.

The benefits of AstraZeneca’s shot in preventing COVID-19 – which has killed 2.6 million people worldwide – outweighs the risk of any side effects, the European medicines regulator said Thursday. Its statement followed a thorough investigation into reports of rare and serious blood clots in vaccinated people.

The European Medicines Agency (EMA) said it found no increased risk of blood clots overall with AstraZeneca’s vaccine. But it couldn’t rule out a link between the vaccine and very rare, serious blood clots in the brain, or a clotting disorder called disseminated intravascular coagulation (DIC), particularly in women under 55 years old.

The EMA still recommended that people in this demographic take the shot because the risk of these blood disorders was “extremely small.”

Despite the recommendation, France announced Friday that it would not give people under 55 AstraZeneca’s vaccine.

Ian Douglas, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, told Insider that the EMA’s announcement was not worrying, but “reassuring.”

It not only showed that potential side effects were being monitored closely, but that regulators were being upfront with the public, he said.

“For these reports to happen, there needs to be a suspicion of a link. But everytime we hear it, it won’t mean that it has been caused by the vaccine necessarily,” he said.

“It would be worse if all this was being done in secret, and something got out.”

Lots we still don’t know about the rare blood clots

There are lots of details that we don’t yet know about the 25 reported cases of serious clots: 18 in the brain, seven elsewhere in the body, related with DIC.

It’s possible that these people were at increased risk of blood clots anyway. For example, they may have had underlying illnesses linked to clots, including COVID-19, or an inherited blood disorder. Smoking, the combined oral contraceptive pill, and hormone replacement therapy are all common reasons a woman under 55 may have an increased blood-clot risk.

The EMA also said that a greater number of women under 55 may have been immunized with AstraZeneca’s vaccine, due to targeted vaccine campaigns in different EU countries.

The EMA has updated the AstraZeneca vaccine’s leaflet for patients and healthcare professionals to include signs and symptoms of clotting, so people know when to seek help. A severe or worsening headache or blurred vision after immunization requires prompt medical attention, for example, whereas a mild headache doesn’t.

Regulators may well establish more potential links between serious illness and other COVID-19 vaccines over the next few months, and issue more guidance. This shouldn’t cause alarm: it’s simply a sign that the monitoring system works.

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There’s no evidence yet that AstraZeneca’s vaccine causes blood clots, and experts say any risks are outweighed by the shot’s benefits

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A vaccinator administers an injection of AstraZeneca/Oxford Covid-19 vaccine to a patient at a vaccination centre in Chester, northwest England, on February 15, 2021.

  • Denmark and Norway suspended the use of AstraZeneca’s COVID-19 shot Thursday as a “precautionary measure”.
  • The Danish Health authorities cited concerns about blood clots in people that had received the shot.
  • Data suggests that the risk of clots is no greater than in the population at large.
  • See more stories on Insider’s business page.

Denmark, Norway, and Iceland suspended their roll out of AstraZeneca and the University of Oxford’s COVID-19 vaccine as a “precautionary” step Thursday, citing concerns about blood clots in people who had received the shot.

One person in Denmark who was immunized with the vaccine died from a blood clot, the Danish Health Authority said in a statement Thursday. At this point, it’s not known whether there is a link between the vaccine and blood clots, it said.

This follows Austrian authorities saying Sunday that a 49-year-old woman had died as a result of severe coagulation disorders after taking the shot.

The Danish Health authorities said officials “have to react” to reports of possible serious side effects, although there was “good evidence” that the vaccine was both safe and effective.

The European Medicines Agency (EMA) OK’d the shot on January 29, having looked extensively at all its safety and efficacy data, but individual countries can ultimately decide whether they give it to their citizens.

AstraZeneca vaccine and blood clots: the stats so far

There have been a total of four reported cases in Europe of people getting vaccinated with a specific batch of AstraZeneca’s shot and then developing blood clots afterwards, according to the EMA. The batch of 1 million doses had been sent to 17 EU countries, including Denmark.

At least five countries – Austria, Estonia, Lithuania, Luxembourg, and Latvia – have suspended the use of this particular batch. Norway, Denmark, and Iceland suspended the vaccine completely.

The EMA said Wednesday that one person in Europe had been diagnosed with multiple blood clots in vessels 10 days after vaccination. It was unclear whether this was the Danish case, although by that time Austrian authorities had already reported a death.

Insider contacted the Danish health authority for clarification, and a spokesperson said that they were “not at liberty to inform on the data that we receive from other authorities, national or international.”

Another person in Europe was hospitalized with a blood clot in the lung after being vaccinated, who was “now recovering,” the EMA said.

The time-frame between getting the vaccine and developing the clot for this person was not documented.

There were two other reports of blood clots, the EMA said. No further details were provided such as age, or whether they had medical conditions that made their blood more likely to clot.

No more blood clots than in general population

The EMA said in a press release that overall, as of Thursday, there had been 30 cases amongst more than 5 million who had been vaccinated with AstraZeneca’s shot overall. There was no indication that the vaccine caused blood clots, and this wasn’t a known side effect, they said.

Professor Jon Gibbons, director of the Institute of Cardiovascular and Metabolic Research at the University of Reading, said in a statement that blood clots in the general population were relatively common, and affected an average of between one and two people per 1,000 – a higher proportion than 30 in 5 million.

“Therefore if there is any association between the vaccine and clotting, the risk is likely to be very low indeed,” he said.

Dr. Phil Bryan, the Medicines and Healthcare Products Regulatory Agency (MHRA) safety lead, said in a statement that the number of reports of blood clots received so far in the UK – where more than 11 million doses of AstraZeneca’s vaccine have been given – were not greater than what would have occurred usually in a population that size.

The UK did not receive the batch from which the four most recent reports of clots arose.

Denmark’s approach ‘super’ cautious

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a statement that the Danish approach was “super” cautious.

“Since we know with great certainty that the vaccine prevents COVID-19, and we are almost totally uncertain that the vaccine can have caused this problem, the risk and benefit balance is still very much in favour of the vaccine in my view,” he said.

Evans said that it was difficult to distinguish between coincidence and the vaccine’s side effects.

“This is especially true when we know that COVID-19 disease is very strongly associated with blood clotting and there have been hundreds if not many thousands of deaths caused by blood clotting as a result of COVID-19 disease,” he said.

Professor Anthony Harnden, Deputy Chair of the Joint Committee on Vaccination and Immunisation – the organization that advises the UK’s vaccine strategy – said in a statement that the public should have “confidence” that AstraZeneca’s vaccine was “safe and highly effective at preventing severe disease, including the prevention of blood clots caused by COVID-19.”

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Pakistan approves AstraZeneca’s COVID-19 vaccine for emergency use

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A man and child with protective masks walk outside a market as the coronavirus disease pandemic continues, in Karachi, Pakistan,

Pakistan on Saturday approved the coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, according to multiple reports. 

Asad Umar, a government official working on the vaccine rollout, said the vaccine will first be given to people older than 65 and healthcare workers, according to The Associated Press.  

Speaking on Saturday, Umar said provinces and the private sector were free to import the drug, subject to the approval of the Drug Regulatory Authority of Pakistan (DRAP), according to Dawn, a local newspaper. 

Read more: What’s coming next for COVID-19 vaccines? Here’s the latest on 11 leading programs.

“From day 1, the [National Command and Operation Centre] has adopted the policy that the federal government shall not have the monopoly to import anti-coronavirus vaccines,” said Umar, according to Dawn.

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AstraZeneca’s COVID-19 vaccine.

Pakistan late last year signed an agreement with China’s National Pharmaceutical Group, known as Sinopharm, for more than a million doses of its vaccine, according to The Express Tribune. Sinopharm’s drug has not yet been approved by DRAP. 

The country may also import “tens of millions” of doses of a vaccine made by China’s CanSinoBio, Faisal Sultan, special assistant to the prime minister on national health services, told the newspaper

Pakistan has had 519,291 confirmed COVID-19 cases, with 10,951 deaths, according to data compiled by Johns Hopkins University.

In the last week, about 307 people died following COVID-19 infections, down from the country’s record high of 861 weekly deaths in mid-June, according to Johns Hopkins. 

A second wave of coronavirus cases hit Pakistan in November and December, according to data shared on Twitter by Umar earlier this month. 

Umar urged people in Pakistan to follow safety regulations in an effort to flatten the curve. 

Last week, he said: “Data clearly shows that covid health consequences are strongly correlated with our decisions & personal choices. Hence it’s important that we all take responsibility & take precautions. If we do the right things we shall inshallah continue to safeguard lives & livelihoods.” 

Neighboring India began the world’s largest vaccination drive on Saturday, with the goal of inoculating 300,000 people in one day. India approved AstraZeneca’s vaccine, which goes under the name Covishield in the country, for emergency use in early January.

 

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AstraZeneca’s stock jumps after the UK authorizes emergency use of its vaccine, which it created with Oxford University

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Oxford University and AstraZeneca’s vaccine has two names – ChAdOx1 nCoV-19 and AZD122

  • AstraZeneca’s stock rose on Wednesday after the UK authorized the vaccine it created with Oxford University.
  • It is the second vaccine authorized for emergency use in the UK, after Pfizer and BioNTech’s.
  • AstraZeneca’s vaccine is easy to store and requires standard refrigeration. Other COVID-19 shots need cold storage. 
  • One chief market strategist said these less cumbersome logistical needs could help the vaccine end further UK restrictions.
  • Visit Business Insider’s homepage for more stories.

AstraZeneca’s stock jumped on Wednesday after Britain authorized emergency use of the COVID-19 vaccine it developed with Oxford University. 

The pharma group was among the FTSE 100’s leaders as its shares jumped 0.7% in early European trading. Its shares were up about 3.3% at the start of trade.

The vaccine should be available early in 2021, AstraZeneca said.

Britain’s approval is “certainly good news because there is no doubt that the current coronavirus vaccine demand is nowhere close enough to supply,” said Naeem Aslam, chief market analyst at AvaTrade. 

The approval should improve the coronavirus situation in the UK, where COVID-19 cases continue to surge, and much of the country is in lockdown, he said.

Read More: Jason Teed has beaten 99% of his investor peers this year. He breaks down how his Morningstar gold-rated fund did it with a trend-following strategy, and shares his advice for navigating the stock market in 2021.

A new variant of the coronavirus that appears to be more easily transmissible has been blamed for the wave of new cases. The country registered a record high of 53,135 new cases and 414 fatalities on Tuesday, bringing the seven-day case count to more than 272,000. 

AstraZeneca’s vaccine is the second to be approved in the UK, after Pfizer and BioNTech’s. More than 600,000 people in the country have already been vaccinated with the first dose of the two-dose Pfizer shot. 

Read More: Bank of America highlights its top 8 stock picks in the booming housing sector – including one it expects to rally 54% next year

Several parts of England went into the highest tier of coronavirus restrictions on December 20. People in these areas have been advised to stay at home.

AstraZeneca’s vaccine can be stored in a standard refrigerator – the other COVID-19 vaccines require cold storage.

Its rollout could stop further restrictions in the UK, given its less cumbersome logistical and storage requirements, according to Stephen Innes, chief global market strategist at Axi. 

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AstraZeneca will work with the makers of Russia’s Sputnik V vaccine to test a combined shot. This could make people more immune, and for a longer period of time, it said.

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A photo illustration show a syringe. Argentina was selected to test a vaccine against COVID-19, it is estimated that the clinical phases will begin in August.

  • The COVID-19 vaccine being developed by AstraZeneca and the University of Oxford will be combined with Russia’s Sputnik V shot, which the country has already authorized for emergency use.
  • In a press release on Friday, AstraZeneca said that it would “soon begin exploring” combining its shot with one made by Russia’s Gamaleya Research Institute, which developed Sputnik V. 
  • It did not specifically say that it was combining its vaccine with the Russian shot — but Russia’s sovereign wealth fund, which is financing the country’s vaccine development, confirmed the vaccine in question is one of two vectors that make up Sputnik V.
  • Trials will start by the end of 2020, the wealth fund said.
  • Combining two different vaccines could improve their accessibility as well as providing better protection against COVID-19, AstraZeneca said.
  • Visit Business Insider’s homepage for more stories.

AstraZeneca, the British drugmaker working with the University of Oxford to develop a COVID-19 vaccine, plans to work with the developers of Russia’s Sputnik V to explore a combined shot, it said.

AstraZeneca “will soon begin exploring with Gamaleya Research Institute in Russia to understand whether two adenovirus-based vaccines can be successfully combined,” the drugmaker said in a statement Friday, naming the developer of the Sputnik V vaccine, but not the specific shot.

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, confirmed the vaccine in question was one of two vectors that make up Sputnik V.

Clinical trials are slated to begin by the end of December, the RDIF, which is financing the development of Sputnik V, added.

This is the second time AstraZeneca’s vaccine is being used in a “mix and match” trial. On Tuesday, the head of the UK’s vaccine taskforce said it would combine the shot with Pfizer’s vaccine to see if the two vaccines together produce a stronger immune response.

Combining different COVID-19 vaccines “may be helpful to improved protection and/or to improve vaccine accessibility,” AstraZeneca said Friday, adding that it “is also likely that combining vaccines may lead to improved immunity over a longer-period of time.”

The RDIF welcomed the cooperation between vaccine producers, its CEO Kirill Dmitriev said Friday, and said it hoped other vaccine producers will follow the example. The RDIF and the Gamaleya Institute approached AstraZeneca in November to suggest combining vaccines.

“The decision by AstraZeneca to carry out clinical trials using one of two vectors of Sputnik V in order to increase its own vaccine’s efficacy is an important step towards uniting efforts in the fight against the pandemic,” Dmitriev added.

Read more: Pharmacies, doctor’s offices, and hospitals are gearing up to give coronavirus vaccines to millions of Americans. Here’s how they’re preparing and how much they stand to profit along the way.

AstraZeneca’s vaccine has not been authorized for use anywhere in the world. In November, AstraZeneca said it would retest its vaccine after admitting that the most positive results in its first trial came from a dosing error.

Russia gave Sputnik V emergency-use authorization on August 11, making it the world’s first vaccine to be approved. The country has been giving it to frontline healthcare workers, though it hasn’t started mass vaccination yet because it’s still in trial stages.

Russia says the vaccine is more than 90% effective.

Why are drugmakers combining different vaccines?

Vaccines often require multiple doses. Pfizer, Moderna, and AstraZeneca’s vaccines each require two shots given two to four weeks apart. The first dose is an initial prime, followed by a boost.

“Homologous boosting” is when all shots are the same vaccine, but what AstraZeneca is testing is “heterologous boosting,” where two different vaccines are given.

“It is … likely that combining vaccines may lead to improved immunity over a longer-period of time,” AstraZeneca said in its statement.

The practice could also improve vaccine accessibility, it said, by making immunization programs more flexible.

Sputnik V itself uses two different adenoviral vectors for its two shots, which it says produces a stronger and longer-term immune response.

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