After a week-long confusion in Europe over the safety of the Oxford/AstraZeneca Covid-19 vaccine, Oxford immunologist-vaccinologist Dr. Ahmed Salman spoke to Majalla about the scientific and statistical data which was submitted to European and international regulators to prove the safety and efficacy of the jab.
“The Oxford/AstraZeneca vaccine is authorized in more than 142 countries, with 70 countries using it already,” Dr. Salman, a member of Oxford’s Jenner Institute research group working on the Covid-19 vaccine, told Majalla.
The vaccine has been administered to approximately 100 million people all over the world, sometimes under the name of Covishield. In the EU, almost 17 million people received the jab, out of whom only 37 cases reported blood clots or thrombosis.
Dr. Salman remarked, “All statistics and scientific data indicate that normally every year a thousand out of each one million people, with or without medical history, suffer blood clots. Accordingly, every day three in every million people show symptoms of blood clots. This means 51 cases out of 17 million in normal conditions.”
“Thus, 37 cases in 17 million is just coincidence,” he added. “In England between 12 to 13 million people were inoculated. None of them showed any signs of thrombosis or severe adverse effects. All our scientific and official data prove that the vaccine is safe and effective with no serious side effects or death cases,” he confirmed.
He explained that the decision by health authorities to temporarily the vaccine can be considered as precautionary measures to make sure that this is coincidence and not linked with the inoculation.
On Thursday, March 18, the European Medicines Agency (EMA) has finally announced its support for continuing the AstraZeneca vaccination process after reviewing the most recent scientific and statistical data. The revision was conducted following a decision taken earlier this week by more than a dozen European countries to temporarily suspend the use of AstraZeneca vaccine due to some reports of unusual blood clots in some people who took the jab.
The European regulator’s safety committee announced in a "clear scientific conclusion" that the inoculation’s benefits “outweigh” the risks. Emer Cooke, the executive director of the EMA, said in a press briefing that the AstraZeneca vaccine is a "safe and effective option to protect citizens from Covid-19,” although she remarked that the EMA could not "definitively rule out a link" between the vaccine and blood clots.
She also added that agency will continue to study possible links between rare blood clots and the vaccine.
After the regulator’s announcement, France, Germany, Italy, the Netherlands, Portugal, Spain and several other European countries are set to resume the inoculation with AstraZeneca.
The AstraZenera inoculation pause is similar to another temporary suspension - that of the Pfizer vaccine which took place in mid-January in Norway. Twenty-three elderly patients died after receiving Pfizer jabs in a care center. The vaccination process was halted for two or three days, to conduct a probe and review data, then the inoculation resumed after announcing that the incident is not related to the vaccine.
Dr Salman emphasized that “Vaccines are usually given to elderly people in their 70s, 80s or 90s. Of course, this category naturally has higher risk of blood clots. But it was coincidence. As scientifically evident, the vaccine is completely safe and effective.”
OTHER ADVERSE EFFECTS
Asked about how any other side effects are detected, the Oxford immunologist described the current inoculation processes as the fourth stage tests, in which “any person who receive the vaccine and shows any kind of symptoms can record them. We collect periodical statistics, and research papers are published about all types of vaccines.”
“We are now witnessing what is called emergency use authorization of vaccines, where the vaccine work should be followed up for a year or two, until we can definitively confirm the expected adverse effects, even in very low rates, 1 in a million or 1 in 10 million cases,” he explained.
He also made clear that symptoms tracked so far are acceptable and don’t have long term impact, such as rise in temperature, or swelling of the injection site, or the feeling of mild cold for a day or two at most. “In the worst case scenario, the patient may need to take paracetamol, which is definitely acceptable,” he said.
CONCERNS COULD LINGER
There is no denying though, that European countries’ decision to halt the AstraZeneca immunization process would have negative impact on the people’s confidence in the vaccine and may affect their readiness to take the shots even after the regulator’s assurance.
Underlying political reasons may have played a role in the suspension, given the problems that took place between the pharmaceutical company and the EU over delayed vaccine supply on one hand, and between UK and EU over the Brexit deal on another.
However, Dr. Salman ruled out a conspiracy theory and said that science should have the final word in resolving any suspicions.
He said, “The reasons behind the suspension vary between scientific and non-scientific. Scientifically speaking, most European states still have the luxury of choice, they still have Pfizer, Janssen and Novavax. But the impact will extend to other people who will fear the shot. Even after conducting the investigation, denying the reports, and proving the vaccine is safe, there would be a long-term effect, and there would be some skepticism, which will delay the immunization and cause subsequent loss of lives.”
Dr. Salman also pointed out that in the “follow-up of numbers vaccinated in England, the jab caused no casualties. However, among four million people who contracted the Covid-10 virus in England 130,000 died. Thus, out of 20 or 30 million people, the vaccine could be said to have saved 800,000 the lives. Moreover, given the spread of new Covid-19 strains, rapid vaccination is very crucial.”
According to risk assessment, the researcher said that the inoculation benefits outweighs the risks, which was the same conclusion reached by EMA late on Thursday.
“Results of 100 million people who received the vaccine will influence the final decision on that matter. Their data will be reviewed and it will be seen whether symptoms appeared in other people who are already vaccinated,” he added.
COMBINING DIFFERENT VACCINES
Further studies are announced to combine between various types of vaccines. One of these studies combines Oxford/AstraZeneca and the Russian Sputnik V vaccine.
How effective will these combinations be? Have any results emerged yet?
In this regard, Dr. Salman revealed that all vaccines target the spike protein of the virus, though they use different techniques. “In theory, as long as the individual vaccine is safe, they are safe when combined,” he commented.
He concluded, “We need to finish the study and analyze the findings in order to assess their combined efficacy and how long will it will last, then we will have to submit and review the results.”
