The Oxford-AstraZeneca COVID-19 vaccine is fast becoming a subject of notoriety. First, will States obtain it? Second, will they use it? The first answer has generally been affirmative, given the vaccine’s ease of storage and relative cheapness. The second is becoming increasingly difficult.
Orders have been made and supplies – some of them anyway – furnished, but vials and batches are not being used. Countries are either restricting or suspending the jab. AstraZeneca finds itself mounting what can only be a round-the-clock communications battle trying to dissuade officials not to put the brakes on.
Various artillery pieces have been marshalled against it. In late January, French President Emmanuel Macron expressed disappointment with the vaccine a mere few hours before the European Medicines Agency (EMA) approved its use on all adults. “The real problem on AstraZeneca is that it doesn’t work the way we were expecting it to,” he told press members. “We’re waiting for the EMA results, but today everything points to thinking it is quasi-effective on people older than 65, some say those 60 years or older.”
Even before any rollout, the vaccine’s name was already being blackened, if not smudged. The EMA’s words of approval (“as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults”) seemed lost in the noisy scepticism being promoted by such outlets as the Handelsblatt. In late January this year, the finance paper claimed that the vaccine “apparently has an effectiveness of only 8% in the elderly”, an assertion drawn from an “anonymous government source”. A follow-up story did not allay any doubts, with the paper insisting it had the words of an unnamed health ministry bureaucrat. “Confusion is out of the question. According to data available to us so far, effectiveness in people over 60 is less than 10%.”
The falseness of the claim did little to trouble the paper’s political correspondent, Gregor Waschinski. “I understand that some would like to see the story substantiated with actual data,” he tweeted. “However, this is not an academic preprint but a sourced piece of political reporting.” This reduction of scientific accuracy to political, sloppy expediency prompted Markus Lehmkuhl, a science communications academic based at the Karlsruhe Institute of Technology, to despair. “Precise scientific information” had been attributed to one “unsuitable source, who, to make matters worse, did not want to be quoted by name.”
Recommendations from various countries advocating not using AstraZeneca’s vaccine for the elderly subsequently proliferated. STIKO, the German Standing Committee on Vaccination, was quick in recommending against using the vaccine for those aged 65 and over. The Committee head, Thomas Mertens, tried to clear the air of confusion induced by the Handelsblatt’s reporting. The recommendation was “not about critique of the vaccine, but of the lack of data,” he told the BMJ. “When there is more and better data, STIKO will change its recommendation.”
France followed. “This recommendation will be re-examined in the light of availability of additional data,” promisedFrance’s national health authority HAS. Sweden’s Public Health Agency also revealed it was waiting for data “from an ongoing and large US clinical trial in Phase 3” that “will include a sufficient number of older participants to be able to draw more certain conclusions regarding the protective effort.”
In South Africa, a more drastic step was taken. Use of the Oxford-AstraZeneca vaccine was totally suspended, with fears about efficacy, notably against the South African COVID-19 variant. The February 10 announcement from the Health Minister Zweli Mkhize showed a tilting of the government towards the Johnson & Johnson candidate. “Given the outcome of the efficacy studies [the government] will continue with the planned phase one vaccination using the Johnson & Johnson vaccines instead of the AstraZeneca vaccine.”
The latest round of concerns centre on whether the vaccine, or certain batches of it, have encouraged the forming of blood clots. Italy’s medicines authority AIFA took what it called a “precautionary” measure to ban the ABV2856 batch after the deaths of two men in Sicily following inoculation. The agency added that no link had yet been established between the vaccine and subsequent “serious adverse events.” Austria’s own decision to suspend use was directed at the company’s ABV5300 batch after a woman died 10 days after inoculation due to “severe blood coagulation problems” (multiple thrombosis).
Batch ABV5300, delivered to 17 EU countries, compromises 1 million doses. Of those, suspensions as precautionary approaches have taken place in several countries, including Estonia, Lithuania, Latvia and Luxembourg.
Rumbles have also been registered in Scandinavia after Denmark recorded the death of a 60-year-old woman from a blood clot after receiving a dose from the ABV5300 batch. A two-week suspension of shots was imposed. “It is currently not possible to conclude whether there is a link,” wrote Health Minister Magnus Heunicke on Twitter. “We are acting early, it needs to be thoroughly investigated.”
Norway did not wish to be out of step. “This is a cautionary decision,” chorused the director of infection prevention and control at the Norwegian Institute of Public Health (FHI). The duration of the suspension was not clarified. “We … await information to see if there is a link between the vaccination and this case with a blood clot.” And just to make the picture complete, Iceland joined the vaccine suspension family.
On March 11, the EMA tried to stem any prospect of panic. “There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.” It added that the benefits of the vaccine “continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.”
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) called the measure by Iceland, Denmark and Norway merely “precautionary”. “It has not been confirmed that the report of a blood clot was caused by the AstraZeneca COVID-19 Vaccine. People should still go and get their COVID-19 vaccine when asked to do so.”
Speaking for the MHRA, Dr Phil Bryan stated that, “Blood clots can occur naturally and are not uncommon. More than 11 million doses of the COVID-19 Vaccine AstraZeneca have now been administrated across the UK.” The reported blood clot cases were “not greater than the number that would have occurred naturally in the vaccinated population.”
The medical wisdom on this remains consistent: certain adverse events will happen; comorbidities can play a distracting role. To quote Dr Peter English, till recently Chair of the BMA Public Health Medicine Committee, the introduction of a new vaccine with “reports of adverse events such as this” was far from “unusual”. On the contrary, it showed “that adverse reaction monitoring systems are working” rather than indicating a causal link between the reaction and the vaccination.
A meaningful strategy against pandemic suppression is not merely whether successful vaccines can be made, let alone successfully delivered, but whether the communications work. Unfortunately for the Oxford-AstraZeneca vaccine, the patchy reputations of pharmaceutical giants, and the specific way reports on the efficacy of the product have gotten traction, have damaged it. The risks of being Handelsblatted are never far away.Print