What's wrong with the Oxford vaccine?

AstraZeneca made a mistake and discovery

Andrey Gurkov, Deutsche Welle

The prompt registration of one of the most promising coronavirus vaccines developed by the British-Swedish pharmaceutical company AstraZeneca together with scientists from the University of Oxford has come into question. She is likely to need additional clinical research. This may significantly slow down the upcoming mass vaccination in the UK and the European Union, as well as strengthen the competitive advantages of the Russian Sputnik V vaccine in the markets of Asia, Africa and Latin America.

Oxford vaccine: different results in two groups of volunteers

With the so-called "Oxford vaccine" AZD1222, something happened that has happened more than once in the history of world science: an important discovery was made as a result of chance and even error. However, if we are talking about medical drugs, then any laboratory error immediately attracts increased attention. Especially in the conditions of a growing pandemic, when humanity, on the one hand, is waiting for the opportunity to get vaccinated reliably from the virus as soon as possible, and on the other hand, is vigilantly watching the accelerated creation of vaccines by different manufacturers and their competition among themselves.

Briefly the essence of what happened. On Monday, November 23, AstraZeneca and Oxford University published the results of clinical studies, according to which the effectiveness of their vaccine is on average 70%, and in some cases 90%. "We have a vaccine for the whole world," said Andrew Pollard, head of the Oxford Vaccine Group.

After all, the features of this particular development are that it will cost very little (presumably $ 5 for two doses) and it can be stored and transported in conventional refrigerators. This radically distinguishes it from the German-American vaccine of BioNTech and Pfizer, which requires a temperature of minus 70 degrees Celsius, which, of course, significantly complicates logistics, especially outside of industrialized countries.

However, questions arose. Why AstraZeneca injected one group of volunteers consisting of 2,700 people with half a dose first, and a month later a full dose, while a much larger group of about 8,900 people received two full doses. And why in the first case the efficiency turned out to be at a very good level of 90%, in the second it reached a not very convincing 62% (on average, it turned out to be 70%).

Harsh criticism of AstraZeneca's information policy

"We used half the dose by a lucky chance," Mene Pangalos, who is responsible for all non–oncological research and development at AstraZeneca, admitted to the Reuters news agency on the same day. It turned out that there was a banal mistake: they just injected the wrong dose. Moreover, it was the fault of the manufacturer, who delivered a substandard batch. Thanks to this, however, they made the discovery that the "half dose + full dose" scheme is not only much more effective, but also more gentle.

After all, they came out on the trail of the error after they noticed that volunteers from this group less often complain of side effects such as drowsiness, headache and pain in the arm at the injection site.

Nevertheless, the fact remains that during the clinical trials of the Oxford vaccine, dosage deviations were made, which immediately caused very strong criticism from the international expert community – not the vaccine itself, which just showed encouraging results, but AstraZeneca's reporting methodology and its information policy.

The key reproach: the company actually combined two different studies in one report, and the promising one-and-a-half dose scheme was tested only on 2,700 volunteers, which is clearly not enough for final conclusions about the effectiveness and safety of the vaccine.

In addition, the experts noted that in this group none of the vaccinated was older than 55 years. So this scheme has not been tested on the elderly. And Oxford scientists in a publication in the authoritative medical publication The Lancet just pointed out that their vaccine worked especially well on representatives of the older age group.

AstraZeneca Announces Additional Research

Less than three days of harsh critical speeches by experts, on Thursday, November 26, the head of AstraZeneca, Pascal Soriot, announced the start of new vaccine trials designed to supplement the results already collected. Nothing is known about its scale and duration yet. But in any case, the registration of the Oxford vaccine almost in the coming weeks, which could have been expected until very recently, now seems unlikely.

However, on Friday, November 27, the UK Ministry of Health gave the National Medicines Supervision Authority an instruction to study the development of Oxford University and AstraZeneca and stressed in its statement that this is "the first, significant step towards the registration of a vaccine, provided that it meets the standards of safety, efficacy and quality."

However, this looks more like a demonstrative gesture of principled political support than an attempt to artificially speed up the admission of the drug. It would be very counterproductive in a situation where the creators of the drug themselves consider further research necessary, and would undermine the credibility of the Oxford vaccine in the world. Moreover, for her global success, the British registration alone is definitely not enough. And regulators, say, in the European Union and the United States, under the circumstances, are unlikely to want to force events.

The chances of the Sputnik V vaccine in foreign markets have increased

So the release of the Oxford vaccine to the world market is postponed indefinitely, and this can have a number of significant consequences. For the UK, this could mean a serious delay in mass vaccination, because London ordered 100 million doses of this two-component vaccine in advance, which would statistically provide vaccination to 50 million residents of the country with a population of 66 million people.

BioNTech/Pfizer or the American corporation Moderna has ordered 300 million doses from the European Union, and the delay in their delivery may lead to the fact that for several weeks or even months vaccinations in the EU will be made exclusively with innovative mRNA vaccines produced by BioNTech/Pfizer or the American corporation Moderna. They are more expensive and for many people more unusual than more traditional vector vaccines.

Both Oxford and Russian Sputnik V vaccines belong to this kind, so they are direct competitors in terms of technology, price, and orientation to the countries of Asia, Africa and Latin America. It is no coincidence that the Russian Direct Investment Fund (RDIF) on November 26 proposed that AstraZeneca, weakened due to international criticism, combine both vaccines.

This would make it possible to avoid confrontation in the most promising areas and, perhaps, even achieve joint dominance in some countries. At the same time, the current delay in the registration of the Oxford vaccine provides RDIF with a certain head start in promoting its Sputnik V vaccine to foreign markets.

In addition, this story shows that the international expert community is closely monitoring the development of drugs for coronavirus everywhere in the world. So the harsh criticism to which experts subjected the circumstances of the registration of the Russian vaccine "Sputnik V" in August of this year, it is unlikely to be attributed to a biased attitude towards Russia. 

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