VAR CHECKS ASTRAZENECA’S VACCINE

AstraZeneca has made a very effective vaccine, as indicated by clinical trials and the protection seen in the countries where it is being used. However, his image has been affected by various circumstances. After the clinical trials, there was a dance of numbers in terms of its efficacy. Moreover, they did not deliver the agreed doses to the European Union within the agreed deadlines. It is a pity that its image has deteriorated because the AstraZeneca vaccine has very positive things. For example, the company decided to offer its vaccines at non-profit pricing to be the mainstay of the COVAX program of the World Health Organization (WHO) and UNICEF program, which aims to help countries with fewer economic resources vaccinate. Also, the AstraZeneca vaccine is almost ten times cheaper than RNA vaccines (€ 2-3 vs. € 20-22). Besides, its logistics is much simpler because it does not require freezing and can be kept refrigerated. However, let’s say your marketing and communication department will not receive any awards in the pandemic aftermath.
Faced with this situation, they must have thought that there is no better facelift than a name change. Thus, since March 25, the AstraZeneca vaccine is called Vaxzevria, which sounds like a half British half Swedish name, like the company.

A name change for marketing reasons was also suffered by the player Jesús Manuel Corona, a Mexican international player who currently plays for Porto. Jesús Manuel was asked to forget his last name Corona for a while, but in this case, the coronaviruses had nothing to do with it. It happened before the pandemic several years ago. It turns out that Jesús Manuel Corona played for Monterrey, a team whose main sponsor was a brewery that produced Carta Blanca and Tecate beers. «No way man», the sponsor must have said when he saw that Jesús Manuel’s shirt had Carta Blanca beer on his back, and below it was Corona, the player’s last name, but also the name of his main competitor’s beer. To don’t give more credit to the super famous coronita beer, Jesús Manuel Corona was renamed Tecatito in honor of Tecate beer, and this nickname accompanies him throughout his career.

A few weeks ago, I wrote about a penalty shoot-out between Pfizer and AstraZeneca vaccines. Penalties did not give victory to either of the two vaccines. A five-goal tie served to show that both types of vaccines were excellent and beneficial. However, in recent days, doubts have arisen about the fifth penalty, the one referring to secondary effects. Some say that AstraZeneca doesn’t deserve a goal on that particular penalty shot. These doubts arise because a pharmacovigilance system works like VAR, looking at even the smallest detail on a multiscreen and from different angles. Let’s review some of those VAR screens.

In «COVID-19 told through Football/Soccer«, our VAR screens have been scientific publications reviewed and filtered by editorial committees and scientists. However, in rare blood clots associated with Vaxzevria, scientific journals have not yet appeared. Therefore, we have to access the VAR of health agencies that compile and study vaccination data and side effects.

BRITISH GOVERNMENT VAR SCREEN

When comparing vaccines, the comparison should be made in the same population, at the same time, something that did not happen during the clinical trials of each of the COVID-19 vaccines. Fortunately, the UK has been vaccinating in parallel with Pfizer and AstraZeneca vaccines. Therefore, the UK, where 20.2 million people have already been vaccinated with the AstraZeneca vaccine, is a good screen to look at the side effects of both vaccines.

The UK Medicines Regulatory Agency (MHRA) published a note on April 7, 2021 stating that there was a POSSIBLE link between Vaxzevria vaccination and EXTREMELY RARE blood clots coinciding with low blood platelets.

Out of 20.2 million vaccinated with the AstraZeneca vaccine, 79 cases of these rare blood clots have been reported in the UK. Of these 79 people, 19 died. So approximately, for every million people vaccinated with AstraZeneca, four suffered from these blood clots, and one died. In other words, one person per million vaccinated died.

Of the 79 cases, 51 were women. Of the 19 who died, 13 were women. This data is consistent with other observations in Germany, indicating that these very few rare blood clots are more common in women than in men. British experts question this correlation because more women than men have been vaccinated with AstraZeneca in the UK. However, there is a strong correlation with age because most rare blood clots have occurred in people under 60 years of age (in the UK, Holland, Germany …) (see ANNEX).

Therefore, if only those older than 60 years are vaccinated, rare blood clots would be reduced by 80%. Thus, we would have a theoretical mortality rate of 0.2 people per million, or one person in five million. This rare blood clot risk correlation with younger people would reassure Kazuyoshi Miura, a Yokohama FC player in the Japanese first division, who at 54 is the oldest professional player.

EMA has committees for specific topics. The Pharmacovigilance Risk Assessment Committee (PRAC) has published a report on 86 rare blood clots among 25 million vaccinated, which resulted in 18 deaths. These cases are from the European Union and the United Kingdom, so there may be some overlap with the British data. In fact, the percentages of risk of death are similar, one in a million. This EMA report is from March 23rd. On April 4 the EMA added a note to the report updating the data to 222 cases among 34 million vaccinated with Vaxzevria. I imagine that these cases need to be reviewed, but this would mean going up to 6.5 cases per million instead of the initial 4 per million. This increase has been influenced by data from the Paul-Ehrlich Institute that speak of 46 rare cases of thrombi in Germany (of which 9 died) in 2.7 million vaccinated, about three deaths per million.

BAR chats

VAR helps by offering detailed images, but sometimes there is room for opinion and interpretation. It touches him but not hard enough to throw it away — you’ve ever heard. Likewise, you can do a bit of a pub counter opinion on AstraZeneca’s rare blood clots. Listening to this type of comment is non-selective fishing that from time to time leaves you with a valuable piece that can change the way you see things.

It is said that taking contraceptives can cause blood clots with a high frequency, and it is. The EMA published a report in 2013 that said that if the frequency of blood clots in the general population is 2 per 10,000 people, in women taking contraceptives, it was 4 to 12 cases per 10,000. Considering that information, one could say that the possibility that a woman who takes contraceptives has a blood clot is 8 cases per 10,000, 80 per 100,000, or 800 per million.

Dude! That the frequency of blood clots from taking the contraceptive pill is 800 per million, and that from being vaccinated by AstraZeneca is less than 7 per million!- can be said in a bar chat.

But this is not right because these types of blood clots are different. Blood clots are relatively frequent in the population (1-2 cases per year per 1000 inhabitants), as is common today to see women’s soccer teams. However, the blood clots associated with Vaxzevria are different, very rare, surprising, and unexpected. Like no one expected the existence of a women’s soccer team in the Vatican, a city-state of just over 800 inhabitants where the majority are servants of God.

Another popular topic of conversation is to compare the risk of blood clots from a vaccine with that of having a traffic accident. In Spain, in Easter 2019, the last in which we could travel, there were 14.9 million trips, and 27 people died on the road. Approximately two people passed away per a million trips. A death rate very similar to getting the AstraZeneca vaccine with no restrictions on the age range. Also, if only people over 60 are vaccinated with Vaxzevria, the probability that they will die will be 0.2 per million, about ten times lower than the risk of dying from traveling by car at Easter.

In any case, it is not about pointing out, ridiculing, or pressuring someone who does not want to get the AstraZeneca vaccine, as you should not do it with someone afraid of traveling by car on vacation. If it is possible, it is necessary to inform if useful to face the fears. The Dutch Dennis Bergkamp was afraid of the plane, and even more when flying to the USA for the 1994 World Cup, someone joked with a bomb on board and then his plane had problems with the engine. After the World Cup, he signed for Arsenal, on the condition that he did not travel by plane, respecting his aerophobia. When Arsenal played in Europe, Bergkamp made long train journeys while his teammates flew.

AND NOW WHAT?

Since most of these rare blood clots occur in people under 60, the Spanish Ministry of Health has proposed vaccinating people between 60 and 69 years of age with Vaxzevria. It seems like a reasonable decision with the data now available. The age ranges will be set by each country depending on the availability of different types of vaccines. Germany proposes vaccinating people over 60 years of age with the AstraZeneca vaccine. Italy also restricts the vaccine to those over 60. France and Belgium to those over 55. Sweden to those over 65. The UK proposes avoiding the AstraZeneca vaccine only in those under 30 years of age. Denmark has it stopped for now. Costa Rica continues to vaccinate all ages.

IF I ALREADY GOT THE FIRST JAB, WHAT WILL HAPPEN?

Many people are waiting for the second dose of AstraZeneca (the second leg). The British Committee on Immunization and Immunization (JCVI) proposes that those who received their first dose without problems get the second since, for now, in the United Kingdom, they have not found any case of rare blood clots with second dose*(see update at the end). All rare blood clots were seen in the first dose*, although most have not received the second dose yet. However, France proposes to give the second dose with a different vaccine, although this would still be an «experiment» for which there are no clinical data.

To the relief of the crowd, the AstraZeneca vaccine already offers enough protection with a single dose, so running out of the second dose would not be a bad option, especially to achieve the desired herd immunity. If the antibodies go down in a few months, they could receive another vaccine and perhaps one optimized for the circulating strains.

At this point, it seems reasonable to give people the option to have their second dose voluntarily.

SCIENCE BEGINS TO PROVIDE SOLUTIONS TO THESE RARE BLOOD CLOTS

As the minutes of the game progress, we will know with greater precision what factors can cause these rare blood clots, and with that knowledge, we can avoid or treat them. In fact, an article has just been published (April 9) in the prestigious New England Journal of Medicine where autoimmune antibodies against a protein called PF4, detected in patients with rare blood clots using a relatively common technique called ELISA, could be the cause of these blood clots. This finding is a piece of good news because the patient at risk could be identified, and they also propose a treatment to avoid these rare blood clots. One more example that the accumulated knowledge makes science, sometimes faster than the 21-year-old Ronaldo Nazario.

DON’T FORGET THAT WE ARE A TEAM

We must bear in mind that we cannot stop the game because the rival continues to play and takes SARS-CoV-2 variants into the field. This game is played worldwide, and the curve of accumulated cases in the world is still far from flattening.

We have gone from fear for the coronavirus to the terror for vaccines. Some countries may be able to afford to use other vaccines to avoid those risks of one, or less than one, in a million. In this global match, we need a cheap, efficient, and amenable transportation logistical vaccine like Vaxzevria. Jannsen’s vaccine is similar to AstraZeneca’s (made of DNA and uses a benign adenovirus to encapsulate said DNA), but costs about 8-9 euros (although it requires a single dose). In the last few days, Jannsen’s vaccine is also upon VAR examination after detecting six cases (between the ages of 18 and 48) of rare blood clots after seven million doses administered. In Europe, the AstraZeneca vaccine represents a quarter of the vaccines that Europe has in store (see annex) and the great hope to vaccinate in countries without resources. Not taking the risk of getting vaccinated and taking the risk of having a complicated COVID-19 does not seem reasonable. For example, if you are between the ages of 60 and 70, you have a 2 in 100 chance of dying if you get COVID-19, and only a 1 in 5 million chance if you get vaccinated with the AstraZeneca vaccine. If you are between 20 and 50 years old, the chances of dying from COVID-19 are 0.2 to 0.4 in 100, and those of the rare blood clot are 1 to 3 in a million. In any case, we should think that when we get vaccinated, we protect ourselves and the elderly around us. What is the point of belonging to a team in which you neither play nor cheer, and which also does not take care of its elders?

VAR DECISION

The VAR room of «COVID-19 TOLD THROUGH FOOTBALL» maintains a tie at five between the Pfizer and AstraZeneca vaccines. Be careful with the protests because we could review a goal from Pfizer and Moderna for greed and blocking the patent to prevent the manufacture of vaccines in other places.

@raticosdefutbol

@ceronlab

Update April 13. The American CDC agency has published a note saying that it decides to make a temporary pause in the vaccination with the Janssen vaccine for having detected 6 cases of rare thrombi among 6.8 million vaccinated between 18 and 48 years of age. The numbers more or less coincide with those registered with the AstraZeneca vaccines, so this vaccine may also be intended for people over 50 years of age. The AstraZeneca and Janssen vaccines are DNA, enveloped by adenoviruses that are different in each vaccine.

Update May 1. An updated report from the British agency MHRA speaks of 209 «rare blood clots» in people with the first dose of the AstraZeneca vaccine. Of these cases, 41 died, without great biases between men and women, but with age. 88% of the cases were under the age of 69, and 73% of the cases were under the age of 60.