Professor Usonis on ‘sixth’ dose of coronavirus vaccine: alarming estimate

Vytautas Usonis, a professor at the Vilnius University School of Medicine and a doctor of medical sciences, who was asked by the Delfi portal to evaluate the manufacturers’ recommendations, said the dose calculation caused him some concern.

After reading the manufacturers’ recommendations, the professor drew attention to the established conditions.

«To obtain six doses, special syringes with a dead volume of not more than 35 microliters should be used. In other words, the syringes are not suitable, they must be special ”, said Professor V. Usonis.

The recommendation states that if standard syringes and needles are used, the vaccine may not be sufficient to draw the sixth dose from the vial.

It is also important to note that if 0.3 ml is not sufficient for the sixth dose after the fifth dose has been drawn, this is to ensure that the remaining contents of the vial cannot be used. The vial must be discarded.

“The dose cannot be taken from several different vials. If there are not six doses in the vial, the sixth dose is discarded and only five remain. Vaccine residues from several vials cannot be collected in one, the EVA made it clear, ”said the interviewee.

As stated in the EVA recommendation, the vaccine should not be drawn from multiple vials to make the full dose and any unused vaccine should be discarded 6 hours after dilution.

When asked to explain why the vial contains more than the declared amount, the professor said: “When using multi-dose vials, always fill more than the declared dose. This is a requirement of the World Health Organization. It should be filled with 10-15%. more than the stated doses. This is to cover all errors and to ensure the number of doses is reported.

In the case of BioNTech and Pfizer, this was also the case at the beginning, with five doses of 0.3 ml each.

The actual volume of the vial after dilution is 2.25 ml. But mistakes can happen during production, packaging, bottling, especially with such small quantities of vaccines. Mistakes can happen when preparing a vaccine: after all, living people work. To compensate for all these errors, more is added.

Volume can be saved by using that special equipment – smaller syringes, and the staff has to work with great precision and precision. When working normally with syringes, some liquid remains in the needle. Part of the vaccine remains in the syringe. There, a minimal amount remains, but since the dose of this vaccine itself is only 0.3 ml, that amount can become significant. However, if a person is given too little, the vaccine may not work. “

And while the increased volume in the vaccine vial, as mentioned, seems to ensure that the human dose does not decrease due to a possible error, the huge demand for the COVID-19 vaccine around the world and the enormous pressure on the US and European pharmaceutical agencies to accelerate human vaccination. , resulted in recommendations on the so-called “sixthDose.

Professor V. Usonis said that to date, as far as he knows, no analogues existed when the drug manufacturer would recommend legalizing the use of higher vial doses than declared.

“At least that I know of, this has never happened before, because there are a few more of those vaccines in the vials. The use of a multi-dose vial itself is very old and well known. But in most cases the opposite happened, there are many doses and something unused. And this practice of vaccinating more doses than declared will probably be applied for the first time, “said Professor V. Usonis.

At the same time, the interlocutor pointed out: one thing about the “sixth“Doses can even be useless. BioNTech and Pfizer are in danger of counting that five people will now be vaccinated with a vial of Comirnaty vaccine, so fewer vials can be supplied to Lithuania than agreed.

“We are talking about all this simply because we want to vaccinate more people. If, for example, they send us 100 vials and we know that 500 people need to be vaccinated, but we will use special syringes, special care personnel and 600 will come out of them, then it makes sense to talk about something and tell something. But if they tell us that of the same 100 vials there are not 500 but 600 doses, what do we gain? If this is the case, in my opinion, it would be very useless for us, “said Professor V. Usonis.

Gytis Andrulionis, head of the State Agency for Drug Control (VVKT), confirmed to the Delfi portal that Lithuania would receive a lower number of vaccine vials due to the legalization of the “sixth dose”.

“It just came to our notice then. The contract stipulates how many doses we buy, not the vials. If there is a five-dose container, there will be a number of vials, if there is a six-dose container.

We are still trying to negotiate with the company. The company received our inquiry as to whether the package could be treated as six doses in all cases where it relies on syringes. After all, if we use the wrong syringes, those six doses may not work. We are trying to negotiate even more favorable conditions so that in all cases they are not counted as six-dose containers, ”said G. Andrulionis.

After clarifying what are the benefits of the “sixthAndrulionis explained: “The benefit is that we don’t throw away waste and everyone will get vaccinated faster. It is planned how many containers and boxes will be manufactured. If we allow it to be officially vaccinated at 20%. more people, but the number of boxes will remain the same, vaccination will continue to accelerate throughout the European Union. “

As mentioned above, once the “sixth dose” is legalized, special smaller volume syringes must be purchased. This is indicated in the immunization record review. Would this mean that Lithuania would have to buy additional equipment for vaccination?

“No. But we pass that information to the Department of Health so that they can evaluate whether or not to vaccinate with said syringes. If it is with another, then the characteristics must be considered. But if the syringes are adequate, then six doses and so on,” he said. the head of IWT.

Manufacturer’s recommendations for the ‘sixth“The doses will take effect in Lithuania when it is approved by the EC.

“The Lithuanian Ministry of Health does not want to take risks, we want to achieve it through a joint decision. When the EC approves, we will inform the Ministry that it can now inform the institutions about the possibility of withdrawing the sixth dose,” clarified G. Andrulionis.

Some countries, like the United States and the Czech Republic, are already drawing six doses from the vial, if possible, instead of the five recommended by Comirnaty’s vaccine manufacturers so far.

“The Ministries of Health of the Parties may make such a decision. But in Lithuania it was decided not to accept it, but to wait for it together,” said the head of IWT.

The Comirnaty vaccine against COVID-19 was developed by the pharmaceutical companies BioNTech and Pfizer. The vaccine is intended to prevent the spread of COVID-19 in people over the age of 16. The vaccination registry was approved on December 21, 2020.