Utilization rate increases, supply decreases： Pfizer and EU have a dispute over vaccine supply in COVID-19.

Recently, many countries around the world have started large-scale vaccination programs, but the global epidemic situation is still grim, and every link of vaccine supply makes governments particularly nervous. On January 8th, the European Medicines Agency (EMA) updated the regulations, allowing the COVID-19 vaccine jointly developed by Pfizer and German company BioNTech to take 6 doses of vaccine per bottle, one more dose than before. This seems to be good news, but the move by pharmaceutical companies to reduce the supply of vaccines has caused a storm.

On December 28th, 2020, in a hospital in Rome, Italy, medical staff prepared for COVID-19 vaccination. Xinhuanet

One bottle =6 doses of vaccine?

Pfizer -BioNtech vaccine is packaged in a small glass bottle, and it needs to be extracted with a syringe when it is injected. When European Medicines Agency（EMA） approved the vaccine in December last year, it stipulated that a bottle should extract 5 needles. According to the British "Financial Times" reported on January 20th, some health professionals have found that there are often extra vaccine liquid left in the bottle. Xinhua News Agency previously quoted the Associated Press as saying that pharmaceutical companies usually inject more vaccines into bottles than needed to ensure that sufficient doses can be provided even if there are losses such as spillage.

Pfizer and BioNtech decided to reduce the number of vaccine bottles shipped to European countries in view of the increase in the dosage that can be extracted from each bottle. According to a statement sent by Pfizer to the Financial Times, the company can make such adjustment because the delivery agreement between the company and governments has always been based on "dose" rather than "vial" quantity.

Drug regulators in the United States and the United Kingdom have also suggested that 6 doses of vaccine can be extracted from each bottle. British supply contracts with Pfizer and BioNTech are also based on dosage rather than vials.

Pfizer also said that it will supply to countries according to the supply agreement and the effective dose label on each bottle of vaccine, and will fulfill its supply commitment according to the existing agreement.

However, for practical operation, this adjustment is not just as simple as changing the dose of each bottle. In order to ensure that 6 doses can be extracted from a bottle of vaccine, medical personnel must use a special "low dead volume syringe".

It is understood that this syringe is specially developed for COVID-19 vaccine. The so-called "dead volume" comes from the gap between the plunger and the needle of the syringe, which will leave a small amount of vaccine liquid, while the low dead volume syringe can reduce the amount of vaccine left.

But even if this syringe is used, it does not mean that the "complete sixth dose vaccine" can be extracted from a bottle. Medical staff may need to extract as much vaccine liquid as possible from one vaccine bottle, and then combine it with the liquids extracted from other vaccine bottles to form an appropriate dose and inject it into the human body.

However, European Medicines Agency（EMA） expressed its opposition to the practice of "mixed vaccine". The agency warned that if the residual liquid in a single vaccine bottle is less than 0.3 ml after pumping 5 doses of vaccine, it should be discarded together with the vaccine bottle.

On December 27th, 2020, a medical worker was vaccinated with COVID-19 in an infectious disease hospital in Bucharest, Romanian capital. Xinhuanet

Pharmaceutical companies reduce supply and vaccination plans slow down.

Although the EU allows one more dose of vaccine per bottle, the actual landing is not easy. After the vaccine supplier announced a reduction in delivery, health officials across Europe warned that the change in delivery prevented them from completing the vaccination schedule set at the beginning of this month and carrying out the first vaccination for enough people.

The health department in Hamburg, Germany, said that this change means that the vaccine vaccinated now is about 20% less than before. Melanie Leonhard, head of the department, said that the epidemic situation in this area is getting worse with the further tightening of vaccine supply.

Pfizer -BioNtech vaccine has been widely inoculated in the European Union since December 27th, 2020, but about one third of the EU member states complain about insufficient vaccine supply.

In November last year, Pfizer and BioNTech reached an agreement with the European Commission to supply 200 million doses of COVID-19 vaccine in 2020 and 2021, and the EU has the right to purchase up to 100 million additional doses. It is understood that the vaccine delivery will be carried out in stages to ensure the fair distribution of vaccines within the EU according to the terms of the contract. Vaccines for Europe will be produced at BioNTech’s manufacturing plant in Germany and Pfizer’s manufacturing plant in Puurs, Belgium.

In addition to reducing the supply due to the "six doses per bottle" regulation, Pfizer and BioNTech issued a statement on January 15 this year, saying that in order to achieve the goal of increasing vaccine production, the company changed its production process, which would "temporarily affect" the vaccine delivery progress from the end of January to the beginning of February.

Domenico Arcuri, Commissioner of the Emergency Committee of Covid-19, Italy, said earlier that Pfizer will cut the vaccine dose delivered to Italy by 29% from January 18th, and this situation will continue after this week.

Will the "saved" dose be supplied to developing countries?

The decrease in supply caused by the adjustment of production process, coupled with the impact of the new European Medicines Agency（EMA） guidelines on the dosage of each bottle, has led to increased tension between Pfizer and BioNTech and European governments.

Arcuri said that Italy planned to take legal action against Pfizer "in the next few days". "The vaccination work cannot be slowed down, especially for Italians who have already received the first dose of vaccine."

Some EU member states have called on the EU to take a tough stance against Pfizer and other vaccine suppliers. An EU diplomat said: "We need the European Commission not only to act as a coordinator with pharmaceutical companies, but also to negotiate with them on behalf of 450 million Europeans." The official also said, "Only by taking a tough stance can 70% of adults be vaccinated before summer."

Pfizer and the European Commission held an emergency conference call on January 18th to discuss how to ensure that all countries can extract the sixth dose of vaccine from each bottle and the future production schedule.

In a statement to the Financial Times, the European Commission said that Pfizer and BioNTech "must respect" the vaccine delivery reached with the EU. The European Commission "very much welcomes" the extraction of the sixth dose from a bottle of vaccine, but at the same time emphasizes that it is not allowed to waste any dose or bottle of vaccine.

People familiar with the matter told the Financial Times that according to European Medicines Agency（EMA）’s guidelines, Pfizer believes it is only fair to fulfill its contractual obligations with European countries and supply the remaining doses to developing countries.