What many had regarded as an overly optimistic scenario now seems to be happening. Still in 2020, one or more vaccine candidates against the coronavirus could be approved in the EU. Two vaccines developed on basis of the novel mRNA technology are currently the most promising candidates – one developed by German company Biontech and US pharma giant Pfizer, the other by US biotech firm Moderna. For both vaccines, encouraging study results on efficacy have recently been published.
Biontech and Pfizer applied for emergency usage authorization (EUA) in the United States on Friday, Nov. 20. An official application in the EU is expected to follow soon; the European Medicines Agency (EMA) has already received parts of the data required for approval. EU Commission President Ursula von der Leyen also expressed optimism on Thursday, Nov. 19, that both the vaccine from Biontech and Pfizer and the vaccine from Moderna could be approved by the EU in the second half of December.
First Doses at the Beginning of Next Year
Health Minister Rudolf Anschober (Greens) showed himself optimistic “that the first vaccine doses can be delivered to Austria as early as January.” Herwig Kollaritsch, a specialist for prophylaxis and tropical medicine in Vienna, told the ORF that vaccination in Austria will start “with high probability” in the first quarter of next year.
Kollaritsch is also a member of the national vaccination committee – and thus one of currently 18 experts who advise the ministry on vaccination recommendations. The expert commission is also involved in the development of a strategy for a future CoV vaccination program. Among other things, the vaccination strategy will have to determine for which groups the vaccine will be made available first. It also needs to answer legal questions and provide a framework for logistics and documentation of the vaccination.
Vaccination Strategy in “Next Weeks”
Germany already published a first – quite rough – timetable at the end of October. In Austria, the plans are not yet publicly available in written form. However, a document on the matter is “to be published in the next few weeks,” the Ministry of Health said at the request of the ORF. As far as communication and logistics are concerned, the ministry says that it intends to follow the recommendations of the EU Commission, which were published in mid-October. One thing is already certain according to the ministry: “The vaccine will be free of charge.”
At the beginning, vaccines will only be available in very limited quantities. The EU has already negotiated contracts with several vaccine makers for the fixed delivery of hundreds of millions of doses. But it will be a long time before production of an approved vaccine is fully up and running. This also applies to the vaccine from Biontech and Pfizer, the current frontrunners. The EU has secured a total of 200 million doses of this vaccine, which will be distributed among the member states according population size. Austria would thus receive four million vaccine doses. For full immunization, two vaccine shots are needed, so this quantity would suffice for vaccinating two million people (out of a total Austrian population of 8.9 million).
By the end of this year, Biontech and Pfizer will have produced just 50 million vaccine doses – for the entire world. For 2021, they promised to produce 1.3 billion doses.
Who’s Going Get It?
Governments have thus to decide where to start with a vaccination program to have the most impact and quickly protect those most in need. Austria’s health minister spoke of a plan with “four stages.” In the first stage, old people in senior homes and nursing homes should be vaccinated.
Then, business, chambers and unions will be approached to work out a plan to vaccinate workers on active duty in companies. Austria’s Ministry of Health emphasized areas where “the greatest systemic risk exists” as the priority. On the one hand, this concerns people with an increased risk of a serious or fatal course of disease, and on the other hand “the personnel working in health and care facilities.”
This prioritization of first “vulnerable groups” and then “exposed and vulnerable groups” was recommended by the EU Commission and is also the principle Germany follows in its vaccination strategy.
Effectiveness for Older People Is High
A prerequisite for such a strategy is that the vaccine is well tolerated by elderly people and that it immunizes them effectively. Specialist Kollaritsch said that exactly such efficacy seems to have been confirmed, at least for the two mRNA vaccine candidates. In the Phase III study by Biontech and Pfizer, more than 40% of test subjects were between 56 and 85 years old. For them, the vaccine showed an efficacy rate of over 90%, just as with other (younger) participants.
Prevent Disease or Brake Transmission?
While vaccinating vulnerable people first may seem obvious, for a while, another strategy was also discussed: To start with those who have the most social contacts and thus are most likely to spread the virus.
However, it is not yet clear to what extent the vaccines not only prevent a (serious) disease, but also prevent transmission of the virus. Expert Kollaritsch does not expect the first-generation of vaccines to completely prevent transmission. Encouragingly, though, recent study results indicate that the high effectiveness of the vaccines “probably” also “reduce” the transmission rate. That is why it makes sense to “gradually spread [the vaccine] to the masses” as the vaccinations program progresses.
What seems to be sure at this stage is that children will not be a part of this first wave of vaccination. Any emergency authorization in Europe will only be approved for people older than 18 years.
Vaccine doses for everyone are still far away anyway, though. Even the vaccination of the now prioritized group already represents a huge logistical challenge: 120,000 people in Austria work in the inpatient healthcare sector, i.e. in hospitals, nursing homes and homes for the elderly. Another 170,000 or so health professionals work in the private healthcare sector. If you add the population over 60 years of age, that is another two million people. According to the Ministry of Social Affairs, about 110,000 of them live in old people’s homes or nursing homes.
A Freezing Logistical Challenge
The Biontech/Pfizer vaccine will probably be the first to be approved – and it is also the one that poses a particular logistical challenge: For longer periods, it can only be stored at very low temperatures. The freezers must reach around minus 70 degrees Celsius to prevent the mRNA on which the vaccine is based from decomposing. The German postal service DHL, which is heavily involved in pharmaceutical logistics in Europe, is therefore considering to purchase several hundred freezers (Ultralow Freezers) for its warehouse network.
Health expert Kollaritsch sees Pfizer on a good way to preparing the logistics in the background. “They’ll get that done,” he expressed confidence to the ORF.
For example, Pfizer developed special refrigerated boxes to transport the vaccine and store it for a period of time also outside specialized freezers. According to Kollaritsch, these are small transport units in which dry ice ensures the low temperatures. Austria’s domestic pharmaceutical logistics industry has also recently expressed confidence to the Salzburger Nachrichten that it can handle the challenges of vaccine distribution.
Use for E-Vaccination Pass?
A further – at least small – challenge is administering the vaccine. Initially, the vaccine will probably be delivered in “multi-dose containers,” according to the Ministry of Health. This means that the vaccine will not be delivered in individual doses in a syringe, as is the case with common vaccinations, but in glass vials with pierceable lids. For each vaccination, a syringe would then have to be drawn up first – which would mean at least some additional work.
Then there is the question of how a successful vaccination will be documented. According to the Ministry of Health, “documentation of vaccination will be an essential part of a COVID-19 vaccination program.” Plans are currently being drawn up for concrete implementation. An e-vaccination pass was already planned before the pandemic and might now be expedited for this purpose.
Acceptance as the “Great Unknown”
The legal and logistical challenges can probably be overcome with good planning. Another factor – just as important for success – is more difficult to predict: How many people will be willing to get a vaccine shot? According to current surveys, just over 50% of the population are willing to be vaccinated. However, this could quickly change if a vaccine program is up-and-running and an open debate ensues.
Kollaritsch pointed to a “high degree of transparency” as a crucial factor to win people’s trust. Clearly communicating how the vaccines work is essential. That also means transparently communicating possible side effects and risks. Vaccinations have to meet very high safety standards “because they are administered to healthy people who are not suffering from any medical condition.” That the vaccine manufacturers disclose all of their data – which, so far, they vowed to do – will be an important step in that regard.
If all goes well, then, 2021 will begin not with a champagne cork pop – but with a shot of the vaccine that will start to put an end to this pandemic.