These are the crucial weeks in the fight against the coronavirus. While the number of infections is increasing in many regions of the world, temperatures are falling. We have to be indoors again, where the aerosols are floating around.
Now it is a race against time: who will be faster, the long winter or the researchers with their beneficial corona vaccines? The employees of Biontech are now on the home straight, a few weeks before a possible approval of the world’s first vaccine against Covid-19 – if you disregard the early approval of the Russian vaccine “Sputnik”, which is viewed very critically internationally.
The biotech company of the Mainz researcher and CEO Ugur Sahin, together with its partner, the US pharmaceutical giant Pfizer, is currently very advanced in its efforts to provide a vaccine. Two other projects, Moderna and Oxford University with Astra Zeneca, are also well advanced in their vaccine development. But the Biontech vaccine still has to overcome three hurdles before millions of people can get it.
1. Availability: a sufficient amount of vaccine doses
In order to vaccinate enough people in the world, billions of doses of vaccines must be produced. Biontech started manufacturing the vaccine weeks ago in its German plants in Mainz and Idar Oberstein, even before it was approved. Production has started to gain time.
So that millions of doses can immediately be sent to members of the government, nurses, doctors and paramedics at a possible approval date, the USA, the EU and Germany have secured a certain number of cans with their orders from Biontech, which can be called up gradually. It is not known how many million cans Germany has ordered from Biontech.
Long before the EU and Germany, the USA secured a total of up to 600 million cans in an agreement at the end of July for 100 million cans with the option of a further 500 million cans. Just a few days ago, Biontech announced the takeover of a plant for vaccine production in Marburg, which is now being converted for the production of the Covid vaccine.
The Mainz-based company plans to be able to manufacture up to 250 million doses of the potential vaccine in the Marburg plant in the first half of 2021. At full capacity, a capacity of up to 750 million cans per year is targeted. Around 300 employees work in the production facility. Biontech is one of the companies that could immediately supply a substance if it is approved.
2. Approval: green light from the authorities
Before the drug authorities approve the vaccine, they must continuously evaluate the results of the study data. The final phase of development, the Phase III study, is currently running with 30,000 to 44,000 subjects worldwide. Most people in the United States, Argentina and Brazil were vaccinated in the investigation because the pandemic is very raging there. More than 200,000 people have already died in the USA from the consequences or with the virus. For comparison: around 9,500 people have died in Germany so far.
So far, according to Anthony Fauci, White House health advisor, the data from the phase III study can only be viewed in the smallest of circles. According to a person familiar with the process, a confidential specialist committee, the Data and Safety Monitoring Board, will carry out an interim analysis of the Biontech Phase III study for the first time in mid-October. This is where the professionals may be able to see early on how successful and effective the vaccine is. They compare how many Covid-19 infections occurred in the group of subjects who received a sham vaccination with those in the group who received the mRNA vaccine.
At the moment, neither doctors nor vaccinated people know which product they are vaccinating or will be vaccinated. This is to ensure that knowing who is getting a placebo and who is getting the right vaccine does not affect the results of the study. If, at the end of the study, there are no or only one infected person among the 30,000 or so vaccinated, but 50 to 100 people in the placebo group infected with the virus, then the vaccine would be highly effective.
Political battle for emergency approval in the USA – even before experts have evaluated the data
The next step towards approval is then in the hands of Biontech and Pfizer, who could submit an application for emergency approval – an option that, in addition to Biontech, the pharmaceutical companies Moderna and AstraZeneca have already reserved. In the USA there are indications that there is a hurry there. President Trump has promised several times that a vaccine will be available before the fateful US election on November 3rd. Since then, a political battle for emergency approval has raged in the USA – even before experts have even evaluated the data in detail.
Even if the experts advise against an emergency approval and Pfizer did not apply for an expedited approval, the president could, by virtue of his office, approve the vaccine. This would, however, shatter confidence in the safety of the vaccine. The early approval may not be in the interests of Biontech, whose leading scientists want to finish their work to ensure an effective and safe vaccine.
Nine European and American pharmaceutical companies, including Pfizer, had therefore already signed a declaration in which they guaranteed safe and careful corona vaccine development. A vaccine will only be approved if it is fully safe and effective according to scientific standards, it says there.
3. Distribution and vaccination: The path of the vaccine to the patient
But the experts don’t just have to deal with the vaccine itself. An essential part of the work now consists, for example, of checking the temperature at which the mRNA vaccine has to be cooled and transported. “We currently have data that show that the vaccine can be kept for five days at two to eight degrees. Further data on the longer shelf life under these conditions are currently being collected,” said Ugur Sahin, CEO of Biontech, at a press conference in Marburg.
Currently, the study still recommends storing and transporting the vaccine at minus 70 to 80 degrees – which can only be done with extreme refrigerators. “The storage step is one that is usually checked last,” says Sahin. “We’ll know more in a few weeks. But safety comes first and we transport with great care. ”
The storage temperature and the consequences of this for the distribution of the vaccine were also recently discussed in an internal meeting at the Ministry of Health, according to a person familiar with the state of the discussion. Because general practitioners, who would carry out a large part of the vaccinations in Germany, usually do not have any extreme refrigerators. They store the ordered vaccines, for example against flu or against teething problems, in their specially designed practice refrigerators – at normal cooling temperatures.
If it turns out that the vaccine could only be kept in extreme cold in the medium to long term, it would be conceivable that the vaccinations would take place in clinics that have extreme refrigerators. At the same time, even with the first few million doses of vaccine, it is likely that they will not be stored in the refrigerator for several days, but will be used immediately. For example, hospital staff, police, fire fighters and government officials would be immunized first.
According to Anouk Hesen, head of UPS Healthcare in the Niederladen, opposite Deutsche Welle, cold stores are currently being built near UPS hubs in the USA and Germany, in which the vaccines can be stored in a cooler place. The freezers there are supposed to hold the sensitive vaccines first. If it later turns out that even conventional cooling temperatures in normal refrigerators are sufficient to safely transport and store the vaccine, then the process of storage and transport would be significantly simplified.