Wednesday, December 02, 2020
The British health authorities have granted emergency approval for the corona vaccine from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer. According to the government in London, the vaccine will be available as early as next week.
In other countries too, vaccination campaigns could start in December and herald the end of the pandemic. Many people are still skeptical: How safe are the vaccines developed at record speed?
Side effects usually occur early
Statistics show that almost all vaccination side effects occur in the first six weeks. The participants in the large-scale studies for the vaccines from Biontech / Pfizer and the US company Moderna were observed for at least two months after administration of the second dose – as required by the US FDA for emergency approval.
“There’s a difference between fast and too fast,” says Saad Omer, director of the Institute for Global Health at the US elite Yale University. An observation period of two months actually covers the “overwhelming majority” of undesirable side effects, he says.
Typically, the FDA requires six months of observation. If the first eight weeks after vaccination go well, it is very unlikely that you will experience any side effects in the next four months.
So far no serious unintended consequences
Biontech / Pfizer and Moderna assure that none of the test persons experienced serious side effects in the two months after the second injection – that is, life-threatening consequences that make hospital treatment necessary or permanent impairments. This category includes allergic shocks or neurological problems and, in the worst case, death.
According to the company, a small proportion of the test subjects suffered from side effects such as fatigue, headache and joint pain and a reddened and painful injection site, especially after the second dose. The approval authorities evaluate far more and more detailed data than the companies announced in their press releases.
Large number of test subjects
To underline the seriousness of the current studies, reference is made to their large scope: there are 44,000 volunteers at Biontech / Pfizer and 30,000 at Moderna. The health data of tens of thousands of test subjects are therefore available to the regulatory authorities. In the past ten years, vaccine studies have included an average of only 6,700 test subjects.
Further monitoring of the vaccine effect
The effect of the vaccines will continue to be monitored after approval. In the USA and Europe there are well-established systems for statistically recording a possible increase in health complaints of the vaccinated and to put cause and effect in context. In the case of flu vaccines, for example, the CDC has found a possible minimal increase in cases of Guillain-Barré syndrome, a curable neurological disease with symptoms of paralysis.
Post-approval surveillance resulted in the first rotavirus vaccine used in the United States being withdrawn nine months after approval in 1999. Two weeks after vaccination, a few young children suffered from bowel obstruction. Most of the side effects observed with widespread use did not lead to a vaccine being withdrawn from the market, says infectiologist Omer. The application is only restricted to certain groups.
If something goes wrong, the EU pays
Despite all the positive signals, the vaccine manufacturers protect themselves against possible risks. As the “Handelsblatt” reported, the contracts with the pharmaceutical companies contain clauses that compensate the manufacturers for liabilities under “certain and strict conditions”, as the EU Commission expresses it – for example, if a company is liable for damages due to unforeseen side effects . According to the Commission, this is the financial risk that the EU member states are willing to take on for a rapid vaccine.