Corona vaccine: EMA recommends approval – health

This Monday, the European Medicines Agency (EMA) opened the way for the approval of the first vaccine against the new coronavirus in the EU, now the EU Commission will have to make a decision in the coming days. If all goes according to plan, the first people in Germany could be immunized against the pathogen with a syringe on December 27. The most important questions and answers.

What type of vaccine should be approved now?

BNT162b2 is a so-called mRNA vaccine developed and manufactured by the Biontech / Pfizer company. In the body, mRNA normally represents a biological messenger between DNA in genetic material and protein factories that convert genetic blueprints into biomolecules. According to the instructions in the mRNA of the injected vaccine, a protein is produced, a part of the virus that serves as a warning shot for the immune system. In case of infection, it recognizes the pathogen more quickly and can eliminate it before the vaccinated person becomes ill. The mRNA is not incorporated into the human genome, but rather it breaks down very quickly. This vaccine is given in two doses approximately three weeks apart.

How well is this protected against infection?

It is not yet clear. However, based on current data, it is certain that this vaccine protects very well against disease. The effectiveness is 95 percent, in broad age groups and in different ethnic groups. There are also indications that the vaccine ensures a gentler course in the rare case of illness. However, so far there is a lack of data on the question of whether people who have been vaccinated can spread the virus even if they do not get sick. Many experts doubt that “sterile immunity” can be established with mRNA vaccines, but initial data indicates that vaccinated at least shed less virus than unvaccinated.

Who can get vaccinated first?

Under the federal immunization ordinance, people over the age of 80 and residents of nursing homes must be vaccinated first, as well as medical personnel, for example, in emergency rooms or crown rooms and in the care of the elderly . The EMA recommends approval for people who are at least 16 years old.

How much vaccine does Germany receive?

Initially there should be around 400,000 cans of BNT162b2. According to the Federal Ministry of Health, three to four million doses could be available in January. In the first quarter, the ministry expects between 11 and 13 million doses of vaccines.

Do vaccinated people still have to wear a mask?

Both the now-approved Biontech / Pfizer vaccine and Moderna’s, which is expected to follow soon, are unlikely to create completely sterile immunity, meaning that people who have been vaccinated can still transmit the pathogen, although likely in smaller amounts. It is known from animal experiments that vaccinated monkeys do not get sick if they are infected with Sars-CoV-2, but that they still have live viruses in their noses that they can spread. For this reason, vaccinated persons cannot be released from the obligation to wear a mask and must not dispense with it for their own protection. They must also respect the rules of distance and hygiene and ventilate regularly. The first two vaccines are extremely effective, but no one is guaranteed to be protected. It is not yet clear to what extent future vaccines will guarantee sterile immunity.

Are there any known side effects?

Clinical studies have shown that mRNA vaccines stimulate the immune system to such an extent that some people experience marked vaccination reactions. In many cases they are described as short but fierce. It starts with a swollen arm, cold symptoms may appear, but also chills and fever. Up to five percent of the subjects in the approval studies had temporary severe symptoms, so some experts recommend not scheduling important appointments in the days after the two vaccinations. The body sometimes reacts violently to flu shots and other immunizations. Thirty percent of trial participants who were not vaccinated with the corona vaccine but with a placebo in clinical studies also complained of such reactions to the vaccine. In the vaccination group, some people reported swollen lymph nodes and a very small number reported paralyzed facial nerves, although in the latter case the connection to vaccination is unclear. By the weekend, the Biontech-Pfizer vaccine had been injected more than 270,000 times in the United States. Serious allergic reactions occurred in six cases. People who have had an allergic reaction to a vaccine should definitely inform their doctor. If many people get vaccinated, the likelihood of serious side effects increases in individual cases. Therefore, the tolerability of vaccines will continue to be monitored even after approval. Experts emphasize that the actual risk of infection must be weighed against the theoretical risks of vaccination. About one in every 100 infected people dies from the virus; about two out of every hundred need intensive care.

Could complications arise a few years after vaccination?

Real long-term experiences cannot be made just four months after the first administration of the vaccine to a larger group of test persons. The health of the participants must be monitored for two years. In the past, documented rare damage from the vaccine generally occurred fairly soon after vaccination and not decades later. However, the fact that there is no long-term experience with mRNA vaccines, as is often claimed, is not correct: vaccines of this type have been tested against other infectious diseases in humans for more than five years and these studies have shown to be very tolerable.

How are side effects and long-term effects managed?

“Side effects of vaccines are rare, but can never be completely ruled out,” says the Federal Ministry of Health. Therefore, when introducing new Covid-19 vaccines, “active monitoring of the effectiveness and safety of vaccines is absolutely essential.” At the Paul-Ehrlich-Institut, vaccination complications can be submitted directly via the Nebenektiven.bund.de website. Anyone can use the form if they suspect a connection to vaccination. Doctors, pharmacists and companies are required to report. Federal Minister of Health Jens Spahn announced that the side effects will soon also be broadcast via a dedicated app.

Is there a central documentation of those vaccinated?

According to the Federal Ministry of Health, non-personal data is used to monitor the vaccination rate in the population. To this end, the Robert Koch Institute specially developed a system that will be used both in vaccination centers and in mobile teams.

Who gets what vaccine?

Following the Biontech Pfizer vaccine, the next vaccine approval by the EMA is expected in January, and more vaccines could be available in a few months. The Robert Koch Institute’s Standing Commission on Immunization will develop recommendations on which vaccines are particularly suitable for which groups of people.

Should people who have already had Sars-CoV-2 infection get vaccinated?

People who have been previously infected have very different amounts of antibodies in their blood that can protect them from a new infection. It is also unclear how long this protection will last. For this reason, many experts believe that sick people should also be vaccinated. “Previous vaccines produce a very strong antibody response that can last longer than that caused by an infection,” says Eleanor Riley, professor of immunology and infectious diseases at the University of Edinburgh. It is also logistically impossible to test everyone for antibodies prior to vaccination. “It is much easier, faster, cheaper and less risky when everyone is vaccinated.” Robert Koch Institute President Lothar Wieler also declined a pre-vaccination antibody test in mid-December to put already infected people on the back burner. According to previous knowledge, less than ten percent of the population, including the number of unreported cases, has been infected with the corona virus.

Will there be mandatory vaccination?

No. Until now, the federal government has clearly ruled out a general immunization requirement.