Pfizer and BioNTech’s corona vaccine is one step further towards approval for emergency use in the United States. The FDA has released a report on the vaccine. This shows that the vaccine does indeed work well and is safe. Together with the report on the UK approval, this provides a lot of new information.
The British regulator MHRA has already approved the Pfizer vaccine. The vaccine is already being administered there. The FDA will likely approve it sometime in the coming weeks. The European EMA expects to be able to put a stamp on it in January. The Netherlands has also bought half a million Pfizer/BioNTech vaccines and will start vaccinating in January if all goes well.
1. These are the side effects
The most commonly reported side effects are:
- Pain at the puncture site (>80 percent)
- Fatigue (>60 percent)
- Headache (>50 percent)
- Muscle pain (>30 percent)
- Chills (>30 percent)
- Joint pain (>20 percent)
- Fever (>10 percent
2. Fewer side effects in the elderly
Special: the vaccine had fewer (and milder) side effects in the participants who were older than 56 years than in younger participants. The side effects were generally mild and resolved after a few days. With such a large group of test subjects (44,000 people), there are of course always people who suffer something serious or who die. But the proportion was similar in the vaccine group to the placebo group (people who were given saline, rather than the vaccine).
3. Not for everyone
The study has no fewer than 44,000 participants, but that was not enough to provide all population groups with a safe vaccine. The vaccine has not yet been proven to be effective and safe in children under 16 years of age, pregnant women, and people with a weakened immune system.
The British registration authority has further advised against the vaccine for people on anticoagulant drugs, or bleeding disorders. This is because an injection into the muscle can cause bleeding problems. This risk must be weighed against the risk of COVID, the MHRA writes.
4. A single inoculation may already work
The vaccine must be given twice. Only then does it offer maximum protection against COVID. But a single vaccine was already effective for roughly half of the people, the new file shows. After the first vaccine, protection has already started in 52 percent of people. Further research is now being done on this.
5. Only really effective a week after the second injection
You are not protected against COVID immediately after the injection. The body takes some time to make antibodies and white blood cells that protect against the coronavirus. Seven days after the second vaccine, most people succeeded, then 95 percent are protected. Good to know:
This is calculated based on the fact that 8 people in the vaccine group had received COVID and 162 people in the placebo group. Small numbers still, we don’t know everything yet, but high effectiveness. A month after the second dose, the immunity really picks up: the amount of antibodies is then comparable to that of people who have had COVID.
6. Probably also useful after corona
People who have already been ill with the coronavirus probably also benefit from vaccination. But this conclusion was drawn on the basis of very few test subjects, so this is far from certain. It is not yet possible to say whether the vaccine also works in people who currently have COVID.