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What really happened? It’s a breakthrough?
Pfizer and German biotech company BioNTech arrived with great news Monday. They then said they had seen very encouraging results from their corona vaccine in trial phase three. The final phase of the study assesses how well the vaccine protects against infection. Details on this are currently scarce, but there is still positive news.
What was the results?
Pfizer and BioNTech have analyzed 94 cases in which participants who had received two doses of the vaccine or a placebo had been infected with the coronavirus. In these cases, the vaccine was 90 percent effective seven days after the participants had received the second dose. Because the vaccines are taken three weeks apart, the researchers believe that the vaccine provides protection against the virus 28 days after the first injection.
How long until we have a vaccine?
More than 170 research teams are participating in the race to develop a safe and effective vaccine:
- 155 vaccines are in the preclinical phase, which means that they are not tested in humans
- 39 vaccines are in phase one involving small controlled trials
- 18 vaccines are in phase two, meaning they are tested in a slightly larger group, often these studies have around 1000 participants
- 11 vaccines are in phase three, where they are tested in large groups of patients. This is the phase that the Pfizer and BioNTech vaccine is in.
Pfizer has not seen any risks from taking the vaccine. In Monday’s statement, they emphasized that the study participants were of different backgrounds, which is important since black and ethnic minorities appear to be at higher risk of developing serious diseases.
Drug regulatory authorities have previously said they will green light vaccines that are at least 50 percent effective. This is well below the results of the Pfizer vaccine.
How does the vaccine work?
Pfizer’s vaccine is based on mRNA, a genetic material that makes it possible to produce the spiky proteins found on the outside of the coronavirus. When this vaccine is given, a small dose of this genetic material is injected. This causes the body to produce antibodies, and also activates other immune system responses that protect against the virus.
How excited should we be?
Most experts agree that Pfizer’s results are encouraging and exciting, but there is a small danger of optimism – these are the first results that have only been announced in a press release. This study is not finished yet either.
So far, 38,955 participants have received two doses of the vaccine, and the researchers plan to re-evaluate the results when 164 of the participants are confirmed to be infected with SARS-CoV-2. They should also follow participants for two years after vaccination to investigate whether the vaccine is still safe and whether it still protects against infection.
There are also many things that we have not yet received an answer to, how long does the vaccine protect? Does it protect people who have been infected in the past? Does it prevent people from getting infected and infect others, or does it only reduce the symptoms of a possible infection?
There are also challenges related to logistics. The vaccine should be stored at a temperature of minus 80 degrees. Distributing it can be challenging, even for developed countries.
The results are still very encouraging. What makes it even more successful is that this may be the first mRNA-developed vaccine. This may be the starting point for the development of new vaccines against other diseases. If it is successful, it will also set a new record in the shortest development time for a new vaccine.
Read also: Biden: Vaccine news gives hope, but there is still a long way to go
How fast will it be available?
There is a little way to go before the vaccine is available. Pfizer plans to seek approval from the US Food and Drug Administration as soon as they have enough data to show that the vaccine is safe, perhaps as early as the last week of November.
Norway has joined the EU program for corona vaccines and will therefore receive the vaccines at the same time as EU countries through an agreement with Sweden. This also applies to the Pfizer and BioNTech vaccine.
The logistical challenges we have faced in the past, such as the fact that they must be stored very cold, can make it difficult to distribute the vaccine, especially in countries with poor infrastructure.
Although the manufacturer takes into account the high demand and mass production, the question remains who should get the vaccine first. And how to get mass vaccination?
And the other vaccines? Why is the Oxford vaccine so late?
There are more than 170 vaccines in development, of which 11 are in phase three, including the much-touted Oxford vaccine and the mRNA vaccine from the American biotech company Modena. The Oxford and AstraZeneca vaccine was developed by taking the enriched protein and modifying it with a chimpanzee cold virus that cannot spread and cause infection.
The results of the Oxford study are expected in a few weeks.
Translated and edited by Kathleen Buer / ABC News / © Guardian News & Media Limited
