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The European Medicines Agency (EMA) has started approval processes for candidate vaccines for AstraZeneca, Pfizer and Moderna. The Norwegian Institute of Public Health claims that one of the vaccine challenges from the previous pandemic has already been solved.
Infection Control Director Geir Bukholm previously warned the Emergency Response Group that one of the lessons from the previous pandemic was that access to syringes and needles can be challenging.
– It was an experience that access to syringes and needles was limited. “We have good control of this today,” Bukholm informs Dagbladet.
The director of infection control arrives with another piece of good news regarding the vaccine candidates for Pfizer and Moderna, which is based on so-called mRNA technology.
– It has been previously reported that mRNA vaccines generally require special needles and syringe tips. This has now been resolved with respect to the current vaccines for Pfizer and Moderna.
Effective
On Monday, AstraZeneca and the University of Oxford declared that their vaccine candidate is up to 90 percent effective depending on the dose. Pfizer and Moderna have previously stated that their vaccine candidates are 95 percent effective.
– All of these vaccines are given in two doses. The AstraZeneca vaccine seems to work best when a slightly lower dose is given first and then a higher dose. It is too early to say why, but it will be investigated when the vaccine manufacturer finally sends more results to the EMA, Norwegian Medicines Agency medical director Steinar Madsen tells Dagbladet.
CORONAVAKSINE: The EMA has started an approval process for three candidate vaccines. Photo: Andrey Rudakov / RDIF / NTB
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Approval
Approval of the candidate vaccine for Pfizer is very imminent in both the United States and the United Kingdom. Recently, the president of the European Commission, Ursula von der Leyen, stated that the candidates for Pfizer and Moderna can be approved by the EMA at the end of December.
Madsen and the Norwegian Medicines Agency also believe that vaccines can arrive faster than previously thought.
– We are very relieved that all three candidates appear to have a high degree of protection and few serious side effects. We are also very happy that these candidates are being tested in such large studios.
– We previously thought that a corona vaccine was likely to be approved in January or February. But now that we have promising results, it can go faster. All of these vaccines will be closely monitored even after we have started the vaccination, so that we can detect any rare side effects.
Main challenge
If a corona vaccine is finally approved for use in Norway and Europe, production and distribution are expected to pose significant challenges in the first period.
Bukholm explains that an advantage of the Pfizer and Moderna mRNA vaccines is that it is relatively easy to produce many doses of vaccine.
– mRNA vaccines represent a new but promising technology. It has many advantages, as it is relatively easy to produce many doses of vaccine. And you can change the vaccine, if changes in the virus indicate so, Bukholm tells Dagbladet, adding:
– The vaccine breaks down quickly when it enters the body, after it has done its “job” of making sure that our own cells produce the vaccine protein and present it to our immune system.
STEINAR MADSEN: Medical Director of the Norwegian Medicines Agency. Photo: Nina Hansen / Dagbladet
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Practical challenges
On the other hand, Bukholm explains, mRNA vaccines should be stored at a lower temperature than viral vector vaccines, such as the AstraZeneca candidate. For example, the Pfizer candidate should be stored and distributed at minus 70 degrees, while the AstraZeneca candidate requires a refrigerator temperature.
– Pfizer vaccine storage and distribution requirements at minus 70 degrees are a practical challenge. We distribute and store such a vaccine in a good way, but it requires careful planning, says Bukholm.
The AstraZeneca candidate should also be much cheaper than the Pfizer and Moderna vaccines. According to CNBC, the Moderna vaccine costs up to $ 37 per dose, the Pfizer vaccine around $ 20 per dose, and the AstraZeneca vaccine up to $ 4 per dose.
A potential corona vaccine will be free to the Norwegian population, but price differences may have an impact on access to the vaccine in other countries.
More candidates
The National Institute of Public Health is still waiting for the results of the phase 3 studies to be available, so they can evaluate the other properties of the vaccines. These evaluations will have an impact on your vaccination recommendations.
Bukholm informs Dagbladet that it may be relevant to recommend more candidate vaccines for use in the Norwegian population and that Norwegians can choose a vaccine.
– Our recommendations will be based on the available documentation on the effect of vaccines. This applies both insofar as they protect against disease, information on the duration of immunity, insofar as it exists, and information on side effects. There can also be different effects in different age groups and the like, says Bukholm and continues:
– The NIPH will make a general evaluation of the properties of the vaccines and will give recommendations on which vaccine or vaccines we think will be the best options. It is important that these evaluations are open and transparent so that the population knows the history of the evaluations and can possibly choose between vaccines, if more vaccines are recommended.
