Moderna CEO “Teenagers should not be vaccinated as safety unconfirmed”
Last week, the footage of my local ICU was posted on the internet. I have passed by the hospital almost daily and now it’s treating the severe cases of Covid-19 patients. The footage showed the ICU was already beyond the full capacity. The beds were lined up in the hall and the patients were breathing oxygen on the bench. The comment said the doctors didn’t even have a moment to drink water from the morning.
On the other hand, my neighboring school has cars coming to the parking lot. They are open and students come everyday. Surely the schools are prohibited to teach in person as the President had a speech last week. However this school found a way to connect before school and after school to keep it open like an ordinary occasion. While the ICU doctors are risking their own lives, some institutions are producing the new patients restlessly.
Vaccine is one of the reasons for these behaviors. However if we really had a decent education at school, we can find the sobering facts about what we call vaccines.
On 23rd November, AstraZeneca and Oxford announced that their vaccine had 70% efficacy, based on a study of the first 131 cases of Covid-19 in the trials in the United Kingdom and Brazil. After this announcement, they took down this trial result and decided to implement the worldwide safety trial again. In the safety trial that their 70% efficacy was based on, only half the amount of the vaccine was mistakenly dosed on some volunteers and they showed better protection against Covid-19. While the group that had the designed dose of the vaccine showed 62% efficacy, the half-dosed group showed 90% of efficacy. They picked the number of 70% between 62% and 90% efficacy. The reason why half the amount of the vaccine showed the better result hasn’t been identified but reportedly this group did not include any volunteers over 55 years old. Either way, the new safety trial must be implemented again with the perfectly managed conditions.
On 9th November, New York-based Pfizer and the German company BioNTech announced their vaccine resulted in 95% efficacy after the final safety trial. Their vaccine is based on the new technology called mRNA vaccine, which has been believed to be a technical challenge. mRNA vaccine doesn’t require the actual virus sample to make the engineering significantly easy. On the other hand, it is known to cause immunological adverse reactions especially after the second shot. According to the announcement of Pfizer, the result of their vaccine was evaluated only 7 days after the second shot to the volunteers. It was 28 days after the first shot. They announced the efficacy of the vaccine but the safety had been observed only for 1 week. Besides, they haven’t announced how many volunteers got infected in the final week in the placebo group so we do not know if 95% efficacy was due to the first shot or if the second shot also contributed to the result. Pfizer described the adverse reactions to be only mild, however numbers of the volunteers reported the severe illness soon after the shot. The premise of vaccine trial is that no volunteers nor doctors can distinguish the vaccine and placebo. If the ill volunteers stayed home due to the adverse reactions, they were less likely to be infected regardless of the efficacy of the vaccine. On 1st December, European regulators pushed back formal assessments on their vaccine and it became less likely to be distributed before next year. The European Medicines Agency said it planned to give an opinion on 29th December.
The Boston-based company Moderna announced 94.1% of efficacy of their vaccine on 16th November. Their vaccine is also based on the technology mRNA. mRNA vaccine had been believed to be a technical bar for years but 2 mRNA vaccines suddenly appeared this Autumn. Moderna split 30,000 volunteers and observed 11 infections in the vaccinated group while 185 volunteers were infected in the placebo group. This is simple math for the safety evaluation of the cutting edge technology. According to their website, Moderna completed the enrollment of the volunteers for the phase 3 trial on 22th October. The detailed process of the implementation is not clear, but the efficacy result was announced only 3 weeks after the vaccination. If their vaccine needs a 3 weeks interval between the first and the second shot like Pfizer’s, they announced the result on the day of the second shot or even before the second shot. Moderna was required to wait for at least 1% of the volunteers to be infected in the placebo group. The placebo volunteers were infected sooner than estimated and one third showed severe symptoms and one of them died. It was possible that Moderna could not wait to shut down the trial anymore. Either way, the chances to observe the adverse reactions of the first mRNA vaccines were gone. On 1st December, European regulators pushed back the formal assessment of Moderna’s vaccine as well. It is planned to give an opinion on 12th January.
On 30th November, the CEO of Moderna spoke on Bloomberg TV. He said “Teenagers should not have the vaccine as the safety isn’t confirmed yet.”