Tochazo incoming... pero
interesante relato de un pavo detras de la banderilla de Pfizer. De aquí:
Svensk bakom vaccinet: Strutsmentalitet i Sverige | SvD
Swedish behind the vaccine: Ostrich mentality in Sweden
He is the Swede behind Pfizer's corona vaccine, which became world news. For SvD, head of research Mikael Dolsten tells about feverish activity behind the scenes, the meeting with Donald Trump and how the pharmaceutical giant got its vaccine candidate.
A leaf blower clears autumn leaves from the tennis court next door. Pfizer's global head of research sometimes plays, but has to force himself into leisure activities.
- It becomes easy when your work is a passion. It is difficult to tear yourself away, he says.
Since March, Dolsten, who was born in Halmstad and began his career as a doctor and researcher in Lund, has been busy with the most important project of his career: to develop a vaccine against the cobi19. It is here, from the villa in the burgh villa suburb forty-five minutes drive north of Manhattan, that he leads the work.
Monday's world news that Pfizer's vaccine proved to have a 90 percent effect lifted the stock market and raised hopes but also questions. What exactly does 90 percent effect miccionan? What remains before the US Food and Drug Administration can urgently approve the substance? Is it as safe as the company claims or research remains?
The news gave flashes of light in a gloomy situation. Every day, about 1,000 Americans die from the bichito, and over 100,000 test positive. In Europe, whole countries are shutting down. In Sweden, a ban on alcohol serving after 10 pm and most regions face their own restrictions.
For Mikael Dolsten, the journey to Monday's announcement has been challenging both privately and professionally.
In March, his wife, Catarina, contracted the bichito. She was hospitalized in New York City, but has today largely recovered.
- Unfortunately, I learned about the disease from two directions. From the inside out by being close to my wife and discussing treatment, and by amowing the research. It was a scary feeling and at the same time fascinating to feel that we could contribute something.
This spring, he temporarily moved to New York City to be close to his wife, who is a doctor and organizational consultant, at the hospital. He remembers the paralyzed city, the overcrowded hospitals, the military ship with extra sickbeds moored on the west side of Manhattan. But also the confidence of New Yorkers. How they went out on their fire ladders and balconies every day at seven in the evening and rattled with a spoon and pot in honor of the medical staff.
Behind the scenes, feverish activity was going on. The world pharmaceutical company competed to develop vaccines and medicines but groped in the dark.
Mikael Dolsten remembers Sunday the first of March as decisive. He was in Washington DC to prepare for a meeting in the White House that President Donald Trump, pressured by the growing viral numbers and the ongoing election campaign, invited to on Monday. Pfizer was working on a el bichito treatment, but not a vaccine program. Many employees were skeptical about developing one. Earlier vaccines, such as the one against SARS in 2003, had been completed when the epidemics were overblown.
- I returned to the idea that this seemed different. It looked like a pandemic that had not occurred since the Spanish flu in 1918, he says.
Pfizer's CEO Albert Bourla's words were also in mind that the company had the opportunity to take a leading position in the fight against the bichito.
Dolsten called the head of vaccine research, Kathrin Jansen, and asked her to call Ugur Sahin, CEO and co-founder of Biontech. Pfizer had previously collaborated with the German pharmaceutical company.
- I said: The question is whether this must not be seen as the greatest cure in 100 years? We must ask the Germans if they want to cooperate. She called back and said that "the Germans are probably very open".
The next day he found himself in the White House.
Vice President Mike Pence greeted with his elbow, President Donald Trump shook hands. Around the table also sat Dr. Fauci and representatives of seven other pharmaceutical companies.
- I focused on what we already had going on, but with the tone that we also see the opportunity to look at a vaccine with a new technology. It was a constructive meeting where everyone said: Let's work in a new way. Let us be transparent and publish as soon as we can, so that we learn from each other and let us help each other if possible, even if we are different business companies.
An anxiety still spread within him.
- I realized that if none of us can develop a treatment, it was unlikely that anyone in the world would be able to. No one had more resources or experience. When I analyzed the others in the room, I also realized that Pfizer had the most experience. We have been using vaccines for a hundred years.
Mikael Dolsten contacted the CEO Albert Bourla.
- He was brave and said we should go all in, he remembers.
The chance that amowed cost Pfizer over a billion dollars in research and production.
The project was named after the speed of light. A reference to the urgent matter but also the competitors' lead. A number of strategic decisions were made in Operation Lightspeed. The first was not to receive money from the US government, as it risked delaying the process.
- We were a month behind but worked very organized. We were able to move forward faster with a faster decision-making process, says Mikael Dolsten.
Pfizer and partner Biontech began work on four different vaccine candidates that had been reduced to two in July.
Most companies chose to start only from the nail protein on the bichito, but Pfizer initially chose another path: to try to start from the tip of it, called RBD, which dockes against the airways and helps the bichito get into the cells. Such a vaccine had been tested on hundreds of volunteers in the early studies. The next product candidate was the whole nail protein, but had not been tested on as many individuals.
The vaccine candidates that had been developed were synthetic, so-called mRNA vaccines. A new and promising but still rare technology.
In mid-summer, Pfizer faced a crossroads. The company needed to choose a vaccine candidate.
Dolsten and Bourla and co-workers made an unconventional decision.
- We opted out of the vaccine candidate who had come the furthest and chose the one with much less data. It was a bit grand as putting together a puzzle. We had almost a whole puzzle with the first candidate but we also saw that it gave more side effects. The sequel seemed to be better tolerated by the subjects and we started to see nice immune-protective effects.
The first candidate gave side effects in the form of fever, headache, pain and redness. The other seemed milder and gave a good immune response against the nail protein.
But internally there were objections, says Dolsten.
- It was very tough. I remember there were some who thought we should keep the gas at the bottom of the first candidate.
The large registration studies started with 30,000 people, mainly in the USA and South America. Half received active substance and half placebo. Pfizer did not know who belonged to which group. Only a handful of experts had access to the figures and were tasked with flagging whether the study needed to be suspended for security reasons. No such message came.
The study was expanded to more than 40,000 individuals by including more sensitive individuals: HIV- and hepatitis-positive, and finally young people under 12 years of age.
In order for the study to be fully evaluated, a critical number of subjects were required to suffer from el bichito-19. When the pandemic accelerated, it was faster to get up to the disease rates that were in demand.
Recently, the study reached around 44,000 subjects and reached 94 cases. This made it ready to be evaluated for the first time.
On Sunday, November 8, the day after several television stations named Joe Biden the next president of the United States, Pfizer's top executives were summoned to a meeting. Five people in mouth guards around a conference table. Dolsten, Bourla, the communications manager, a company lawyer and another employee who attended via link.
The US Data Monitoring Committee would announce the results. One billion dollars and eight months of work were at stake.
- What if it does not work? What do we communicate to those who feel antiestéticar? If our vaccine did not work, others probably would not either. Then we were maybe two years away from finding something again.
Dolsten recounts the meeting in Connecticut, where several top executives live. Shortly before the video link started, Albert Bourla turned to him and asked:
- What do you think will be the vaccine effect?
Dolsten, trained in resisting bias as a result of wishful thinking, leaned towards his experience.
- Some vaccines have been up to 90 percent, but this is quite complicated. Keep your fingers crossed, maybe it's 70 percent? But I do not know, it can fail.
Mikeal Dolsten describes the moment when they hit the video call as the most nervous in his professional life.
The experts on the video link kept the group on edge. Cold-spoken before communicating the news: The study was positive and showed a statistically beneficial vaccine effect. Then came the even better detail:
The Data Monitoring Committee has told us that they want you to apply as soon as possible to have the vaccine ready for registration. Your effect was over 90 percent. ”
- We jumped up from the chairs. My God, it's unbelievable. It’s unbelievable. It felt like the heart was jumping out of my chest. Sunday is the only time I have not been able to sleep at night.
During the week, Mikael Dolsten reproduced the reaction in an interview with the American television station CBS. Comedian Trevor Noah then played the clip on The Daily Show.
- A colleague who likes him had seen it. Noah thought my accent was reminiscent of a real scientist, he laughs.
But the message has also been fraught with political controversy. Donald Trump, whose failures during the pandemic contributed to the loss of the election, accuses Pfizer of delaying the message with the FDA and Democrats to snatch him an election victory. A antiestéticar he had already before the election, when he flagged that a vaccine would come shortly after that. The timing may seem suspicious. Is there something in the president's criticism?
Mikael Dolsten shakes his head.
- We never take a political position. We work with the speed of research, he says.
However, the visit to the White House, although not Donald Trump personally, had an impact on him.
- There was a certain historical spirit when you entered the cabinet room where the US government meets. It instilled a feeling that "we have to think bigger".
At the moment, there is still an "emergency use authorization", an approval for emergency use, by the US Food and Drug Administration. Then logistical challenges. The US military has promised help distributing the vaccine in the United States.
Mikael Dolsten believes that an approval can take place within a couple of weeks.
At the same time, it is expected that it will take time before details about the vaccine are sorted out. He asks questions himself.
- How will it be in the future? Vaccination every year or every five or once in a lifetime? No one really knows how long the immunity lasts, but I would think that it is most likely that you need to be vaccinated every few years.
My mother, like your wife, has had el bichito and still has long-term symptoms in the suites of the bichito. Should those who have had the bichito also take the vaccine?
- In general, it is likely that those who have been ill will become sensitive again after maybe a year. Until now, quite a few have been seen getting the bichito again. After two years, you may have as great a risk as everyone else. I would think that for your mother or my wife, that after one to two years one approaches the time when a vaccination would be very helpful. We will know more about this in the future.
Another problem is that the bichito can mutate. Twelve people in Denmark, for example, have been infected with a variant of el bichito-19 that has mutated in minks. All minks in the country were killed after the discovery and Prime Minister Mette Frederiksen warned during a press conference that the new bichito could render the vaccines that are now being developed ineffective.
Mikael Dolsten does not want to go that far.
- We have to amow the bichito. It is likely that within five years so much has changed that we need to upgrade the vaccine. What is unique about this mRNA vaccine is that it is synthetic and that we can upgrade it in a few weeks.
But Mikael Dolsten thinks we may need to get used to pandemics.
- It is not unlikely that we will get a new corona pandemic in seven to eight years, he says.
When can we return to normal in the sense of going to football and concerts?
- I would think that we will have up to 50 million vaccine doses this year and at least 1.3 billion doses next year. There may be more if we can expand production. It also depends on how many others succeed, but within a year we should be able to return to a much more normal life and in another year later we should be able to declare victory over the bichito war. But we must be prepared for it to flare up again.
Who do you recommend should get the vaccine first?
- As a doctor, it seems reasonable to give it to those who have been heroes in the hospital and still live at great risk: nurses, doctors, health care assistants, police, firefighters, those who run grocery stores and those who are at high risk of becoming ill, as elderly people in nursing homes and those with chronic illnesses. Later in 2021, we must try to take the entire population in a fair way. It is each country's infection control authorities that decide on this.
Half a billion doses have already been ordered from, among others, the USA, Japan and the EU. What are your priorities and loyalties, are they the ones who are worst affected or those with the most money who get to buy first?
- We try to spread it in a fair way. The countries that get involved and negotiate are the ones that get it first. We are also trying to build relationships with organizations that can help distribute vaccines to developing countries. Like the Gates Foundation and the WHO. It is my goal that it should not just go to the countries that can pay high prices. It is important for the relationship between research and representatives of the whole world. I think this is an example of how we as a pharmaceutical company take enormous risks ourselves. Had we not had a positive result on Sunday, we would have lost more than a billion dollars.
You're talking about poor countries. Many of them are also warmer countries and the vaccine should be stored in minus 80 degrees Celsius. How do you see the challenge and criticism that is raised around this?
- It is a very good question. We saw an opportunity to get a vaccine quickly and noticed that the fastest way was to transport the vaccine via refrigerators and we have developed a system for that: a large box that we fill with dry ice. If you do not have ultra-cold freezers, the vaccine can be stored in the boxes for two weeks. In the refrigerator it lasts for five days. We are also working on turning the liquid into a freeze-dried powder. The plan is to have it ready by the second half of 2021. Then you can probably keep the vaccine in ordinary refrigerators.
How is the powder converted into a liquid?
- For example, you may have a tube from which you can extract five doses. Then you fill with a sterile saline in a syringe and then you can inject.
For this is a problem even in a country like the United States, that not all hospitals are equipped with ultra-cold refrigerators?
- The US Army has offered us to help with logistics. One of their generals has worked with us. But almost all university hospitals have the coolers required. We will work with logistics experts in each country for nine to twelve months before we hopefully switch to the freeze-dried powder.
There is a great deal of vaccination skepticism. Do you understand that people are worried considering that the vaccine was developed so quickly?
- Yes, there has been a debate that speed must not compromise on quality. We were some of the first to say that we will not apply for approval and distribute vaccines without major studies, as Russia and China have done, under no circumstances. I think that vaccination resistance is about a antiestéticar of something you do not fully understand and have knowledge of. You do not think you have control and there is a lot of emotion in it.
It's basically about attitude, he thinks. To want to protect others as much as oneself.
- You increase the risk of others being infected and spreading the disease. Without vaccination we would not be able to return to a normal life. Everything has risks. There are risks with eating red meat and smoking and on that scale vaccines are much better because we have a proven benefit and a risk that is low. Maybe one in 10,000 can get a side effect while the other 9,999 do not get any at all.
Can there be so many people who do not take a vaccine that it affects the braking of infection?
- Absolutely. Especially if you focus on certain neighborhoods and areas. I believe that one must have a long-term commitment to the benefits of various medical interventions. The difference between a vaccine is that you have to keep in mind that you have a responsibility to other people.
Here in New York, there is a great deal of solidarity in wearing mouth guards to protect others. Sweden has a completely different strategy. How do you look at it?
- There are so many studies that show that mouth protection is the easiest and cheapest way to protect above all others. I have a bit of a hard time understanding why people in Sweden do not use that form of simple protection. I think the second is that the strategy in Sweden is very dominated by individuals. It is very important to have a larger group and not just a person who is heard. Then you reduce the risk of what is called "stork bias", ostrich mentality. The ostrich sticks its head down and does not see that the whole world is different.
Sweden has relied too much on Anders Tegnell?
- You have had a single person who has been dominant. Then you get a lot of ostrich mentality. It is not the case that you know best in Sweden or the USA or Germany. You learn together. I think it is important not to isolate oneself and not to assume that what was said at the beginning will be right at the end.
