Mayo Hospital made it clear: This hospital does not have the conditions to store the mRNA new crown vaccine.
Text: Manuscript King Editor: Some parents in Shanxi are familiar with the National Health Commission outside Xizhimen, Beijing.
In 2010, a well-known reporter wrote a famous medical report: Shanxi vaccine case. It is said that nearly 100 children died or became disabled after being vaccinated. The official investigation concluded that:
did not store and transport the vaccine under refrigerated conditions as required.
reportedly reported that the entire container of the vaccine from the local health station was exposed in the yard, and the child was exposed to it. The problem with the sun-dried vaccine. Z2z
Ten years have passed. With a little bit of superficial medical knowledge of the thumb, it is still impossible to believe that the vaccine will kill people or beat people to hemiplegia after being heated. At the end of 2013, Kangtai Biological's hepatitis B vaccine also caused at least 7 infant deaths, which was later attributed to a "coupling reaction" by the State Food and Drug Administration.
If the supervisory authority could extract the word from the medical vocabulary earlier, maybe parents in Shanxi would not have to go to Beijing again and again. Can the
vaccine be used after exposure to the sun? This is a scientific issue, not an emotional issue. The "Chinese Pharmacopoeia" clearly requires that the vaccine be tested for thermal stability. The worst thermal stability is the oral polio vaccine, or "sugar pill", which can remain stable and effective for 48 hours in an environment of 37 degrees. The best performer is the hepatitis B vaccine, which can last for 30 days at 37 degrees.
I dare not say about the quality. In terms of high temperature resistance, our country's vaccine is still reliable.
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A few days ago, Pfizer of the United States released a large satellite and announced that its own agent of the German BioNTech company's mRNA new crown vaccine has achieved phased results, with an effective rate of 90%.
In my country, this vaccine has an interesting name: Fosun's new crown vaccine. At the end of January, BioNTech handed over the development and sales rights of vaccines in China to Fosun Pharma, and all the rights and interests in markets outside of China were given to Pfizer. Now that Pfizer has got good news, of course Fosun can also shine.
It is said that Guo Guangchang, Chairman of Fosun Group, requested that the publicity must emphasize the success of the "Fosun" new crown vaccine, not Pfizer's vaccine.
himself set an example. On November 9th, on his personal public account "Guangchang See the World", Mr. Guo announced to all fans: Fosun's new crown vaccine "R&D partners Pfizer and BioNTech" announced good news.
If you just look at this paragraph, it feels like Pfizer is working for Fosun.
Pfizer and Fosun have never had a cooperative relationship. To say that there is a business connection, it is just that Pfizer sells "Viagra" and other drugs through Sinopharm Holdings, in which Fosun has a stake. Therefore, in foreign countries, Pfizer did not say that "Fosun is our R&D partner", nor did it even mention the word "Fosun".
does clinical trials at no one's speed, but rubbing hot spots is very fast. Fosun lobbied domestic regulatory agencies with Pfizer's "experimental results", stating that it has conducted multiple rounds of communication with the National Drug Approval Center and strives to launch phase II bridging trials in China as soon as possible.
"Bridge test" is a professional concept, and Academician Sang Guowei once wrote a special paper. In layman's terms, it means to allow the use of successful data from foreign clinical trials to cooperate with domestic small-scale trials to prove that drugs can achieve the same effect in different populations.
"Bridged trials" are not enough. Fosun also stated that it hopes to apply for domestic registration based on foreign phase III clinical data.
Since the introduction of this vaccine was negotiated at the end of January this year, Fosun has only completed phase I clinical trials, while domestic Sinopharm, Kexing and other companies are conducting overseas phase III clinical trials of the vaccine. Fosun is most likely to see that it can't catch up with it barefoot, so it thought of using Pfizer's Phase III clinical trial data to apply for approval in China.
Many years ago, foreign-funded pharmaceutical companies privately criticized the domestic drug approval system: FDA has approved it, why should you not approve the CFDA?
But they dare not say it publicly, because they know that the result will be like some pictures posted on the rear window:
Today's Fosun Pharma, without even reminding, directly asks other companies to approve themselves with phase III clinical data "Fosun Covid-19 Vaccine". If this can be negotiated, China's drug approvalI am afraid that history will have to be rewritten again.
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and whether Pfizer is willing to share data with Fosun. Just before Fosun was relieved from the excitement of "90% effectiveness", Pfizer poured a basin of ice water first.
Experts such as Johns Hopkins School of Medicine, Mayo Hospital, etc. have pointed out that mRNA vaccines can only be stored at ultra-low temperatures. They can be stored for 6 months below minus 70 degrees Celsius, and can only be stored at 2-8 degrees Celsius. Keep for 24 hours. What is the concept of
minus 70 degrees? There is a village in the Russian Far East called Oymyakon, which is the coldest place where humans live permanently. Nearly 100 years ago, in 1924, the lowest temperature measured here was minus 71.2 degrees Celsius.
The No. 1 Mayo Hospital in the United States made it clear that this hospital has no conditions to store this mRNA new crown vaccine.
Pfizer seemed embarrassed. The vice president in charge of the supply chain thought of a way: Pfizer was responsible for transporting vaccines from headquarters to hospitals in the United States in a refrigerated truck, and then gave each hospital a cold box with dry ice. Fill it with dry ice, and make sure to open it no more than twice a day. There is no major problem with vaccine storage.”
Pfizer came up with a way to cleanse the mud. What will Fosun do?
The general storage condition of domestic vaccines is 2-8 degrees. After the "Shandong Vaccine Incident" in 2016, various CDCs have equipped small cold storages of 8 to 15 cubic meters to store vaccines. The lowest temperature of this type of cold storage Generally, it is only minus 20 degrees. In addition to cold storage, vaccines also require a full cold chain. At present, the refrigerated trucks deployed by CDCs in various places are generally like this:
and the vaccination storage conditions of each vaccination point are generally like this freezer:
. So after the good news about vaccines, the stock that rose the best was not Fosun Pharma. It is said that it is undertaking the ice wheel environment of Fosun's ultra-low temperature cold storage project:
Even if Fosun gets what it wants, the National Food and Drug Administration approved the "Fosun New Crown Vaccine" based on Pfizer's Phase III clinical data. The hardware cost of the chain will also be extremely high.
Pfizer's "frozen water" was not enough to splash, and then another bowl of ice water was poured out. Pfizer made it clear that the official price of the new crown vaccine sold to the United States is $19.5 each. It is less than 140 yuan.
said a good "global partner", but Pfizer digs a hole for Fosun. What kind of partner is this? In order to win this vaccine, Fosun promised BioNTech a license fee of 85 million euros, including the down payment, clinical development registration and milestone payments for sales, and also promised to pay 35% of the gross profit to the other party.
"Milestone payment" means that Fosun will pay the Germans as soon as the corresponding stage is reached, regardless of whether it is sold or not. And the price of $19.5 is basically the ceiling. "The same new crown vaccine is more expensive in China than in the United States." Fosun dare not recite this reputation.
Fosun Pharma has a net profit of 2.234 billion yuan in 2019. The "Fosun New Crown Vaccine" is really promoted. I am afraid that one year's profit will not be enough to fill this pit. More importantly, Sinopharm’s new crown inactivated vaccine is progressing perfectly and is expected to be approved soon and distributed on a large scale. The products of state-owned enterprises are undoubtedly more advantageous for the new crown vaccine related to the national economy and people's livelihood.
A few days ago, the list of shareholders of the Ant Group was exposed, and many people were unlucky. The good news of the new crown vaccine is just a good news, but I didn’t expect to be in a dilemma now:
wants to promote the vaccine, it has to spend a lot of money to build an ultra-low temperature cold chain, the price of the vaccine cannot be too high, and the gross profit has to be divided by 35%. We have to face the competition with the vaccine of the national prefix. The baby
thought he had picked up, now seems likely to become a thunder.
Of course, money is outside the body.
