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Work on the distribution of the COVID-19 experimental vaccine, developed by Pfizer Inc and BioNTech SE, is gaining momentum after the companies announced successful interim data on Monday. But the vaccines will soon not appear in local pharmacies for mass use, Reuters reports.
It may take at least a year for us to enter mass vaccination, there is currently a shortage of vial transport and storage equipment and many countries do not have the capacity to produce on their own territory with the unusual technology used.
Data that spiked US stock prices to record levels showed that the two companies’ experimental vaccine was 90% effective in preventing COVID-19. They are still awaiting information on the safety of those vaccinated, which may be announced later this month.
Wall Street stocks fell on Thursday, including due to awareness of when the vaccines will hit the market. This happened on the eighth day in a row with more than 100,000 Americans infected.
Pfizer and BioNTech must persuade regulators to grant permission before they can begin delivering vaccines to those authorities deem most in need. Healthcare professionals and those living in nursing homes are likely to top this list.
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- How BNT162b2 works
- The development of a vaccine called BNT162b2 is based on RNA information technology (mRNA), which uses a chemical agent to “instruct” cells to produce proteins that mimic the outer surface of the new coronavirus, thus creating immunity. After injection into a muscle, the mRNA is taken up by cells, with ribosomes, called cellular protein factories, reading the instructions and creating the “coronavirus protein” in question. It then spreads throughout the body and the immunization process is the same as with other vaccines: the immune system recognizes the proteins produced as foreign and produces antibodies against them.
- The mRNA is based on synthetic genes that can be generated and produced in a matter of weeks and are produced in large quantities faster than conventional vaccines; Pfizer and BioNTech have already collaborated to develop mRNA-based influenza vaccines.
But the complex requirements for the vaccine to be stored and transported at very low temperatures are a stumbling block for even the most modern hospitals and can affect when and where it will be available in rural or poor countries where resources are limited.
The main problem is that the vaccine, which is based on a new technology that uses synthetic RNA to activate the immune system against the virus, must be kept at least 70 degrees Celsius.
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“The so-called cold chain will be one of the most challenging aspects of supplying this vaccine,” said Amesh Adalya, principal investigator at the Johns Hopkins University Center for Health Security. “It will be a challenge in any case, because hospitals, even in large cities, do not have vaccine storage facilities at this ultra-low temperature.”
The new technology has not yet been approved for any vaccine.
In fact, one of America’s most prestigious hospitals, the Mayo Clinic in Rochester, Minnesota, said there is no such opportunity at the moment. “We are talking about a vaccine that needs to be stored at minus 70 or 80 degrees. This is a huge logistical problem not only in the United States but also outside the Western world,” said Dr. Gregory Poland, virologist and vaccine researcher at Mayo Clinic. “We are an important medical center and we do not have that storage capacity. This will be valid for everyone. This is a logistical obstacle.”
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Pfizer spokeswoman Kim Benker said the company is working closely with the US government and government officials on how to deliver the vaccine from its distribution centers in the United States, Germany and Belgium throughout. the world. The detailed plan includes the use of so-called dry ice (the popular name for the solid state of carbon dioxide) to transport frozen vaccine packages for up to 10 days by air and drought at recommended temperatures, he said.
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The Conversation recalls that Monday’s news is about the so-called intermediate analysis of whether the vaccine works. The data cited is from just 94 infected volunteers who underwent development and then continue their normal lives, but their condition is monitored regularly. The tests were not completed before there was data from at least 164 people infected with the Pfizer vaccine, that is. efficiency is likely to improve or deteriorate. The volunteers must then be monitored for side effects.
State and local health care providers are responsible for storing and administering vaccines once they have been delivered. They can be kept in an ultra-low freezer for up to six months or five days at 2-8 degrees in the form of a refrigerator, which is generally available in hospitals, Benker said. Pfizer’s storage devices can also be recharged with ice for up to 15 days, he said.
But the vials will spoil in about five days at normal cooling temperatures just above freezing. BioNTech CEO Ur Sahin told Reuters that the companies were analyzing whether they could extend this by two weeks.
The Moderna Inc vaccine, which is powered by a vaccine based on such technology, does not need to be stored at such a low temperature. Other vaccines, including those from Johnson & Johnson and Novavax Inc., can be stored at 2-8 degrees C, the temperature of a common refrigerator.
The cost to the United States (and developed countries) is $ 39 for vaccination (probably) in two doses.
Northwell Health, a large New York hospital system, is expanding its ultra-low temperature storage capacity. Although it’s possible to use the vaccine before it breaks down, Northwell Chief Pharmaceutical Officer Onisis Stephas said the hospital has decided that the freezer equipment will ensure the vaccines run smoothly.
Cold storage requirements could hamper Pfizer’s ability to reach rural healthcare systems and nursing homes, or less affluent countries that may not have the funds for refrigerators, experts say.
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“If Pfizer’s has the only vaccine that will be allowed in the next few months, we are concerned about the fairness of its spread in rural areas,” said Claire Hanan, executive director of the Association of Immunization Managers, a lobbying organization for local public health officials who handle vaccines.
Supplies in this category of freezers are already limited because hospitals are already competing for them, Stefas said. Some states have declared to the US Centers for Disease Control that there is a shortage of freezers that are too cold and are asking the Trump administration for additional funding, documents show. In California, about half of health services are looking to buy or rent refrigerated storage. The state proposes to build a distribution network of ultra-cold freezers, including mobile vaccination clinics, to reach underserved areas. California has said it will not provide vaccines for facilities that do not have adequate refrigerated storage facilities.
Without additional equipment, clinicians will find themselves in a dilemma: store vaccines in standard refrigerators and place all 975 doses in each Pfizer vaccine container in less than five days, or fill them with dry ice and open only twice a day to extend the Vaccine life, Hanan said.
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What else is known about the vaccine?
– Pfizer expects that in the coming weeks it will request permission for mass and emergency use in the United States of
the vaccine for people from 16 to 85 years old
– for this purpose you should collect security monitoring data from about half of the approximately 44,000 participantsand in the two-month study (scheduled for late November); the FDA regulator granted the vaccine “accelerated” status in mid-July; The EU drug regulator said on Monday it had not yet received results. large-scale vaccine testing
– BioNTech CEO Uur Sahin said he was optimistic. the immunization effect of the vaccine should last for one year, although I’m not quite sure; so far the data is about 3 months
– There are questions about effectiveness in different demographic groups, in the first phase there was evidence that it was weaker in adults
– Health experts have warned that It may take 12 to 18 months for the vaccine to develop And we have not yet seen the full data from the clinical trials, which will then be reviewed or published in a medical journal.
– Pfizer signed a $ 750 million agreement with BioNTech in March to jointly develop a potential vaccine and perform clinical trials in April; Vaccine testing began in the United States in May after testing in Germany a month earlier.
– trials continue globally in 154 locations, including in Germany, Japan, Brazil and various places in the United States with volunteers over 12 years old.
