The results of the trials of the COVID-19 vaccine are beginning to come in and they look fantastic. As early as December, we might see delivery. This is the news we’ve been waiting to hear, with the first findings from their phase 3 vaccine trial announced by Pfizer and BioNTech. A sigh of relief, 94.5 percent effectiveness for your vaccine, another historic day.
The fastest vaccine ever to be produced in the history of medicine took four years. This took 8 months. As we head into 2021, these vaccines have the potential to be real game changers. The U.S. epidemic can be ended successfully and Pfizer is not the only one making big strides in the vaccine race.
We have three highly successful candidates for the vaccine now and at least one more on the way, but there is one major problem: getting the vaccine physically to all of the more than 330 million people living in the U.S.
The worst thing that may happen is that we have the vaccine shipped and we are not ready for the vaccine to be administered yet. The introduction of the delivery and program would be the most difficult vaccine program ever sought to achieve herd immunity in human history.
Around 70 percent of the population needs to be vaccinated or have natural antibodies, experts say. Two doses are required for Pfizer’s vaccine. That’s 462 million herd immunity doses and 660 million herd immunity doses that will need to be produced, funded, distributed and administered for the whole population, and even then, Pfizer doesn’t know how long protection against the virus will last. So how are we going to get every person living in the U.S. a Coronavirus vaccine? For those in remote corners of the world in particular? And how much is this going to cost?
It takes a whole lot of steps to administer a vaccine to the general population, much of which must happen simultaneously. You have public relations efforts, equipment purchasing, personnel recruitment, vaccine provider training, inventory monitoring and ordering technology creation and deployment, not to mention the additional difficulty in this pandemic in ensuring that ALL vaccine sites are secure and will not contribute to the spread.
Our routine immunization system is usually run in the U.S. by two channels, the public sector and the private sector, although the COVID vaccine will follow a different model. This is a nationalized initiative. There’s no private sector, no access to markets. You can’t go out and buy this vaccine in the free market if you have a hundred bucks. It is paid for by the federal government. The federal government is responsible for the delivery of the vaccine to immunization services who have registered to participate in this national vaccination program, partnering with state and local public health to get the vaccine.
The CDC offers a national playbook to be adopted by states, but industry experts claim that a lot of the delivery burden would likely fall on individual states and local governments. These states are going to tailor the response to fit their people’s needs, their unique circumstances.
To keep pace with delivery, most states will also need to beef up their IT networks. One of the most difficult components of this whole rollout is just keeping up with who has had what vaccine, how many doses, and most importantly, what the new inventory level numbers are.
Another big concern making sure all these different systems speak to one another. Some of those systems have not been used before so I believe that we all have fair concerns that some stumbling blocks will occur.
Operation Warp Speed, an initiative to produce, manufacture and distribute a Coronavirus vaccine, has been launched by the Trump administration. Four COVID-19 vaccines and large-scale phase 3 clinical trials are in progress as of November 2020.
That’s the stage where a large number of individuals are tested by researchers to equate an experimental therapy with conventional treatments and then determine the overall risks. We have the vaccine developed by pharmaceutical giant Pfizer with its German partner BioNTech, another from the U.S. biotech firm Moderna, the British pharmaceutical corporation AstraZeneca, in partnership with the University of Oxford, is working on another and then Johnson & Johnson is working on a single dose injection. Of those four, all but Pfizer were seeded with money for R&D by Operation Warp Speed.
Pfizer didn’t, take a single cent from anyone. The explanation is because they wanted to free their scientists from the bureaucracy that comes when a governmental agency presents cash. And to keep Pfizer out of politics as well. It is worth remembering that Pfizer will be receiving almost 2 billion from the U.S. government to manufacture and distribute 100 million doses of its vaccine.
The vaccine from Pfizer also happens to be the first one in the public consumption pipeline. So let’s start with a look at the factory-to-arm supply chain.
The CDC is next on deck when the FDA grants emergency permission, they determine who gets the vaccine and when and the department has already established a priority model for rationing those initial doses. Meanwhile, when the vaccine was already in the thick of clinical trials, at two of the company’s manufacturing sites in Michigan and Belgium, Pfizer was making hundreds of thousands of doses.
Pfizer’s is extremely hard to store and package, unlike the three other vaccine candidates. It is best to keep it super cold. We’re talking minus 94 degrees fahrenheit, cold with dry ice in a sealed case. There are anywhere from 1,000 to 5,000 doses in that suitcase sized box, what they call a thermal shipper. For clinics that don’t have the requisite specialty equipment, these custom thermal shippers serve as mobile freezers. The countdown clock starts once that box of doses arrives at its destination.
In those boxes, vaccines will last for up to 15 days. As long as the thermal shipper is not open more than twice a day each time for no more than a minute. It is also important to replenish the dry ice within 24 hours of reaching its destination, then again five days later and another five days afterwards. At that point, in a regular refrigerator where it lasts for about five days, the vaccine must be thawed out. So there’s actually just 20 days between delivery and injection without super low temperature freezers. That, because of all these highly complex protocols, doesn’t leave much of a margin for error.
Pfizer also opted out of the government’s decision to use a third party distributor, Mckesson. They’re doing it themselves, instead. The CDC will accept state vaccine orders and authorize those based on the number of doses assigned to that specific state by the CDC. The CDC will then announce that Pfizer will then supply the vaccine to the location specified by the state and the sum specified by the state to Pfizer. And the state will then prescribe the vaccine from there as it sees fit. And bear in mind that it is administered in two doses and given a few weeks apart, so it is highly critical that states play a role in managing delivery.
64 states, cities and territories have issued their draft preliminary delivery plan, and more are expected to arrive shortly. We see some states really planning to store it themselves to administer the delivery and drive it out to these remote areas, and we see some states coming up with more organized places to get the vaccine in order to actually prepare those clinics ahead of time and not to send the vaccine until the day that those clinics will take place.
The fragility of this vaccine makes distribution much more of a problem in rural areas where populations are more dispersed, but Pfizer is not worried. It’s filling as many as two dozen trucks a day and sending them directly to local Airports. This amounts to the regular transit of approximately 7.6 million doses to countries around the world, and on November 17th, in Rhode Island, Texas, New Mexico and Tennessee, the company initiated a pilot delivery program for the vaccine to try to solve these ultra-cold storage distribution problems.
Johnson & Johnson is a one-dose injection, and the Moderna vaccine stayed stable for up to 30 days at 36 to 46 degrees fahrenheit, the temperature of a normal home refrigerator, with the other vaccines proving to be much easier to deal with. Plus, at minus four degrees fahrenheit it lasts for six months, these are fairly normal conditions in the pharmaceutical industry.
Another major pro, order size, Moderna provides batch sizes of 100 doses as opposed to the minimum order of 975 doses from Pfizer. In addition, unlike Pfizer, Moderna would use Mckesson, a third-party distributor. They will be responsible for providing both the vaccine and all ancillary equipment, such as syringes and pads for preparing alcohol.
A collaboration with large pharmacy chains and independent pharmacies has been established by the federal government. Joshua Michaud is an associate director at the Kaiser Family Foundation for global health policy. He says that the U.S. Around 60 percent of pharmacies nationally are regulated by government agreements. They will ship vaccine doses directly to those pharmacies, and the vaccines will be administered to individuals by those pharmacies. What the CDC thinks it would take to administer the vaccine is anywhere between five and a half and six million dollars. And the CDC right now doesn’t have that income. The government has invested about $10 billion to create the vaccine, but just $200 million has been allocated by the CDC to states so far. We need the federal government to be a competent collaborator for every state. In mid-December, $140 million more is expected to arrive, but that’s only a fraction of what health departments think is required.
Right now the state and local governments are under financial pressure and stress, both a decrease of tax revenue and a rise in costs due to the pandemic.
Of the $8.4 billion sought by health departments, nearly 40 percent is projected to go to recruiting and training. The remainder is for facilities, IT, modernization, reporting, management of the cold supply chain, supervision and outreach. What we did was look at how much things cost in 2009 as part of the planning and what sorts of stuff went into the H1N1 effort. This needs manpower. For example, you can possibly vaccinate 30 people an hour with one nurse with the Pfizer vaccine in a flu clinic. Pfizer calculates 10 minutes per session. Scale it up and in an hour, you’re looking at vaccinating six people.
It’s not going to be easy to mobilize that kind of cash quickly, particularly because talks on the capitol hill remain in limbo about extra stimulus money. States are unable to do so on their own.
In October, 64 states, major territories and cities were requested by the CDC to apply their plans to administer the vaccine. For instance, Virginia included a gap analysis and found that to get ready it required around 121 million dollars.
The state has so far collected just under $5.4 million. The cost benefit analysis is fairly straightforward here. In order to ensure that we do a good job of delivering this vaccine to the places it needs to go, we need to take whatever measures necessary and have whatever resources are needed, because this is such a vital part of our resuming normal economic operation.
It would be another key to life returning to normal to resolve the weariness of the American people to get the vaccine, and polls indicate a disturbing pattern. A May survey by the Washington Post and ABC found that 7 out of 10 Americans were optimistic about the vaccine, but by July that number had fallen to 66%, by August to 61%, and by late September only 50% of Americans said that if it was available today, they would get the vaccine. According to a gallup panel, the types of things we need to do to win the public’s trust in this initiative include being transparent and frank about what we know and what we don’t know. As we know, the number one factor in a person’s decision to get vaccinated is a good recommendation from a health care provider.
We are also responsible for ensuring that these health care providers know what they need to know in order to feel comfortable answering questions from their patients. It is unusual to have a vaccine developed in eight months, so roadblocks are expected.
But the question remains: when will the average citizen really be able to get the COVID-19 vaccine? As of now the intention is to quote “prioritize” for those initial doses. Prioritization would be focused on risk, and priority would be given to critical staff and at-risk individuals.
It is likely that the federal government will have added 20 to 30 billion dollars to its pandemic relief by the time the general public is vaccinated, a mountain of taxpayer money only for the vaccine alone.
Yet experts believe it would be worth the investment in all cases. We’ve got trillions of dollars missing. We will never get jobs, livelihoods and most importantly, human lives back, and no amount of investment will get those lives back now.
But the biggest investment we can make will be spending a few billion dollars in maintaining a strong public health system and bringing the public a vaccine to put this pandemic to a close. Don’t forget to wear a mask.
Source : Youtube