From FDA approvals to the “cold chain,” how far are we in the last mile to recovery?
The vaccine race is far from over.
When the world started spiraling out of control due to the novel coronavirus last year, big pharmaceuticals made it an undertaking to come up with a vaccine that would counter the spread across 219 countries around the world. A number of these vaccines have already crossed the hurdle of clinical trials and approvals, and are being readied for mass rollout.
The What’s What of Vaccine Development
SARS-C0V-2, the virus that causes COVID-19, has spike proteins that surround the membrane of the viral structure. When the virus comes into contact with our body’s cells, these spike proteins hook themselves onto our cells’ receptors. Imagine puzzle pieces interlocking with one another. The goal of these COVID-19 vaccines is to make the body mimic the response it gives with the presence of spike proteins, or to produce the spike proteins themselves.
There are the AstraZeneca and Johnson & Johnson vaccines, which are considered as “viral vector-based” vaccines, a type of vaccine created from a genetically modified form of the virus to trigger an immune response from the body. The vaccine serves as a carrier of readable instructions that instruct how to produce the spike protein in the body. These newly produced spike proteins would then alert our immune system to the presence of foreign bodies, which the system would produce antibodies for.
The Pfizer-BioNTech and Moderna vaccines work in a similar way, although these are mRNA vaccines. Instead of using a virus as the vector, the code — the mRNA — is delivered directly to our cells to instruct them to develop the SARS-CoV-2 spike proteins and generate the corresponding antibodies.
Lastly, Novavax is a protein subunit vaccine. With this type of vaccine, the spike proteins present themselves to the cells to elicit the antibody response. This antibody response can be thought of as a training ground for the immune system in the sense that when the actual virus enters the body, it would immediately recognize that foreign body and would know how to respond.
The development of these vaccines — which consists of three stages — happened in much shorter timelines than usual. While previous vaccine development averaged 10 years, production of those for COVID-19 had been condensed to less than 12 months. On average, it takes successful vaccines over four years to go from Phase II to full regulatory approval. But for the COVID-19 vaccine, it took less than one.
All three stages test for a vaccine’s safety: Phase I is a research-intensive stage wherein antigens — foreign substances that induce an immune reaction in the body — are looked into. This particular stage help determine which antigens would elicit the same reaction to an actual virus or bacteria so that it may be replicated. Phase II, meanwhile, further tests safety, dosing, and even possibly the effectiveness of the vaccine. Lastly, Phase III of the trials determines the efficacy — the ability to produce an intended result — of the vaccine by waiting to see how many people are actually made immune from the disease.
While it may seem that the worst has been overcome, one major problem still persists: figuring out how to get the vaccines to the people.
The Last Mile
According to the World Health Organization (WHO), herd immunity is attainable depending on the percentage of people who need to be immune. This percentage varies per disease and is relatively unknown in terms of COVID-19. WHO supports attaining herd immunity, but only through vaccination — not by having a number of people be erroneously infected by the disease.
Another critical hurdle in vaccine distribution is the amount of doses needed to be made available to the public. In 2019, the world population stood at 7.67 billion. As most of the developed vaccines require two doses for full effect, there is a need for approximately 15 billion doses for everyone worldwide. A three-week or a one-month interval is needed before getting the second shot. Hence, a shortage of supply is a highly likely scenario. However, resorting to only providing one shot per person and practicing unethical methods are unacceptable.
In an interview with Science News, AP Moller-Maersk special projects logistics head, Robin Townley, describes the current situation as not just a race out of the laboratories but a “race to the patient.” True enough, what he dubs as the “last mile” of the vaccine journey deals not only with traversing distances from the laboratories to the logistics partners; it also deals with regulatory grants for authorization of use in each country. In this regard, only Pfizer-BioNtech’s and AstraZeneca’s COVID-19 vaccines have been approved by the Philippine Food and Drug Administration as of January 28. The former is the brand that could have been made available to the country for emergency use had the Department of Health (DOH) been able to secure the negotiations in December of last year.
From the looks of it, the Philippines is greatly behind in terms of securing deals with vaccine manufacturers — more so from significantly reliable brands. Although the Pfizer-BioNTech vaccine has been approved by the FDA, there is no assurance that the ongoing deals with the company will yield positive results. Waiting on other applications to be approved by the FDA will take more time, but it is the only way to go to uphold public health standards.
With cases still on the rise, the dilemma is whether or not we can catch up just in time to curb the situation in the Philippines — especially with the new strain of COVID-19 already detected in the country.
The Cold Chain
Another key logistical challenge to address is the availability of cold storage transportation facilities that would enable the vaccines to be transported without losing their effectiveness. The cold chain must be followed all throughout manufacturing, distribution, storage, and the administration processes. As it stands, it takes a certain science and meticulousness to avoid breaking the cold chain at any point before the vaccines reach a recipient. While the Pfizer-BioNTech vaccine needs to be stored at −70 degrees Celsius to be preserved, all the developed vaccines need to be stored at 2 degrees to −20 degrees Celsius to prevent degradation.
Furthermore, storing vaccines at cooler temperatures lessens the need for using more preservatives and the risk of bacterial growth within the vaccine. As of 2019, the cost of constructing cold storage facilities ranges from USD 150 to USD 170 per square foot. In addition, the approximate land area needed for a cold storage facility is at least an acre — or 43,560 square feet. With that land area needed, construction cost could be as high as USD 7,405,200 or roughly PHP 358 million. Cold chain logistics is not a cheap undertaking, which explains why not all countries may be equipped with the large budget needed for these facilities.
Are We Following Suit?
Among the first to lead the vaccination of their constituents are countries such as China, the European Union states, Israel, Russia, the United Kingdom, and the United States. When the first vaccines were approved for use, nearly 50 million doses were administered — a great number, if realized. With the extent of global demand, third world countries such as ours may have to wait a longer while.
As to what other ASEAN countries are currently up to, Singapore has secured Pfizer-BioNTech vaccines as early as December 21 of last year. Indonesia leads next, already having given over 9 million doses of the vaccine to frontline workers in the past 30 days. Other ASEAN countries are either expecting deliveries of their requested vaccines in the middle of 2021, or are coordinating with pharmaceutical companies to procure their own. Brunei is expecting to have vaccines in the first quarter of 2021 that will be enough to cover 50 percent of their population.
Meanwhile, Cambodia is expected to import vaccines from both China and Russia. Cambodia is one of the countries offered financial assistance by the Australian government for vaccine coverage, along with Indonesia and Myanmar. The latter currently seeks assistance from the Gavi and Covax programs to acquire vaccines.
Concurrently, Laos is also in negotiations with China to acquire more supplies for their trials with Russia for the Sputnik V vaccine. Malaysia, on the other hand, has signed a deal with Pfizer for 12.8 billion doses that will be provided for free to Malaysian nationals when their vaccination program commences in the first quarter of this year. Singapore, on the other hand, is working on producing their own vaccine, which is expected to be available by the first quarter of the year, and targets to have all adults vaccinated by September. Vietnam, like Singapore, is also trying to procure its own vaccines but has already signed an agreement with a Taiwan-based company to secure around 3 to 10 million vaccine doses. Thailand, meanwhile, is already expecting delivery of vaccines in mid-2021 and is in the middle of discussions to secure more vaccines.
The Philippines, as of writing, aims to commence its vaccination programs by June 2021. Lately, the national government is facing backlash for choosing Sinovac — which has been reported to have a 50.4 percent efficacy versus the above 90 percent efficacy of other approved vaccines — as the nation’s primary supplier. To put things in perspective, these rates still do not include logistical requirements, personal protective equipment needed, and storage requirements.
A press release last January 18, however, clarified that the previously published prices “were indicative market prices based on the rates published by different manufacturers generated for the purpose of estimating the proposed budget for the vaccination program,” and were not what the government and the manufacturer had agreed on.
Furthermore, a Pulse Asia survey dictates that less than a third of the Filipino population — only 32 percent of the 2,400 respondents — are open to getting vaccinated against COVID-19. The survey, which was conducted from November 23 to December 2 of last year, also revealed that 47 percent of the respondents are against vaccination due to safety concerns. The remaining 21 percent, meanwhile, are undecided.
A Longer Stretch
Considering that this is a race against time, our national government’s overall preparedness and sense of urgency should be improved. This can be done by acknowledging our shortcomings and by learning from what neighboring countries have done right.
For one, there needs to be a proactiveness from the government in securing negotiations with various pharmaceutical companies. Prioritization of particular brands with the welfare of the Filipinos in mind — not of personal gains — must be exercised, or else all efforts would be put to waste.
Furthermore, as the DOH is also in charge of approving the vaccination program proposals of the LGUs, they must be able to recommend and adopt the practices of successful countries that have already administered vaccines. Another course of action is to secure at least regional availability of cold storage facilities, especially for vaccines whose prescribed storage temperatures are lower than the capabilities of regular freezers. As storage temperature is one of the main concerns about the vaccines, this would be a crucial step in maintaining their effectiveness.
As the entire country waits with bated breath in anticipation of anything close to a cure, it’s high time for the people in power to acknowledge their shortcomings, learn from what neighboring countries have done right, and pivot toward what needs to be changed.
More than ever, it’s time we move fast before it’s too late.
This article was written by our contributor, Dab Castaneda.