What you need to know
As Taiwan’s government is stepping up to secure vaccine supplies from global manufacturers, it should boost confidence in domestically-produced vaccines by asking the companies to kick off Phase III trials.
Vaccines remain scarce. Countries like Israel, France, and Germany are already planning to give Covid-19 vaccine boosters to the elderly and vulnerable. However, there are still many others, Taiwan included, where people are eagerly waiting for their first dose.
Given the limited supply of vaccines, it is important to revisit why vaccines are rolled out in the first place — to reduce the risk of serious diseases, hospitalizations, and death. In many countries, those who are clinically extremely vulnerable, including healthcare workers, the elderly, and immunocompromised patients, have yet to receive their first dose. In this supply-constrained environment, a third dose given to one person means someone else is not getting their first dose. As each vaccine purchase and administration is currently a zero-sum game, the global priority should be ensuring people receive their first jabs, not their third.
If third doses are to be administered, the decisions must be guided by solid scientific evidence. For certain groups of people, a third dose may be necessary to elicit a proper immune response. A study showed that solid-organ transplant recipients had a significant increase in antibody prevalence after a third dose (from 40% to 68% after the third dose). 90% of dialysis patients, according to another study, had an immune response after two doses of an mRNA vaccine. But if their antibody titers were still low after two doses, they were highly unlikely to develop a strong response after a third dose.
As of August 10, only 30% of the world’s population has received at least one dose of a Covid-19 vaccine. According to the WHO Director General Tedros Adhanom Ghebreyesus, of the more than 4 billion vaccine doses administered so far, more than 80% have been used in high-income and upper-middle-income countries. As of August 8th, 1% of people in low-income countries have received at least one dose of Covid-19 vaccine versus 56% of people in high-income countries, 38% in upper-middle-income countries, and 20% in lower-middle-income countries.
Rich countries are hoarding vaccines, with the amount enough to cover their populations their secured or optioned supply agreements five to seven times over. The vaccine policy and purchasing activities in one country ultimately impacts what happens in another.
But hoarding vaccines will not help rich countries in the long-run. What would be effective is making sure people in other countries receive vaccines. This reduces the possibility of needing to administer additional jabs in the future. The longer this virus is allowed to infect people and mutate, it raises the risk of an escape variant, against which current vaccines are no longer effective. In that case, new vaccines will be needed to combat it.
While some could argue that rich countries could donate their excess vaccine supply to poorer countries, this is happening only when the rich country’s local population has sufficient access. As of August, the United States has seen about one million doses going to waste due to expiration, storage issues, appointment no-shows, and unused doses from open vials. If a new vaccine is needed in the future, what is to stop this hoarding behavior from happening again? COVAX was designed to provide a more equitable procurement and distribution process for poorer countries, but that alone is not enough.
As the pandemic continues, investments are required to expand manufacturing capacity for vaccines in countries that are already mass-producing them, including in Europe and North American. But this also needs to happen in developing nations to strengthen global health security and address the rising inequity in vaccine access. As effective vaccines are identified for production in these new manufacturing facilities, voluntary licensing and technology transfer agreements will ensure fair pricing models and affordable vaccines for low and middle-income countries.
There is growing consensus among world leaders as they consider a waiver of intellectual property protections for coronavirus vaccines. Pharmaceutical companies can do more by donating additional vaccine doses, selling vaccines at reduced prices to countries in need, and assisting in technology transfer agreements to expand manufacturing capacity.
Taiwan’s approach to vaccine procurement is strategic to prepare for the future. The government has initiated discussions with Moderna in the hopes of manufacturing its mRNA vaccine in Taiwan. Within three years it plans to complete construction of a second vaccine manufacturing facility.
But what can Taiwan do now? The country continues to struggle with vaccine supplies. Despite the availability of a domestically developed vaccine, only 1.4% of those who registered for vaccinations chose the domestic vaccine by Medigen Vaccine Biologics Corp. The Kuomintang, the opposition party, has vowed to appeal the emergency use authorization of MVC’s vaccine because it has not completed Phase III trials. This distrust of the domestic vaccine in part stems from concerns about safety and effectiveness, similar to why people from other countries are unsure or unwilling to get a vaccine.
One way to allay these concerns is to complete a local Phase III trial with a blinded crossover approach. This is a trial where researchers compare the results of two groups that receive different vaccines. As an example, the first group of participants who sign up for the trial would not know they are receiving a Moderna vaccine. The second group of participants would not know they were receiving the domestically produced vaccine. The results would then be compared in terms of correlates of immunity. This scheme can help enroll participants in the trial if they have a 50% chance of getting a proven vaccine.
The drawback of this kind of trial is it requires triple the sample size or length of the trial compared to one involving the use of placebo. However, it may be the norm for Covid-19 vaccine trials since it can be unethical to give people a placebo vaccine during a pandemic when other vaccines are available. If successful, this could bring confidence back to Taiwan’s domestically-produced vaccines.
Editor: Bryan Chou, Nicholas Haggerty (@thenewslensintl)
If you enjoyed this article and want to receive more like it in your news feed, please be sure to like our Facebook page below.