Dear Editor,
Global policy makers failed to heed warnings that the threat of a pandemic is always present resulting in our current dilemma; the re-emergence of a Coronavirus was predicted after two prior Coronavirus outbreaks (SARS -2003, MERS – 2012) and, given the notorious mutation rate of the influenza virus, an influenza pandemic is always a possibility. COVID-19 has shown the world how ill prepared it was for a pandemic, bringing the developing countries its own challenges because of a lack of vaccine manufacturing facilities in most countries and the surfacing of vaccine nationalism resulting in the lack of equitable distribution of the world’s current vaccine supply. The lesson is that we must be prepared and a key way to do so is to make sure we have adequate and sustainable vaccine supplies against a virus that will likely become endemic (discussed in a letter here on April 26th).
India and South Africa proposed to the World Trade Organization (WTO), in October 2020, a waiver from implementation, application and enforcement of Intellectual Property (IP) rules for COVID-19 related to drugs, vaccines, diagnostics and medical supplies until there is widespread global vaccination and immunisation. There was little support for this from the developed world until the US gave its support for IP waivers on vaccines (only) in May 2021. Prior to this the EU and others said they were open to discussion but argued that this waiver would not change anything in terms of vaccine supplies as many developing countries lacked their own vaccine manufacturing capabilities.
The US supporting an IP waiver on vaccines, if/when in effect, is just the beginning of a long journey to vaccine equity. It’s not going to fix the immediate vaccine supply problem as the details are still being iron out and needs consensus agreement among WTO members (may take months, years or may not even happen). In fact, despite Washington’s backing, negotiations on this matter at the WTO on May 31st failed to change anything as it ended with the EU set to introduce an alternative plan in early June for boosting vaccine supplies and the WHO presently calling on rich countries to share what they bought. Even if vaccine recipes become available most countries in the developing world do not have the manufacturing capabilities and it will take time to acquire technical expertise particularly for working with new technology like mRNA and upgrade existing facilities; don’t forget trade secrets not included in patents. Further, most LAC countries get vaccines through the PAHO and UN led procurement where vaccine quality, safety and efficacy are qualified by the WHO; for this pandemic the COVAX initiative was set up to aid the developing world; however its supply ultimately depends on the same manufacturers that rich countries signed advance purchased agreements with for most of the world’s current supplies (discussed in a letter here on Jan 20th).
The government of Canada announced on April 23 (2021) that it has secured COVID-19 vaccines from Pfizer for 2022 and 2023 with options to extend into 2024. This supports the near consensus from experts that COVID-19 is likely to become endemic and that there is/will be need for a continuous vaccine supply along with modified vaccines (boosters) that maintains efficacy against existing and emerging variants. Therefore, the Latin America and Caribbean (LAC) region should put forward a collaborative effort to ensure sustainable vaccine supplies that can meet regional needs. It’s either this or mostly rely on mechanisms that ultimately depend on advanced countries and we’ve all seen the challenges associated with this during this current pandemic and previous epidemics. I think specific technology transfer agreements is the more viable option.
The best model for a successful technology transfer agreement during this pandemic is that of Oxford University and AstraZeneca. Oxford retained the IP for their vaccine but partnered with AstraZeneca to manufacture and distribute at cost making it affordable to low- and middle-income countries. Technology transfer agreements were set up with manufacturers in 15 countries at 25 cites around the world including the Serum Institute of India, the main vaccine supplier of COVAX, set to deliver 200 million doses with the option for up to 900 million doses.
In the LAC region, Brazil and Cuba have the potential to meet regional demands as they currently produce 54% and 73% of their own vaccine needs respectively (except for COVID-19); next are Mexico and Colombia with 25% and 7% respectively. Four of the thirteen vaccines that Brazil produce (oral polio, MMR, rotavirus and pnemococcal) are through technology transfer agreements and partnerships with European Pharmaceutical companies where only the final stages of production are carried out in Brazil. Through tech transfers they are set to produce the Oxford AstraZeneca vaccine soon while Mexico and Argentina will produce it in a joint venture – the main ingredient will be manufactured in Argentina then sent to Mexico for later production steps and distribution. In addition, União Quimica a private company in Brazil has already produced their first batch of SputnikV. The second largest vaccine portfolio in the region belongs to Cuba with eight of its own and five COVID-19 vaccine candidates (two in phase 3 clinical trials). A good example of a South-South collaboration in the region is between the Institute of Technology in Immunobiology (Bio-Manguinhos) in Brazil and the Finlay Institute in Cuba for the production of the meningococcal polysaccharide A-C vaccine, a WHO qualified product. They produced enough for themselves and countries in the African meningitis belt. Production of the vaccine was done in Cuba while lyophilizing (freeze drying), filling and final steps were done in Brazil (Sáenz et al., MEDICC Rev 2010 12:32-5).
The vaccine industry is a billion dollar one where the production of a vaccine involves many steps including research and development, manufacturing, marketing, sales and distribution; all of it encased within a regulatory framework to ensure product safety, efficacy and quality. Not all steps may be possible in a single country but with collaborative efforts and specific technology transfer agreements, sustainable vaccines supplies are achievable in the region.
Sincerely,
Jacquelyn Jhingree, PhD.
