By Silvia Babo, Graziela Trindade da Cruz no Joao da Cruz Cardoso
After the affirmation of community transmission of Covid-19 in Dili by the Integrated Center for Crisis Management of Timor-Leste on 25 April 2021, the National Parliament approved the request of the President of the country to extend the State of Emergency for another 30 days on 28 April 2021. As of 10 May 2021, the country has 3,353 Covid-19 confirmed cases of which 2,811 are in Dili. Following the approval of a National Vaccination Plan against Covid-19 on 15 February 2021, the Government of Timor-Leste opted for AstraZeneca vaccine as the safest and most appropriate for the country in accordance with the recommendation from the World Health Organization (WHO).
Timor-Leste received first dose of Covid-19 vaccine on 5 April 2021 through the COVAX Facility. After the arrival of the first 24,000 doses of AstraZeneca vaccines, the vaccination campaign commenced on 7 April 2021 targeting the health workers, frontline workers, and all those eligible to receive the vaccines in the first round of distribution. To date, the first doses of vaccines have been completely administered. However, an unverified side effect of vaccine has been reported in the local news media in addition to certain statements from political party, and spread of information through the social media about the negative effects of the vaccines, which cast doubt among the population. Given this situation, are Covid-19 vaccines safe?
Nowadays, vaccine is vital for prevention and control of infectious-disease outbreaks that are fatal to human lives. WHO explains that vaccines work with body’s natural defenses to build protection, which makes a person immune or resistant against an infectious disease. Vaccines do not only protect an individual but also help protecting an entire population of a country because when enough people are immunized, the opportunity for the disease outbreak becomes very low since the virus cannot easily spread from one person to another, a phenomenon referred to as herd immunity or community immunity. The herd immunity is crucial because it can protect populations that cannot be vaccinated such as infants or young children and those who have certain medical conditions. An example of herd immunity occurred in Gambia where coverage of less than 70% Haemophilus influenzae type b (Hib) vaccine was adequate to eliminate Hib disease in the 1990s. Given the vulnerability of the country, Timor-Leste must work hard to ensure that enough proportion of the population receives vaccines to build herd immunity, which will be vital in the fight to eliminate the disease.
In a pandemic situation where vaccines are developed quickly, questions about safety are expected. However, in the medical field, every vaccine must go through extensive and rigorous testing and scientific evaluation from regulatory authorities to determine that vaccines are safe. Similarly, Covid-19 vaccines have to follow standard vaccine development process before they are authorized for use in any country. In the European Union, vaccines such as AstraZeneca have to be evaluated by the European Medicine Agency (EMA) before they are authorized. Given the urgent needs for vaccines due to Covid-19 pandemic, manufacturing companies may use various approaches to reduce development timeline by mobilizing more human resources or combining clinical trial phases, but regulatory requirements to ensure standards of quality, safety and efficacy must not be compromised. Similarly, all the vaccines for Covid-19 are required to go through WHO emergency use listing (EUL), a process where quality, safety and efficacy are assessed before being approved for deployment. Therefore, if proven that people in Timor-Leste get sick or pass away due to AstraZeneca vaccine, it does not only raise questions about health care workers in Timor-Leste or the manufacturing companies, but it also raises concern about the credibility of regulatory authorities such as EMA and/or WHO EUL process. This may trigger public distrust on overall process for development and approval of vaccines, and medical community.
Since AstraZeneca vaccine has been listed for emergency use by WHO based on the consideration of the Strategic Advisory Group of Experts (SAGE) and review of EMA, it is considered safe. For developing countries like Timor-Leste, AstraZeneca vaccine is the most appropriate because it is cheaper and can be stored in a regular temperature (2⁰ to 8⁰ C) compared to other vaccines even though AstraZeneca has lower efficacy. Regular temperature requirement means that the country does not have to spend heavily on the storage facility, and the vaccine can be easily transported at a reasonable cost. However, the obstacles for these vaccines to reach developing countries like Timor-Leste are not simply related to the availability of the vaccines, but also the timing and distribution of the vaccines that are inextricably linked with the nature of the relations between the developed and developing countries.
Looking from political economy aspect, the Covid-19 pandemic also exposes inequality between the rich and poor countries, particularly in production and distribution of the vaccines. Many experts have iterated that equitable access to vaccines will contribute to prevention of cases and deaths due to the Covid-19 virus. Despite the call for the right of production of the vaccines in developing countries, the wealthy countries oppose due to concerns such as rights of patent, declining public confidence in vaccine safety, and less involvement of organizations and commercial companies in the vaccine field due to lack of investment return. On the contrary, rich countries argue that there has never been an intention to exclude other countries but they simply need to respond to massive death tolls in their own country first before helping others. Regardless of the arguments, the Covid-19 pandemic affects global economy, and according to the International Chamber of Commerce, the economic cost for the rich countries can reach US$5 trillion if vaccines are not equitably distributed to developing economies. To address the concern related to the distribution of Covid-19 vaccines, COVAX facility was launched to accelerate the development, production, and equitable access to Covid-19 tests, treatments, and vaccines via global cooperation. It is the COVAX Facility arrangement that enables Timor-Leste to acquire 24,000 doses of AstraZeneca vaccine covering 20% of its population, which otherwise would have been almost impossible to acquire in early 2021.
Concerns about the link between blood clot incidents and AstraZeneca vaccines are not only raised in Timor-Leste but shared globally. However, studies have found that the rate of blood clot incidents is 8 to 10 times higher among people diagnosed with Covid-19 compared to those who have received vaccines (39 per 1 million among Covid-19 patients and 4 in 1 million among vaccine recipients). Similarly, Australia’s medical experts have reviewed the data on the incidence of rare blood clots after Covid-19 vaccination and found that the rate of blood clot incidence occurring among people who have received AstraZeneca vaccine is lower than the incidence of blood clot occurring naturally. Moreover, EMA and WHO have stated that there is no indication and evidence of conclusive causal link between the blood clot incidents and AstraZeneca vaccine. Therefore, vaccines such as AstraZeneca are still vital for the global fight against the Covid-19 pandemic.
For Timor-Leste, the obstacles are not only about ensuring the availability of vaccines and addressing their safety concerns, but also misinformation about vaccines from unreliable sources that feeds the public. In this regard, the government of Timor-Leste must ensure that correct information is provided to the general public constantly through all the available means, including the social media. For instance, contrary to the common perception, getting vaccinated does not mean that a person will never get infected by the virus again, but it simply means that the person’s immune system has been improved to resist the virus, which allow the person to avoid hospitalization, severe case, and death due to Covid-19 disease. That is why people still need to follow prevention measures such as wearing masks and washing hands even after getting vaccinated. Given the grave consequences of the Covid-19 virus, the government, health workers, and other frontline workers have to be given opportunity and support to carry out the measures for fighting against the virus. Most importantly, the leaders of the country have to put their differences aside and work together to overcome the menace of Covid-19.