Ministry of Health - World Health  Organization (WHO)

Eighth Constitutional Government

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Dili, Timor-Leste, 24 June 2021

Joint Press Release

On safety and efficacy of Oxford-AstraZeneca COVID-19 vaccine considering the stand of Australia Technical Advisory Group on Immunization (ATAGI)

COVID-19 vaccination remains one of our most effective measures in response to the current COVID-19 outbreak, significantly reducing a person’s risk of being infected, seriously ill, hospitalized or dying from COVID-19. As new information and evidence become available, we are also continuously assessing our efforts and response. Our communities’ continued safety and protection are at the forefront of all aspects of our efforts.

There are EIGHT COVID-19 vaccines, which have received WHO’s emergency use licence (EUL). There are strict protections in place to help ensure the safety of all COVID-19 vaccines. Before receiving validation from WHO and national regulatory agencies, COVID-19 vaccines must undergo rigorous testing in clinical trials to prove that they meet internationally agreed benchmarks for safety and efficacy.

Almost 200,000 COVID-19 vaccine doses have been administered in Timor-Leste and we have no recorded case of serious side effects so far. This is an incredible achievement for a country that relies mainly on the AZ vaccine and is further proof of the safety of this vaccine in our population.

Regarding the safety of the vaccines used in Timor-Leste, the MoH and WHO Timor-Leste would like to reiterate some salient points:

• The WHO interim recommendation updated and issued on 21 April 2021  categorically states that the Oxford AstraZeneca )AZ) vaccine produced by different manufacturers pre-qualified for emergency use rely on the core clinical data for regulatory evaluation. Consequently, these vaccines are considered safe and effective for general use.
• The WHO recommendations advocate for continued use of the AZ vaccine for ages above 18.
• In revised Australian recommendations, AZ vaccine will continue to be administered to persons over 60 years of age.
• In Australia, those under 60 years of age, who have had first dose AZ prior to the June recommendations, are still getting AZ vaccine as a second dose (as per recommendations from Australian regulators).
• Based on revised Australian recommendations, AstraZeneca vaccine still can be used in adults aged under 60, in situations where alternate vaccines are not available.
• After considering existing Covid-19 disease transmission status and risk harm analysis, other countries have also included age restrictions in place limiting use of AZ vaccine among lower age range. e.g., in the UK, the age cut-off is 40.
• In countries with ongoing high COVID-19 virus transmission, like Timor-Leste, benefits of vaccination (preventing people getting severe Covid-19 disease, hospitalization and death) far outweigh the rare risk of getting Thrombotic Thrombocytopenic Syndrome (TTS) and hospitalization and death due to TTS.

Australia’s decision does not change Timor-Leste approach for vaccination given the current community transmission and possible introduction of COVID-19 variants. All unvaccinated individuals in Timor-Leste are at risk from getting the Covid-19 disease, hospitalization and death.

It is important to note that serious adverse events following immunizing following AstraZeneca vaccine remain very rare. To date, no confirmed cases of serious adverse events following immunization including TTS have been reported in Timor-Leste despite almost 200,000 AZ vaccine doses being administered.

This is a phenomenal achievement not only of our community coming together to protect each other, but also the tireless efforts of our vaccination teams in ensuring vaccines are being delivered to communities across the county in a safe manner. Furthermore, Timorese doctors are well trained and have the resources on hand to treat individuals if such rare incidents do occur.

After a thorough consultation with experts within and outside WHO, it has been satisfactorily concluded that the benefits of AZ vaccine far outweigh the risk. Therefore, we confidently advocate the continuation of the COVID-19 vaccination using the AZ vaccine. ENDS