Risk Assessment Report – 11 November 2020

• Worldwide, there have been over 51.73 million cases and more than 1.27 million deaths attributed to COVID-19.

• Brazil’s National Health Surveillance Agency reported a serious adverse event on October 29 in a study participant involved

in a phase 3 trial of the China-based Sinovac Biotech vaccine candidate, leading to a decision to suspend the trial in the

country. Pauses in clinical trials are common and were also seen previously in the phase 3 trials for AstraZeneca and Johnson

& Johnson’s vaccine candidates. The pause was aimed to further evaluate the data and assess reasons resulting in the

incident. However, officials did not elaborate on the details of the serious adverse event, due to privacy concerns, or whether

the affected individual had received the vaccine or was in the control group. According to Sinovac, the company will

continue to communicate with its Brazilian partner, while the clinical research will continue to be carried out in strict

accordance with GCP (Good Clinical Practice) requirements.

• Pfizer and BioNTech announced that preliminary phase 3 trial results indicate a 90% effectiveness on its vaccine candidate in

preventing COVID-19 disease manifestation from the presence of SARS-CoV-2 among study subjects without prior evidence

of infection. The first interim efficacy analysis evaluated 94 confirmed cases of COVID-19 in trial participants recorded so far.

The total enrollment of the study is currently at approximately 44,000 people in the six countries including the U.S. Pfizer did not

provide further details about those infections and cautioned that the initial protection rate might change by the time the

study ends. According to Pfizer, the preliminary results are putting the company on track to apply later this month for

Emergency Use Authorization from the United States Food and Drug Administration.

• Singapore targets to have the COVID-19 vaccine by early next year. The first shipments of the vaccine co-developed by

Singapore researchers are expected in the first quarter. Arcturus Therapeutics, the American pharmaceutical company

working with Duke-NUS scientists on the vaccine said this on Monday (November 9) that the vaccine has positive preliminary

results from the early stage clinical trials ongoing in Singapore.

• According to Singapore’s Health Minister on Tuesday (November 10), any company or individual who needs a COVID-19

polymerase chain reaction (PCR) test can procure the service from approved providers starting December 1. Individuals

seeking a PCR test will include people requiring pre-departure testing before travel, will no longer be required to seek approval

from the Ministry of Health for this test. The tests, however, will not be subsidized and those who take such tests at approved

private providers will have to pay for the tests. The move, which kicks in from November 30, will allow Singapore to support a

larger range of needs as Singapore resumes more economic community activities. According to the MOH, enhancing the

accessibility of PCR tests is a critical part of Singapore's strategy against Covid-19 as it moves towards phase three, which will

see larger gatherings of eight people, and potential increases in capacity limits in venues such as museums and places of

worship, as well as for wedding receptions