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Summary
- China-based biopharmaceutical player, Sinovac Biotech’s clinical trials were put on a halt by the Brazilian health regulator, Anvisa, after the detection of a serious adverse event.
- China has already commenced administering its vaccines, including CoronaVac, and thus a safety issue noticed at this stage is alarming.
- Sao Paulo’s Butantan Institute, which is conducting the clinical trials of Sinovac in Brazil, was surprised by the health regulator’s decision.
Anvisa, the Brazilian health regulator, has paused the Chinese pharmaceutical company Sinovac Biotech Ltd’s (NASDAQ:SVA) COVID-19 final-stage clinical trial. The trials were put on a halt due to the detection of a severe adverse event. Sinovac’s COVID-19 vaccine candidate CoronaVac is under late-stage clinical trials against COVID-19.
Such halts, however, are not surprising in large-scale clinical trials. Two vaccine developers AstraZeneca Plc (LON:AZN) and Johnson & Johnson (NYSE:JNJ) had paused their COVID-19 vaccine candidate trials in recent months because of specific serious adverse reactions and recommenced their respective studies after investigation.
Let us dig deeper and discuss in detail-
Sinovac’s COVID-19 vaccine trials put on halt
China-based Sinovac Biotech Ltd is involved in the R&D, manufacturing as well as commercialization of vaccines to protect against human infectious diseases. Currently, the Company is engaged in the development of a COVID-19 vaccine, CoronaVac, which is now in Phase 3 clinical trials.
Brazil’s health regulator Anvisa stated that it could not give further details on what happened because of privacy policies. However, Anvisa mentioned that such incidents included death, serious disability, hospitalization, potentially fatal side effects, birth defects as well as some other clinically significant events.
The setback for China's CoronaVac came on a day when US-based pharmaceutical behemoth Pfizer Inc (NYSE:PFE) and German biotechnology company BioNTech SE (NASDAQ:BNTX) disclosed that their vaccine candidate had demonstrated 90% effectiveness. The positive news sent the share markets soaring, bringing hopes amid a pall of gloom.
Sao Paulo’s state-run Butantan Institute would primarily manufacture CoronaVac. The institute stated that it was surprised by the decision of Anvisa and would hold a news conference on 10 November 2020.
CoronaVac is currently under clinical trials in seven states across Brazil and the federal district where the capital Brasilia lies.
China already commenced administering its vaccines
In China, the administration of CoronaVac and other vaccines has already started. Vaccines are being given to hundreds of thousands of individuals under an emergency use approval. The detection of a serious adverse event at this stage of clinical studies is all the more alarming as there is a possibility of safety concerns.
Vaccine manufacturers from China have been at the forefront of this global race to combat the COVID-19 pandemic by developing effective immunization against the SARS-CoV-2.
Bottomline
With the world desperately waiting for an effective COVID-19 vaccine, healthcare companies have been fast-tracking their respective clinical trials with the help of the governments. The detection of serious adverse events during the late-stage clinical trials is a significant concern amid the increasing spread of coronavirus. However, some experts say that such pauses are not uncommon during large clinical studies. This indicates that despite such a setback, things might get back to normal for Sinovac.
