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‘Safe and effective’: WHO authorises emergency use of China’s Sinopharm vaccine

The World Health Organisation (WHO) has given its stamp of approval  to China’s Sinopharm vaccine, the first jab developed by a non-Western country to obtain emergency authorisation.

Initially Sinopharm’s developer had released very little data publicly leading to uncertainty about the shot’s efficacy but WHO said it had validated the “safety, efficacy and quality”.

The vaccine is one of two main Chinese shots that collectively have already been given to hundreds of millions of people in China and countries in Latin America, Africa and Asia.

Already the WHO has approved Pfizer, AstraZeneca, Johnson & Johnson and Moderna and there have been reports of side effects connected to these variations.

In the latest, Europe’s medicines regulator is reviewing reports of a rare nerve-degenerating disorder (Guillain-Barré Syndrome) in people who have received AstraZeneca’s COVID-19 vaccine.

The EMA is also looking into reports of heart inflammation with Pfizer-BioNTech’s vaccine, called Comirnaty, and Moderna’s shot, it said.

The EMA and other regulators are already reviewing the possibility of rare blood clotting conditions with COVID-19 vaccines, including AstraZeneca’s.

WHO’s endorsement of China’s vaccine is the first time it has given emergency use approval to a Chinese vaccine for any infectious disease.

The official tick offers a guideline to health regulators around the world that the drug is safe and effective and opens the door to it being shipped to poorer countries in the COVAX initiative.

The Sinopharm jab is administered in two doses to those 18 and older.

It is one of two Chinese coronavirus vaccines — this one developed by its Beijing Institute of Biological Products and the other by the Wuhan Institute of Biological Products.

Beijing Biological Products Institute has not released detailed data but has said the jab is 79.34 per cent effective in preventing people from developing the disease.

A separate group advising the UN agency on vaccines said it was “very confident” the Sinopharm vaccine protected people ages 18-59.

But the group said it had a “low level of confidence” of the vaccine’s efficacy in people 60 and over and there were concerns of serious side effects in that age group.

Reports of nerve disorder after AstraZeneca jab

Europe’s medicines regulator says it is reviewing reports of a rare nerve-degenerating disorder in people who have received AstraZeneca’s COVID-19 vaccine, and has requested more detailed data on the cases from the company.

As part of a regular review of safety reports for the vaccine, Vaxzevria, the European Medicines Agency’s safety committee is analysing data provided on cases of Guillain-Barre syndrome, the regulator said.

The EMA is also looking into reports of heart inflammation with Pfizer-BioNTech’s vaccine, called Comirnaty, and Moderna’s shot, it said.

Both the vaccines use new mRNA technology to build immunity against the coronavirus.

Guillain-Barré Syndrome is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibres.

Most cases follow a bacterial or viral infection, and develop over the course of days or weeks.

It is an extremely rare, known risk associated with respiratory and gut infections, as well as some vaccinations in the past.

AstraZeneca is already under the spotlight because of potential blood-clotting side effects in people aged under 50.

-with AAP

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