Bangladesh is set to give emergency use approval to a Chinese COVID-19 vaccine that will pave the way for import of the shots produced by state-owned China National Pharmaceutical Group or Sinopharm, reports bdnews24.com.
The World Health Organization also expects to decide whether to give emergency approval for Sinopharm’s COVID-19 vaccine by next week.
China has already deployed millions of doses of the vaccine, created by the Beijing Institute of Biological Products and called BBIBP-CorV, at home and has exported them to many countries, particularly in Latin America, Asia and Africa.
An emergency listing from the WHO is an indication to national regulators of a shot's safety and efficacy, and would allow the Chinese vaccines to be included in COVAX, the global programme to provide vaccines mainly for poor countries.
If approved, the Chinese vaccines would be the first from a non-Western country to gain approval from the global health body. So far the WHO has given emergency approval to vaccines from Pfizer-BioNTech, AstraZeneca and Johnson & Johnson. It is also expected to review Moderna's shot this week.
TRIALS AND EFFICACY
No detailed efficacy data of Sinopharm’s COVID-19 vaccine has been publicly released but its developer, Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group or CNBG, said the vaccine was 79.34 percent effective in preventing people from developing the disease based on interim data.
It has been approved in several countries including China, Pakistan and the UAE.
However, the United Arab Emirates said the vaccine was 86 percent effective, according to interim results of its phase three trial.
A company spokeswoman declined to explain the discrepancy, and said detailed results would be released later, said a Reuters report.
But even ahead of the phase three trial results, the vaccine had already been distributed to nearly a million people in China under an emergency programme.
Earlier in December, Peru suspended trials for the Sinopharm vaccine due to a "serious adverse event" affecting a volunteer. It later said that it lifted the suspension.
A pause in a clinical trial is not unusual. In September, the UK paused trials for another COVID-19 vaccine after a participant had a suspected adverse reaction, resuming after the vaccine was ruled out as the cause.
The vaccine, which uses an inactivated virus unable to replicate human cells to trigger immune responses, requires two doses, past trial data has showed.
VARIANTS AND BOOSTER
Citing results from lab tests using blood samples taken from clinical trial participants, Zhang Yuntao, vice president at CNBG, said antibodies triggered by two COVID-19 vaccine products from Sinopharm both have "pretty good" neutralising effect on variants found in Britain and South Africa as well as a few others.
Some people in the UAE failed to develop sufficient antibodies after a second dose of the Sinopharm vaccine and were given a third dose, the UAE health ministry said this month. It said the number was "minimal" compared to the number of vaccines administered.
Sinopharm said the company will need to assess results from overseas Phase III clinical trials to decide whether its two-shot vaccine should be followed by a booster shot.
MADE FROM CORONAVIRUS
Sinopharm uses inactivated coronaviruses to make their vaccines — a tried-and-true method dating back over 130 years.
The company uses chemicals to disable the virus’s genes so that it cannot replicate.
Yet the inactivated coronavirus can still cause the body’s immune system to produce antibodies against it.
Experts say there are drawbacks to inactivated vaccines like the one made by Sinopharm, The New York Times reported.
The vaccine requires starting off with large batches of live coronavirus samples, which can pose a biosecurity risk, according to the report.
Once the live samples are inactivated, it takes an extra manufacturing step to ensure that none of them survive the treatment.
Last month Hungary agreed to pay about $36 per dose of Sinopharm’s vaccine, making it one of the most expensive in the world, according to The New York Times.
People who were previously vaccinated in China have said that the two-dose regimen costs about $60 to $150, the Times said.
Sinopharm has said the cost of two doses should be lower than $150.
Reuters reported that Senegal in February paid a little over $3.72 million for 200,000 doses of the Sinopharm vaccine - nearly $19 per shot.