Earlier this week, AstraZeneca PLC and the University of Oxford said their vaccine candidate was 62% to 90% effective, joining two other Western vaccine rivals in providing data. The results could allow the US and other countries to grant regulatory clearance and prepare distribution plans for widespread vaccination.
Chinese vaccine makers began late-stage clinical trials in July, around the same time as Western vaccine developers Pfizer Inc. and Moderna Inc. One reason China has to wait longer for results, experts say in public health, is that the countries where the researchers looked for volunteers – in places like the United Arab Emirates and Brazil – have not seen the spread of Covid-19 as rapidly as it has in the United States, which is the key testing ground. for major western vaccine manufacturers.
Trials must accumulate a certain number of cases of infection before researchers can justify revealing which participants received vaccines versus placebo to calculate efficacy rates.
“China has said it would make its vaccine a global public good, but we need details and accountability,” says Peter Maybarduk, director of the nonprofit Public Citizen consumer advocacy group in Washington, DC.
Chinese authorities did not wait for late-stage clinical results to start vaccines outside of trials. Almost a million Chinese have been inoculated with injections from the state-owned Sinopharm, without strong evidence of the vaccine’s efficacy, raising concern among international public health experts.
In September, the UAE went ahead with vaccinating medical workers with Chinese vaccines.
But at least one government is refraining from approving Chinese vaccines due to a lack of clinical evidence. Penny Lukito, the director of Indonesia’s food and drug authority, told lawmakers in a session last week that her agency would delay granting emergency use of a vaccine developed by private Chinese pharmaceutical company Sinovac Biotech Ltd. until the end of January, when you expect to get interim results from ongoing trials. in the country will be available.
Indonesian authorities seek to follow the UAE in approving Chinese vaccines for emergency use. The government said last month that it plans to purchase more than 100 million doses of the Sinovac vaccine, as well as tens of millions more from two other Chinese vaccine developers who have also failed to release late-stage clinical results. According to the Sinovac spokesman, the country has already received 120,000 doses of its vaccine.
Sinovac last stage tests are also underway in Brazil. The researchers who helped run that trial say they now have 74 confirmed cases of Covid-19 among the participants, enough to do an interim analysis, and they are likely to release the first results in December. A Sinovac spokesperson said the timeline for information release depends on the Brazilian team and the “scientific process”, not on “human will.”
Indonesian regulator Ms Lukito said her agency was unable to obtain clinical data from Brazil. The Sinovac clinical trial in Indonesia began in August, later than the trial in Brazil, and interim results from the Indonesian trial are expected around January.
Chinese vaccine developers have had to travel abroad to conduct clinical trials because Covid-19 has been largely under control in China for months. Its Western rivals are also conducting clinical trials abroad, although they have recruited tens of thousands of volunteers in the US and the UK, where Covid-19 has made a big impact. Chinese researchers have been excluded from those places amid growing tensions between Beijing and the West.
Pierre A. Morgon, senior vice president of international business for CanSino Biologics Inc., which is collaborating with the Chinese military on a vaccine, said companies like AstraZeneca and Pfizer have an advantage over Chinese vaccine developers in setting up international clinical trials. , because having a greater number of qualified personnel to carry out tests, as well as connections with foreign regulators. Morgon said CanSino expects to see interim results early next year and declined to comment further.
As early as May, Chinese leader Xi Jinping raised expectations that China would try to play an important role in helping the world overcome the pandemic by sharing whatever vaccines it developed. Some public health experts say the lack of robust data so far could work against Beijing’s ambitions to become the developing world’s supplier of vaccines.
“If China wants to export its vaccines as tools of diplomacy to target low-income countries, they still have to keep trying to match their good faith,” said J. Stephen Morrison, global health policy specialist at the Center for Strategic and International Studies. That means continuing to conduct clinical trials in order to provide data and a certain level of transparency, he said.
Several factors continue to favor China. A global vaccine delivery program organized by the World Health Organization and other international bodies will likely not be able to deliver vaccines to developing countries until the end of next year. Those same regions cannot compete with the US and other developed nations for first doses from Western vaccine makers, opening up an opportunity for Beijing.
Another consideration for governments, and a potential advantage for Beijing, is that China’s main candidate vaccines can be stored at regular temperatures in the refrigerator, unlike two Western candidates, one from Germany’s BioNTech SE in conjunction with Pfizer and another from Modern, which must be kept at much lower temperatures.
AstraZeneca’s vaccine, like the Chinese candidates, only requires traditional refrigeration temperatures. Gavi, the organization that helps procure vaccines for the global distribution program, expressed confidence that it could obtain hundreds of millions of doses of the vaccine from AstraZeneca after the company released promising efficacy data.
Indonesia, Mexico and Brazil are among the countries that have committed to purchasing AstraZeneca vaccines on their own. When the director of PT Bio Farma, an Indonesian state-owned vaccine producer, was asked in a recent television interview why Indonesia was not considering Pfizer and Moderna vaccines, he said that the very low temperatures required to store them would make it difficult to store them. distribution.
“If we have to use Pfizer, to give an example, or Moderna, we must make more acquisitions for storage systems that can handle extreme situations,” said Honesti Basyir, CEO of Bio Farma.
Dicky Budiman, an Indonesian epidemiologist at Griffith University in Australia, said that even if Sinovac’s results were late in coming, the vaccine could end up being very useful for Indonesia, because it would likely be cheap and did not need to be stored. at extreme temperatures.
“Our biggest challenge now is that while we wait, we have to deal with this pandemic,” Budiman said.
This story has been published from a news agency feed with no changes to the text.
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