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TAIPEI—Pressure is mounting on Chinese drugmakers to show clinical evidence that their leading Covid-19 vaccines work, after early data on three Western-developed shots showed promising effectiveness against the disease.
Earlier this week, AstraZeneca PLC and the University of Oxford said their vaccine candidate was anywhere between 62% to 90% effective, joining two other Western vaccine rivals in providing data. The results could allow the U.S. and other countries to grant regulatory authorization and gear up distribution plans for widespread vaccination.
Chinese vaccine makers kicked off late-stage clinical trials in July, around the same time as Western vaccine developers Pfizer Inc. andModerna Inc. One reason China is having to wait longer for results, public health experts say, is that the countries where Chinese researchers sought out volunteers—in places such as the United Arab Emirates and Brazil—haven’t seen Covid-19 spread as quickly of late as it has in the U.S., which is the key testing ground for leading Western vaccine makers.
Trials need to accumulate a certain number of infection cases before researchers can justify revealing which participants received vaccines versus a 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 at nonprofit consumer advocacy group Public Citizen in Washington, D.C.
Chinese authorities didn’t wait for late-stage clinical results to begin vaccinations outside of trials. They have inoculated nearly one million Chinese people with shots by state-owned Sinopharm, without solid evidence of the vaccine’s efficacy, raising concerns from international public health experts.
In September, the U.A.E. went ahead in vaccinating medical workers with Chinese vaccines.
But at least one government is holding back from approving Chinese vaccines because of the lack of clinical evidence. Penny Lukito, head 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 Chinese private drugmaker Sinovac Biotech Ltd. until late January, when it hopes interim results from ongoing trials in the country will be available.
Indonesian authorities are looking to follow the U.A.E. by approving Chinese vaccines for emergency use. The government said last month it plans to procure more than 100 million doses of Sinovac’s vaccine, as well as tens of millions more from two other Chinese vaccine developers that also haven’t released late-stage clinical results. According to Sinovac’s spokesman, the country has already received 120,000 doses of its vaccine.
Sinovac’s late-stage trials are also under way in Brazil. Researchers helping run that trial say they now have 74 confirmed Covid-19 cases among participants, enough to do an interim analysis, and that they are likely to release early results in December. A Sinovac spokesman said the timeline for releasing information depends on the Brazilian team and “scientific process,” not “human willingness.”
The Indonesian regulator Ms. Lukito said her agency wasn’t able to get clinical data from Brazil. Sinovac’s 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 go abroad to conduct clinical trials because Covid-19 has been mostly under control within China for months. Their Western rivals are running clinical trials abroad too, although they’ve recruited tens of thousands of volunteers in the U.S. and U.K., where Covid-19 has hit hard. Chinese researchers have been shut out from such places amid rising tensions between Beijing and the West.
Pierre A. Morgon, senior vice president for international business at CanSino Biologics Inc., which is collaborating with the Chinese military on a vaccine, said firms like AstraZeneca and Pfizer have an edge over Chinese vaccine developers in setting up international clinical trials, because they have a greater number of skilled staff for running trials as well as connections with foreign regulators. Mr. 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 a major role in helping the world get over the pandemic by sharing any vaccine it developed. Some public health experts say the lack of solid data so far could work against Beijing’s ambitions to become the developing world’s vaccine provider.
“If China wants to export its vaccine as tools of diplomacy to target low-income countries, they’ve still got to keep trying to get their bona fides up to snuff,” said J. Stephen Morrison, a global health policy specialist at the Center for Strategic and International Studies. That means continuing to run clinical trials to be able to offer up data and some level of transparency, he said.
A number of factors remain in China’s favor. A global vaccine delivery program organized by the World Health Organization and other international bodies likely won’t be able to supply vaccines to developing countries until late next year. Those same regions can’t compete with the U.S. and other developed nations to secure early doses from Western vaccine makers, opening an opportunity for Beijing.
Another consideration for governments—and a potential advantage for Beijing—is that China’s leading vaccine candidates can be stored at regular fridge temperatures, unlike two Western candidates, one by Germany’sBioNTech SE along with Pfizer and another by Moderna, that need to be kept at much lower temperatures.
AstraZeneca’s vaccine, like the Chinese candidates, requires only traditional refrigeration temperatures. Gavi, the organization helping procure vaccines for the global distribution program, expressed confidence that it could get hundreds of millions of doses of AstraZeneca’s vaccine supplied after the firm released promising efficacy data.
Indonesia, Mexico, and Brazil are among countries that have engaged to buy AstraZeneca vaccines on their own. When the head of PT Bio Farma, an Indonesian state-owned vaccine producer, was asked in a recent television interview why Indonesia wasn’t considering vaccines from Pfizer and Moderna, he said the very low temperatures required to store them would make distribution difficult.
“If we have to use Pfizer, to give an example, or Moderna, we must make further procurements for storage systems that can handle extremes,” Honesti Basyir, Bio Farma’s chief executive, said.
Dicky Budiman, an Indonesian epidemiologist at Griffith University in Australia, said even if results from Sinovac took time to arrive, the vaccine could still end up being very useful for Indonesia, because it was likely to be cheap and didn’t need to be stored at extreme temperatures.
“Our biggest challenge now is while we wait, we have to deal with this pandemic,” Mr. Budiman said.
https://www.wsj.com/articles/china-...rove-their-covid-19-vaccines-work-11606309143
Earlier this week, AstraZeneca PLC and the University of Oxford said their vaccine candidate was anywhere between 62% to 90% effective, joining two other Western vaccine rivals in providing data. The results could allow the U.S. and other countries to grant regulatory authorization and gear up distribution plans for widespread vaccination.
Chinese vaccine makers kicked off late-stage clinical trials in July, around the same time as Western vaccine developers Pfizer Inc. andModerna Inc. One reason China is having to wait longer for results, public health experts say, is that the countries where Chinese researchers sought out volunteers—in places such as the United Arab Emirates and Brazil—haven’t seen Covid-19 spread as quickly of late as it has in the U.S., which is the key testing ground for leading Western vaccine makers.
Trials need to accumulate a certain number of infection cases before researchers can justify revealing which participants received vaccines versus a 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 at nonprofit consumer advocacy group Public Citizen in Washington, D.C.
Chinese authorities didn’t wait for late-stage clinical results to begin vaccinations outside of trials. They have inoculated nearly one million Chinese people with shots by state-owned Sinopharm, without solid evidence of the vaccine’s efficacy, raising concerns from international public health experts.
In September, the U.A.E. went ahead in vaccinating medical workers with Chinese vaccines.
But at least one government is holding back from approving Chinese vaccines because of the lack of clinical evidence. Penny Lukito, head 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 Chinese private drugmaker Sinovac Biotech Ltd. until late January, when it hopes interim results from ongoing trials in the country will be available.
Indonesian authorities are looking to follow the U.A.E. by approving Chinese vaccines for emergency use. The government said last month it plans to procure more than 100 million doses of Sinovac’s vaccine, as well as tens of millions more from two other Chinese vaccine developers that also haven’t released late-stage clinical results. According to Sinovac’s spokesman, the country has already received 120,000 doses of its vaccine.
Sinovac’s late-stage trials are also under way in Brazil. Researchers helping run that trial say they now have 74 confirmed Covid-19 cases among participants, enough to do an interim analysis, and that they are likely to release early results in December. A Sinovac spokesman said the timeline for releasing information depends on the Brazilian team and “scientific process,” not “human willingness.”
The Indonesian regulator Ms. Lukito said her agency wasn’t able to get clinical data from Brazil. Sinovac’s 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 go abroad to conduct clinical trials because Covid-19 has been mostly under control within China for months. Their Western rivals are running clinical trials abroad too, although they’ve recruited tens of thousands of volunteers in the U.S. and U.K., where Covid-19 has hit hard. Chinese researchers have been shut out from such places amid rising tensions between Beijing and the West.
Pierre A. Morgon, senior vice president for international business at CanSino Biologics Inc., which is collaborating with the Chinese military on a vaccine, said firms like AstraZeneca and Pfizer have an edge over Chinese vaccine developers in setting up international clinical trials, because they have a greater number of skilled staff for running trials as well as connections with foreign regulators. Mr. 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 a major role in helping the world get over the pandemic by sharing any vaccine it developed. Some public health experts say the lack of solid data so far could work against Beijing’s ambitions to become the developing world’s vaccine provider.
“If China wants to export its vaccine as tools of diplomacy to target low-income countries, they’ve still got to keep trying to get their bona fides up to snuff,” said J. Stephen Morrison, a global health policy specialist at the Center for Strategic and International Studies. That means continuing to run clinical trials to be able to offer up data and some level of transparency, he said.
A number of factors remain in China’s favor. A global vaccine delivery program organized by the World Health Organization and other international bodies likely won’t be able to supply vaccines to developing countries until late next year. Those same regions can’t compete with the U.S. and other developed nations to secure early doses from Western vaccine makers, opening an opportunity for Beijing.
Another consideration for governments—and a potential advantage for Beijing—is that China’s leading vaccine candidates can be stored at regular fridge temperatures, unlike two Western candidates, one by Germany’sBioNTech SE along with Pfizer and another by Moderna, that need to be kept at much lower temperatures.
AstraZeneca’s vaccine, like the Chinese candidates, requires only traditional refrigeration temperatures. Gavi, the organization helping procure vaccines for the global distribution program, expressed confidence that it could get hundreds of millions of doses of AstraZeneca’s vaccine supplied after the firm released promising efficacy data.
Indonesia, Mexico, and Brazil are among countries that have engaged to buy AstraZeneca vaccines on their own. When the head of PT Bio Farma, an Indonesian state-owned vaccine producer, was asked in a recent television interview why Indonesia wasn’t considering vaccines from Pfizer and Moderna, he said the very low temperatures required to store them would make distribution difficult.
“If we have to use Pfizer, to give an example, or Moderna, we must make further procurements for storage systems that can handle extremes,” Honesti Basyir, Bio Farma’s chief executive, said.
Dicky Budiman, an Indonesian epidemiologist at Griffith University in Australia, said even if results from Sinovac took time to arrive, the vaccine could still end up being very useful for Indonesia, because it was likely to be cheap and didn’t need to be stored at extreme temperatures.
“Our biggest challenge now is while we wait, we have to deal with this pandemic,” Mr. Budiman said.
https://www.wsj.com/articles/china-...rove-their-covid-19-vaccines-work-11606309143
