Vaccine trial updates: 1,500 Filipinos join Chinese firm’s COVID-19 vaccine study

MANILA: About 1,500 Filipinos participated in Chinese biotech company Sinopharm’s COVID-19 vaccine Phase 3 trial in the UAE, Chinese Ambassador to the Philippines Huang Xilian said.

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Huang said the 1,500 Filipinos are part of the 30,000 volunteers who joined the trials launched in the UAE, the Philippine Daily Inquirer reported on Thursday, quoting an embassy statement.

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“Around 1,500 Filipinos among more than 30,000 volunteers have participated in the Phase-III clinical trial of Sinopharm’s COVID-19 vaccine candidate in the UAE since June 23,” a statement from the Embassy said Wednesday, quoting Huang.

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The UAE trial is the world’s first Phase-III clinical trial of a COVID-19 inactivated vaccine. Apart from UAE, Huang said trials of the same vaccine are also ongoing in Bahrain, Argentina, Peru, and Morocco and more, involving some 50,000 volunteers.

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WHO says $700 million raised so far for COVID-19 vaccines initiative for poor

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HARARE: International donors have raised $700 million – less than half the target – to purchase future coronavirus vaccines for poor countries in a global initiative to ensure eventual vaccines do not go only to rich countries, a World Health Organization official said on Thursday.

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The COVAX Advanced Market Commitment has an initial target of $2 billion to buy the vaccines.

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“Up to today, what has been mobilised so far is $700 million … So there is a great deal of work to be done to diversify the possible sources of funding,” Matshidiso Moeti, Africa regional director for the WHO, told an online press briefing.

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COVAX is co-led by the GAVI Vaccine Alliance, the WHO and the CEPI Coalition for Epidemic Preparedness Innovations. Its aim is to deliver 2 billion doses of effective, approved COVID-19 vaccines by the end of 2021.

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At least eight African countries, including South Africa, Gabon, Namibia and Equatorial Guinea had agreed to self-finance access to the vaccine, Moeti said.

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The Africa Centres for Disease Control and Prevention said last month the continent had started to slowly “bend the curve” of COVID-19 infections as measures like mask-wearing and social distancing slow the spread of the pandemic.

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Vaccine still possible this year, despite trial pause: AstraZeneca

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LONDON: Drugs giant AstraZeneca on Thursday said a Covid-19 vaccine could still be available by as early as the end of this year, despite a randomised clinical trial in the UK being paused.

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“We could still have a vaccine by the end of this year, early next year,” the company’s chief executive Pascal Soriot said, adding it depended on how fast regulators moved.

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Brazil could launch Chinese vaccine this 2020: governor

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SAO PAULO: Clinical trials in Brazil of a Chinese-made vaccine against COVID-19 have shown “extremely positive” results, and a widespread vaccination campaign could begin as early as December, the governor of Sao Paulo state said.

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Sao Paulo, the epicenter of the coronavirus pandemic in hard-hit Brazil, is one of six states helping to test the so-called CoronaVac vaccine developed by Chinese pharmaceutical firm Sinovac Biotech.

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The vaccine produced an immune response in 98 percent of recipients over 60 years old, with no adverse side-effects reported so far, said Governor Joao Doria.

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“The results have been extremely positive,” he told a news conference.

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“We will soon be able to immunize Brazilians in Sao Paulo and across the country with the CoronaVac vaccine…The projected delivery date is in December this year.”

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Sinovac has partnered with a Brazilian public health research center, the Butantan Institute, to conduct Phase 3 clinical trials of the vaccine — the last step before regulatory approval.

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The deal gives the institute the right to produce 120 million doses of the vaccine, according to officials. CoronaVac has gotten caught up in a political battle in Brazil, however.

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Vaccine criticised

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President Jair Bolsonaro, whose administration has tense relations with China, has criticized the vaccine, and lashed out at Doria, a leading opponent, for supposedly backing it.

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The far-right president has instead allocated 1.9 billion reals ($360 million) to purchase another vaccine candidate, developed by Oxford University and pharmaceutical firm AstraZeneca.

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Brazil has the third-highest death toll in the pandemic after the United States and India, with more than 127,000 people killed and 4.1 million infections.

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The South American country has emerged as a leading testing ground for vaccines. In the latest development, Brazilian medical diagnostics company Dasa and US vaccine-maker COVAXX announced a deal Wednesday to conduct Phase 2 and 3 trials of the latter’s Covid-19 vaccine in Brazil. COVAXX, a subsidiary of US firm United Biomedical, plans to test the vaccine on at least 3,000 volunteers in Brazil.

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Chinese vaccine trial in Pakistan

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ISLAMABAD: Phase 3 clinical trial in Pakistan for a potential vaccine being developed by China’s CanSino Biologics is expected to begin this month, according to officials running the trial.

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The falling Covid-19 infection numbers in Pakistan will not affect the trial in Pakistan, said health officials. Islamabad’s drug regulator last month gave the go-ahead for the country’s first Phase 3 clinical trial for CanSino’s candidate, Ad5-nCoV, which will be led by the government-run National Institute of Health (NIH) along with pharmaceutical company AJM — the local representative of CanSino.

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“We are planning to launch the project on September 20, or at the latest within this month,” Hassan Abbas Zaheer, who is heading the trial for AJM, told Reuters.

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The Ad5-nCoV vaccine and placebo injections are due to be received in Pakistan next week. Daily positive cases in Pakistan peaked at more than 6,000 in June, but have since fallen sharply, with only 426 confirmed new cases detected on September 8 – taking its total to 299,659 and 6,359 deaths.

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Zaheer said the low positive rates did not indicate COVID-19 was no longer present in the country, and the potential for people vaccinated in the trial to be infected was still adequate for testing their immunity. pakistan, a country of more than 220 million people, has been testing between 20,000 to 30,000 daily.

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Russia starts giving new virus vaccine to volunteers in Moscow

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MOSCOW: Russia began inoculating volunteers in Moscow with the country’s new coronavirus vaccine, the capital’s deputy mayor said. Russia announced last month that its vaccine, named “Sputnik V” after the Soviet-era satellite that was the first launched into space in 1957, had already received approval.

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“The first participants have already had the vaccination at clinics in the capital,” Deputy Mayor Anastasia Rakova, responsible for social development, said in a statement.

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The vaccine project is financed by Russia’s sovereign wealth fund, the Russian Direct Investment Fund. The vaccine was developed by the Gamaleya research institute in Moscow in coordination with the Russian defence ministry.

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High-profile Russians have already been vaccinated, including President Vladimir Putin’s daughter, nationalist politician Vladimir Zhirinovsky and Moscow Mayor Sergei Sobyanin. Putin’s spokesman Dmitry Peskov said Wednesday that the president would “inform you about it himself” if he decided to get vaccinated.

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The Moscow city government website said 40,000 people from the capital can receive the vaccine, given in two doses with a 21-day interval. The site says they are taking part in a “post-registration study” of the vaccine.

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Russian coronavirus vaccine produces immune response in early trials

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  • None of the participants developed serious adverse reactions.
  • Trial data released weeks after Russia announced that it had approved its vaccine for the general population

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A coronavirus vaccine candidate developed in Russia prompted an immune response and didn’t cause serious adverse reactions in early trials, according to new data, LiveScience reported.

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This data was released weeks after Russia announced that it had approved its vaccine for the general population (but had actually only approved it for a small group of people), drawing criticism from public health experts who said there was not enough data to prove the vaccine was safe and effective.

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Vaccines won’t be ‘silver bullet’ for staging Olympics

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  • IOC president Thomas Bach says progress with vaccines and rapid testing for COVID-19 will not be the complete answer for staging the Tokyo Olympics
  • Japanese public has been skeptical about the July 23-Aug. 8 games going ahead

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LAUSANNE, Switzerland: Amid uncertainty about planning the Tokyo Olympics, IOC president Thomas Bach said Wednesday that progress with vaccines and rapid testing for COVID-19 would not be the complete answer for staging the rescheduled games.

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“They will not be the silver bullet but they can greatly facilitate the organization of the games,” Bach said at a news conference after an International Olympic Committee board meeting.

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While the Japanese public has been skeptical about the July 23-Aug. 8 games going ahead, Olympic Minister Seiko Hashimoto said this week “I feel we have to hold them no matter what.”

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Bach declined Wednesday to speculate on the Tokyo Olympics being held without fans in the venues as has become the global reality for sports in 2020.

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“We don’t know how the world looks like tomorrow,” Bach said. “So how can you expect from us to know how the world looks in 320 days from today?”

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Halted vaccine trial shows ‘no compromises’ on safety: NIH

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  • The National Institutes of Health director is telling Congress that AstraZeneca’s suspension of its COVID-19 vaccine study shows there will be “no compromises” on safety in developing the shots
  • AstraZeneca has put on hold studies of its vaccine candidate in the US
  • Trial pause also covers other countries while it investigates whether a British volunteer’s illness is a side effect or a coincidence.

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WASHINGTON: The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be “no compromises” on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday.

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AstraZeneca has put on hold studies of its vaccine candidate in the US and other countries while it investigates whether a British volunteer’s illness is a side effect or a coincidence.

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“This ought to be reassuring,” NIH Director Dr. Francis Collins said before a Senate committee. “When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.”

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The US has launched some of the world’s largest studies — final-stage testing of three leading candidates, with three more trials set to come soon that will each recruit 30,000 test subjects.

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Public health experts are worried that President Donald Trump will pressure the Food and Drug Administration to approve a vaccine before it is proven to be safe and effective, a concern senator after senator echoed on Wednesday.

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“When it comes to a COVID-19 vaccine, we can’t allow President Trump to repeat his alarming pattern of putting politics ahead of science and public health,” said Sen. Patty Murray of Washington, the committee’s ranking Democrat.

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The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective could be disastrous, derailing the effort to vaccinate millions of Americans.

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Collins said the public needs to understand the process behind telling when any vaccine candidate is ready for widespread use — one that by design is keeping both manufacturers and politicians in the dark until the evidence gels.

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About 150 COVID-19 infections in a study of 30,000 people should be enough to tell if that candidate really is working — and an independent group of experts, not the FDA, gets to do the counting.

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Who monitors the studies? 

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Every vaccine trial is overseen by a “data and safety monitoring board,” or DSMB. These boards include scientists and statisticians who are experts in their fields but have no ties to either the government or the vaccine makers.

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The top priority: watching for safety concerns, like the one that sparked a DSMB in Britain to pause AstraZeneca’s vaccinations and alert its U.S. counterpart.

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But this is the group that also will decide when each vaccine is ready to be evaluated by regulators.

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In each 30,000-person study, about half the participants are given the real vaccine and half get dummy shots, and neither they nor their doctors know which is which. Only the DSMB has the power to unlock the code of who got which shot and peek at how the volunteers are faring before a study is finished.

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The FDA can’t even begin to consider approving a vaccine until the DSMB says the data is good enough for that debate, Collins stressed. Once that happens, the FDA has pledged to bring each candidate before a public vaccine advisory committee.

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Doing the math

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The FDA already has told manufacturers it won’t consider any vaccine that’s less than 50% effective.

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Say one vaccine trial records that 150 volunteers have gotten sick. The DSMB finds that 100 had received dummy shots and 50 had received the real vaccine. The expert group might decide that’s a promising enough vaccine to stop the study early so that the FDA can debate its merits, even before getting final outcomes from all 30,000 volunteers, said Dr. Larry Corey of the Fred Hutchinson Cancer Research Institute, who is overseeing the U.S. government’s vaccine studies.

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On the other hand, if equal numbers from the vaccine and placebo groups got infected, the DSMB might declare a vaccine futile, he told The Associated Press. These panels also can calculate infections even before that 150 threshold is met, at set time points in each study.

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“If your vaccine is at least 50% effective, you’re going to know it because you’re going to see a big skewing” of infections, NIH’s Collins told the Senate’s health, education, labor and pensions committee. “You count those events and you know whether it worked or not.”

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Answers unlikely before the US election

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Getting the right math before November, as Trump has promised, is “incredibly unlikely”, Corey said.

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Collins expressed “cautious optimism” that one of the vaccines being tested will pan out by the end of the year but warned: “Certainly to try to predict whether it happens on a particular week before or after a particular date in early November is well beyond anything that any scientist right now could tell you.”

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And even if a study has a spate of infections large enough to prove the effectiveness question, the DSMB also must be comfortable that there’s enough evidence of safety before opening the books to the FDA. Generally, the FDA is requiring safety data from at least 3,000 people, Surgeon General Jerome Adams told the Senate panel.

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This process isn’t new — Phase 3 studies of vaccines and therapies are always done this way, though rarely in so bright a spotlight.

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Suspending study not that rare 

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It’s not uncommon for pauses in research to investigate whether an unexpected health complaint is really related to a vaccine or not, Collins told senators worried about what the AstraZeneca suspension means for the nation’s year-end goal.

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“The reason we’re investing not in one but six different vaccines is because of the expectation that they won’t all work,” Collins said.

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AstraZeneca gave no details on the illness, but Collins said it involved a “spinal cord problem”. Earlier-stage studies hadn’t revealed any serious side effects, but that’s a key reason for doing ever-larger phases of research — to widen the search for any reactions.

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Final testing of two other vaccines is continuing, one created by the NIH and manufactured by Moderna Inc., the other made by Pfizer and Germany’s BioNTech. Those two vaccines work differently than AstraZeneca’s, and the studies already have recruited about two-thirds of the needed volunteers.

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Several vaccine candidates made by Chinese companies are in late stages of testing in various countries, but with smaller numbers of volunteers. Most health authorities are skeptical about a claim of vaccine success by Russia, which has test results from just a few dozen people.

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He asked athletes to accept any demands made of them in traveling to and staying in Japan next year.

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“Nobody can just look at him or herself and say ‘I do not want this’ or ‘I don’t think this is fair’. You have to show solidarity there in order to fight the virus,” Bach said. “If you need a quarantine to ensure a safe environment for all the participants of the games, then you need to go to quarantine.”

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