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Testing vaccine in pregnant women

Testing vaccine in pregnant women

JULIE STEENHUYSEN PFIZER Inc and BioNTech SE have started an international study with 4,000 volunteers to evaluate the safety and effectiveness of their COVID-19 vaccine in healthy pregnant women, the companies said on Thursday. Pregnant women are at higher risk of developing severe COVID-19, and many public health officials have recommended some women in high-risk professions take coronavirus vaccines even without proof they are safe for them. Last week, the U.S. National Institutes of Health called for greater inclusion of pregnant and lactating women in COVID-19 vaccine research. Bioethicists, vaccine and maternal health experts have argued for years that pregnant…
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WHO emergency COVID-19 vaccine listing aims to lift access in poor countries

WHO emergency COVID-19 vaccine listing aims to lift access in poor countries

JOHN MILLER THE World Health Organization on Thursday listed Pfizer and BioNTech's COVID-19 vaccine for emergency use, in a move seeking to speed access in the developing world. The United Nations health agency said it will work with regional partners to tell national health authorities about the two-dose shot and its anticipated benefits. The WHO established its emergency use listing (EUL) process to help poorer countries without their own regulatory resources quickly approve medicines new diseases like COVID-19, which otherwise could lead to delays. The WHO's review found Pfizer/BioNTech's vaccine met the "must-have" criteria for safety and efficacy benefits outweigh…
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WHO expects decisions on Pfizer, Moderna, AstraZeneca vaccines in weeks

WHO expects decisions on Pfizer, Moderna, AstraZeneca vaccines in weeks

THE World Health Organization expects to make decisions on whether to give emergency use approval to COVID-19 vaccines from Pfizer, Moderna and AstraZeneca in the coming weeks, its chief scientist has said. Soumya Swaminathan said the global health body could decide on Pfizer's vaccine candidate in the next "couple of weeks", and later said it could also review Moderna's and AstraZeneca's candidates in a few weeks. WHO approval could allow a vaccine to be deployed in some countries where national medical regulators have not yet been able to evaluate it. Swaminathan said at least 10 companies had expressed an interest…
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Here is how the world reacted to Britain’s announcement that its COVID-19 vaccine rollout will begin next week

Here is how the world reacted to Britain’s announcement that its COVID-19 vaccine rollout will begin next week

BRITAIN has become the first country in the world to approve the COVID-19 vaccine developed by U.S. drugmaker Pfizer and its German partner BioNTech and said it will be rolled out from early next week. Here are some reactions to the news: JOHN TREGONING, A READER IN RESPIRATORY INFECTIONS AT IMPERIAL COLLEGE LONDON: "This is great news and remarkable progress given the first cases were less than a year ago. It shows what progress can be made through science and innovation. The MHRA, the UK drug regulator, will have gone through all the safety data from the trials before approving…
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Oxford COVID-19 trial will look at interim Phase III data after 53 infections – investigator

Oxford COVID-19 trial will look at interim Phase III data after 53 infections – investigator

ALISTAIR SMOUT and KATE KELLAND OXFORD University will start an initial analysis of data from its late-stage trial of the experimental COVID-19 vaccine it is developing with AstraZeneca after 53 infections among its volunteers, the study's chief investigator said on Thursday. The Oxford Vaccine Group's director, Andrew Pollard, said in a media briefing there were "lots of cases" of infections in its Phase III trial in Britain, Brazil and South Africa. The first two sets of interim data from vaccine trials from Pfizer and BioNTech last week and Moderna on Monday were released after more than 90 infections among volunteers.…
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J&J starts two-dose trial of its COVID-19 vaccine candidate

J&J starts two-dose trial of its COVID-19 vaccine candidate

KATE KELLAND  JOHNSON & JOHNSON has launched a new large-scale late-stage trial to test a two-dose regimen of its experimental COVID-19 vaccine and evaluate potential incremental benefits for the duration of protection with a second dose. The U.S. drugmaker plans to enrol up to 30,000 participants for the study and run it in parallel with a one-dose trial with as many as 60,000 volunteers that began in September. The UK arm of the study is aiming to recruit 6,000 participants and the rest will join from other countries with a high incidence of COVID-19 cases such as the United States,…
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South Africa should aim to cover 10% of population via COVAX, advisors say

South Africa should aim to cover 10% of population via COVAX, advisors say

ALEXANDER WINNING SOUTH Africa should aim to cover 10% of its population via a global coronavirus vaccine scheme while also negotiating directly with manufacturers, a group of experts has advised the government. South Africa has recorded the most novel coronavirus infections of any African nation. While it has publicly expressed support for the COVAX scheme co-led by the World Health Organization, it has yet to make the formal commitment confirming its participation. The race to secure enough vaccines to protect at-risk groups is heating up following Monday's announcement by Pfizer that its vaccine candidate is more than 90% effective based…
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‘Great day for humanity’: Pfizer says COVID-19 vaccine over 90% effective

‘Great day for humanity’: Pfizer says COVID-19 vaccine over 90% effective

MICHAEL ERMAN and JULIE STEENHUYSEN PFIZER Inc's experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said, a major victory in the war against a virus that has killed over a million people and battered the world's economy. Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year. Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek U.S.…
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Kenya joins global trial of Oxford University’s COVID-19 vaccine

Kenya joins global trial of Oxford University’s COVID-19 vaccine

KENYA has joined the global clinical trial of Oxford University's vaccine candidate against the new coronavirus, the state medical research institute has announced. The vaccine candidate, known as ChAdOx1 nCoV-19, has been developed jointly with AstraZeneca and is being evaluated in four countries: Britain, South Africa, Brazil and now Kenya. "To ensure that Kenyans can benefit... if it proves to be successful, it is important to assess its performance among Kenyan volunteers," the Kenya Medical Research Institute (KEMRI) said in a statement. KEMRI has already vaccinated the first volunteers after receiving the receiving the required regulatory and ethical approvals, it…
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