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J&J kicks off final study of single-shot COVID-19 vaccine in 60,000 volunteers

J&J kicks off final study of single-shot COVID-19 vaccine in 60,000 volunteers

JULIE STEENHYSEN JOHNSON & Johnson has kicked off a final 60,000-person trial of a single-shot COVID-19 vaccine that potentially would simplify the distribution of millions of doses compared with leading rivals using two doses. The company expects results of the Phase III trial by year end or early next year, Dr. Paul Stoffels, J&J's chief scientific officer, said in a joint press conference with officials from the National Institutes of Health and the Trump administration. Rival vaccines from Moderna Inc, Pfizer Inc and AstraZeneca all require two shots separated by several weeks, which make them much more difficult to administer.…
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COVID-19 breakthrough: New vaccine is more than 90% effective

COVID-19 breakthrough: New vaccine is more than 90% effective

PFIZER Inc has revealed its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study, a major victory in the fight against the pandemic. Pfizer and German partner BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. Following are reactions to the news. LUCIO ROVATI, CEO OF ITALY'S ROTTAPHARM BIOTECH, WHICH IS WORKING WITH TAKIS BIOTECH ON A COVID-19 VACCINE "This is important news. Nothing that was not expected. Anyway, great, great. The problem remains that the data is limited in duration,…
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World’s first COVID-19 vaccine will be available in December in the US

World’s first COVID-19 vaccine will be available in December in the US

THE first Americans could receive a COVID-19 vaccine as soon as December 11, the chief scientific adviser for the U.S. government's vaccine program said on Sunday. "Within 24 hours from the approval, the vaccine will be moving and located in the areas where each state will have told us where they want the vaccine doses," Dr. Moncef Slaoui, part of the "Operation Warp Speed" vaccine program, told NBC's "Meet the Press." The U.S. Food and Drug Administration's outside advisers will meet on December 10 to discuss whether to authorize the COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech…
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EXPLAINER – When and how will COVID-19 vaccines become available?

EXPLAINER – When and how will COVID-19 vaccines become available?

JULIE STEENHUYZEN and CARL O’DONNELL PFIZER Inc with partner BioNTech SE and Moderna Inc have released trial data showing their COVID-19 vaccines to be about 95% effective at preventing the illness, while AstraZeneca Plc this week said its vaccine could be up to 90% effective. If regulators approve any of the vaccines in coming weeks, the companies have said distribution could begin almost immediately with governments around the world to decide who gets them and in what order. The following is an outline of the process: WHEN WILL COMPANIES ROLL OUT A VACCINE? Pfizer, Moderna and AstraZeneca have already started…
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Promise of COVID vaccines is ‘phenomenal’, WHO says

Promise of COVID vaccines is ‘phenomenal’, WHO says

STEPHANIE NEBEHAY  THE promise of COVID-19 vaccines is "phenomenal" and "potentially game-changing", Hans Kluge, the World Health Organization's regional director for Europe, told a briefing. Speaking from Copenhagen, he said supplies were expected to be very limited in the early stages and countries must decide who gets priority, though the WHO said there is "growing consensus" that first recipients should be older people, medical workers and people with co-morbidities. Britain approved Pfizer Inc's COVID-19 vaccine on Wednesday, jumping ahead of the rest of the world in the race to begin the most crucial mass inoculation programme in history. Prime Minister…
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EXPLAINER-I just got a COVID-19 vaccine. Now what?

EXPLAINER-I just got a COVID-19 vaccine. Now what?

DEENA BEASLEY BRITAIN has become the first country in the world to roll out the COVID-19 vaccine developed by Pfizer Inc and BioNTech SE, initially making the shot available at 50 hospitals. The country's National Health Service is giving priority to vaccinating people over the age of 80, frontline healthcare workers and nursing home staff and residents. The following is what people getting the vaccine should expect. WHAT HAPPENS WHEN SOMEONE GETS THE VACCINE? The vaccine, developed with new messenger RNA technology using a manufactured fragment of the coronavirus' genetic code, is injected into the arm. The inoculation is given…
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Moderna says its shot remains 93% effective

Moderna says its shot remains 93% effective

MICHAEL ERMAN MODERNA Inc has revealed that its COVID-19 shot was about 93% effective four to six months after the second dose, showing hardly any change from the 94% efficacy reported in its original clinical trial. That compares favourably to data released by rivals Pfizer Inc and BioNTech SE last week in which they suggested their vaccine's efficacy waned around 6% every two months, declining to around 84% six months after the second shot. Both the Moderna and Pfizer-BioNTech vaccines are based on messenger RNA (mRNA) technology. "We are very pleased that our COVID-19 vaccine efficacy is stable at 93%…
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Concerns mount over rival vaccines

Concerns mount over rival vaccines

CARL O’DONNELL WEALTHY governments are looking to COVID-19 shots from Pfizer Inc and Moderna Inc to keep their vaccination programs on track, as safety concerns and production problems sideline vaccines from AstraZeneca Plc and Johnson & Johnson, public health experts and industry analysts say. Countries in Europe and Asia, as well as South Africa, are limiting or halting use of AstraZeneca's shot over safety concerns. Rollout of J&J's one-shot vaccine was paused in the United States and Europe this week over a handful of cases of very rare but dangerous blood clots in the brain, much like AstraZeneca's safety issue.…
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Pfizer bets on COVID-19 vaccine demand for years, sees sales of $26-billion in 2021

Pfizer bets on COVID-19 vaccine demand for years, sees sales of $26-billion in 2021

MANAS MISHRA and MICHAEL ERMAN PFIZER Inc yesterday raised its forecast for 2021 COVID-19 vaccine sales by more than 70% to $26 billion and said demand from governments around the world trying to halt the pandemic could contribute to its growth for years to come. The company said it expects by the end of this month to file for full approval of the vaccine for people over the age of 16 in the United States, where it is currently only authorized for emergency use. It also expects to hear soon from U.S. regulators on the expansion of the vaccine's emergency…
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Booster shots: Who decides?

Booster shots: Who decides?

JULIE STEENHUYSEN and KATE KELLAND VACCINE makers Moderna Inc and Pfizer Inc, with their German partner BioNTech, have been vocal in their view that the world will soon need COVID-19 booster shots to maintain high levels of immunity. What is less clear, however, is who should make that decision - and based on what evidence. THE MODEL FOR FLU VACCINES Public health officials have a well-coordinated mechanism, first established in 1952, for determining when seasonal flu vaccines should be updated to cope with fast-mutating strains of influenza. The World Health Organization's Global Influenza Surveillance and Response System gathers data collected…
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