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Pfizer Inc and BioNTech Se plan to give volunteers who received a placebo in its Covid-19 vaccine trial an option to receive a first dose of the vaccine by 1 March 2021, while staying within the study, Reuters reports.
The trialâ€™s Vaccine Transition Option allows all participants aged 16 or older the choice to discover whether they were given the placebo, â€œand for participants who learn they received the placebo, to have the option to receive the investigational vaccine while staying in the study,â€ the companies said on their website.
The US Food and Drug Administration (FDA) and a panel of its outside advisers have expressed concerns over Pfizerâ€™s â€œunblindingâ€ plan, saying it could make it harder to continue collecting data on safety and effectiveness needed to win full FDA approval of the vaccine.
Trial participants who received the placebo will have two doses of the investigational vaccine reserved for them within the study, the companies said on the website.
â€œThe study doctor will follow the latest guidance from the US Centers for Disease Control and Prevention and their local health authorities to offer the Vaccine Transition Option to participants in a prioritized manner,â€ the companies said.
Dr Anthony Fauci, the USâ€™s top infectious disease expert, has told CNN on Friday that the United States would not follow the UKâ€™s lead in front-loading first vaccine injections, potentially delaying the administration of second doses.
This week the UK announced plans to delay second shots of its two authorised vaccines, developed by Pfizer/BioNTech and Oxford/AstraZeneca, in an attempt to dole out to more people the partial protection conferred by a single dose.
â€œI would not be in favour of that,â€ Dr Fauci said. â€œWeâ€™re going to keep doing what weâ€™re doing.â€
While clinical trials tested the efficacy of second doses delivered three or four weeks after the first, UK officials said they would allow a gap of up to 12 weeks. Such delays have not been rigorously tested in trials. The Pfizer vaccine, for instance, was shown to be 95% effective at preventing Covid-19 when administered as two doses, three weeks apart.
Widening the gap between vaccine doses could risk blunting the benefits of the second shot, which is intended to boost the bodyâ€™s defences against the coronavirus, increasing the strength and durability of the immune response. In the interim, the protective effects of the first shot could also wane faster than anticipated.
The New York Times (paywall) has the story.
About two million doses of Covid-19 vaccine developed by Oxford University and AstraZeneca are set to be supplied every week by the middle of January in the UK, The Times reports.
AstraZeneca expects to supply two million doses of the vaccine in total by next week, the newspaper reported, citing an unnamed member of the Oxford/AstraZeneca team. â€œThe plan is then to build it up fairly rapidly â€“ by the third week of January we should get to two million a week,â€ the report added.
The company was not immediately available to respond to a Reuters request for comment.
The report comes after the UK on Wednesday approved the Oxford/AstraZeneca Covid-19 vaccine, hoping that rapid action will help it stem a record surge of infections driven by a highly contagious form of the virus.
The prime minister Boris Johnson has ordered 100 million doses for the country as part of an agreement with AstraZeneca. The company had said it aims to supply millions of doses in the first quarter, adding that first vaccinations are slated to begin this year.
The UK, which has recorded more than 50,000 new daily cases of Covid-19 for the last four days, is dealing with a rapid spread of a much more infectious variant of the coronavirus. As of Friday, the UK has recorded 53,285 new Covid-19 cases and another 613 deaths.
Brazil reported another 24,605 confirmed cases of coronavirus in the past 24 hours, and 462 deaths from Covid-19, the health ministry said on Friday. The country has now registered 7,700,578 cases since the pandemic began, while the official death toll has risen to 195,411, according to ministry data, in the worldâ€™s third worst outbreak outside the United States and India.
What difference will the Oxford/AstraZeneca vaccine make in the UK? In this Guardian explainer, our health editor Sarah Boseley answers some frequently asked questions about how the introduction of a new vaccine in the fight against Covid-19 will work.
The French health ministry reported 19,348 new coronavirus infections over the past 24 hours on Friday, slightly less than Thursdayâ€™s 19,927 and well below Wednesdayâ€™s more than one-month high of 26,457, but still far from the governmentâ€™s target of less than 5,000 daily additional infections.
Franceâ€™s cumulative total of cases now stands at 2,639,773, the fifth highest in the world. The Covid-19 death toll was up by 133 at 64,765.
- All primary schools in London are set to close for the start of the new term after the UK government bowed to protests and legal pressure from local authorities amid surging infection rates. The U-turn comes after the government omitted several London areas where Covid-19 transmission rates remain high from a list of education authorities where primary schools would be closed to most pupils for the first two weeks of term. Following protest from local authority leaders, including threats of unilateral closure and legal action, and an emergency cabinet meeting, the education secretary Gavin Williamson was forced to backtrack, adding the remaining 10 London education authorities to the governmentâ€™s contingency areas.
- The United States became the first country to pass 20 million lab-confirmed Covid-19 cases, though the true number of infections is thought to be much higher. Back in June, US public health experts said they believed more than 20 million Americans could have contracted the respiratory virus â€“ 10 times more than official counts at the time. Almost 350,000 Americans have now died of Covid-19, according to a Johns Hopkins University tally, by far the worldâ€™s highest death toll.
- Arrivals to Turkey from the UK have been temporarily suspended after 15 confirmed cases of the Covid-19 variant, the countryâ€™s minister of health announced.
- Ireland plans to end a ban on travel to the country from Great Britain on 6 January and replace it with stricter testing measures as it seeks to stop the spread of the new variant of the virus, the foreign minister said. Passengers flying on non-essential business from Britain after that date will need to produce a negative test taken three days before their flight. They will also be asked to restrict their movements for at least five days from their arrival and can move freely only if they then receive a second negative test.
- The UK recorded a further 613 Covid-related deaths since yesterday, after one of the highest daily tolls since April earlier this week of 981. It also registered 53,285 new cases in the last 24 hours, similar to the figure in previous days, as the number of lab-confirmed cases rises above 2.5 million.
- France will impose an earlier curfew in 15 north-east and south-east departments from Saturday to combat the spread of coronavirus, starting at 6pm instead of 8pm.
- The Philippines is to ban visitors coming from the US from entering the country from 3 to 15 January as an additional measure to contain the spread of the new, more contagious coronavirus variant.
- Indiaâ€™s drug regulator approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, paving the way for its rollout in the worldâ€™s second worst affected country. India wants to start administering the shots soon. It is also considering emergency-use authorisation applications for vaccines made by Pfizer Inc with Germanyâ€™s BioNTech, and by Indiaâ€™s Bharat Biotech. At more than 10 million, India has reported the second highest number of coronavirus cases after the US, though its rate of infection has come down significantly from a mid-September peak.
- Norway will lift its ban on flights arriving from the UK, the Norwegian health ministry said. Flights will resume on 2 January at 4pm GMT.
Ireland said on Friday it had under-reported coronavirus cases in recent days by thousands more than previously known as its system came under strain, suggesting the EUâ€™s fastest growing outbreak is worsening even more rapidly than figures showed.
More than 9,000 people who have tested positive for Covid-19 have yet to been added to the official tally of confirmed cases, the National Public Health Emergency Team said. A day earlier it had estimated the number of positive tests still pending registration at just 4,000.
Ireland has gone from having the lowest infection rate in the European Union just two weeks ago to having the fastest rate of deterioration, after shops and large parts of the hospitality sector were allowed to reopen for most of December.
A very large volume of positive tests since Christmas has led to a delay in positive swabs being formally confirmed as new individual cases. Ireland formally reported a daily record 1,754 confirmed cases on Friday, surpassing 1,500 daily cases for the fourth day in a row.
Senator Mitt Romney on Friday urged the US government to immediately enlist veterinarians, combat medics and others in a sweeping proposal to administer coronavirus vaccinations and slow the rising death toll.
The 2012 Republican presidential nominee called for action after it emerged that 2.8 million Americans had received their first dose, far short of the 20 million the Trump administration promised by the end of 2020.
â€œThat comprehensive vaccination plans have not been developed at the federal level and sent to the states as models is as incomprehensible as it is inexcusable,â€ Romney said in a statement.
More than 345,000 people have died from Covid-19 in the United States, equal to one in every 950 people and ranking 16th in per capita deaths in the world. Meanwhile, the US was set to pass another milestone on Friday, surpassing 20 million cases since the start of the pandemic with a record number of 125,000 patients in hospital with Covid-19.
With the Democratic president-elect Joe Biden not taking office until 20 January, Romney is one of the few leading Republicans to openly criticise fellow Republican President Donald Trump.
Romney called for deploying veterinarians, emergency medical workers and medical students to deliver vaccinations and setting up sites such as school buildings that are largely empty because of the pandemic.
He also recommended establishing a clear order for Americans to receive their shots using priority groups and birthdays, while welcoming other ideas from medical professionals.
Trump has repeatedly emphasised that he, not Biden, deserves credit for the speedy development of the vaccine, even as he has left vaccination efforts largely to US state and local officials to administer with the help of private pharmacies.
The states and localities, already hammered by the months-long fight against the outbreak and its economic fallout, only recently received federal money for vaccinations under the latest relief passage signed into law on Sunday.
Trump has spent the weeks since his 3 November loss rarely focusing, at least in public, on the worsening pandemic. Instead, he has alleged widespread election fraud, without evidence, while claiming falsely that he won the election.
Romney said the country needed to acknowledge the current plan â€œisnâ€™t workingâ€ and was â€œwoefully behind,â€ and that leaders must urgently find ways to quickly bolster capacity.
It was unrealistic to assume that the healthcare workers already overburdened with Covid care could take on a massive vaccination program.
Biden has vowed to use the Defense Production Act to boost the vaccination program and to send mobile vaccination units to help deliver shots in under-served areas.
As of midnight on Thursday, the United States had reported 19.91 million cases, according to a Reuters tally of official data.
Some residents of Mexico City spent New Yearâ€™s Eve in lines that snaked down a street and around a corner, waiting to refill oxygen canisters for relatives suffering from Covid-19, AP reports.
The city of 9 million has seen a surge in coronavirus infections and hospitals are 87% occupied, straining oxygen supplies.
That has resulted in long lines and price hikes that make it hard or impossible for some to refill tanks that, in some cases, last for only a few hours.
Blanca Nina MÃ©ndez Rojas was waiting in line Thursday to refill a tank for her brother, who was recently discharged from a public hospital after contracting Covid-19.
â€œWe just left him disconnected [from oxygen], so he has to stay completely reclined so he wonâ€™t get agitated or have a problem, until we return with the tank,â€ MÃ©ndez Rojas said, noting â€œtwo weeks ago a refill cost 70 pesos ($3.50), and now it is 150 pesos ($7.50)â€.
In a city where people are afraid to go to hospitals, and where those that will go have trouble finding a bed, it becomes a question of life and death.
Juan JosÃ© Ledesma, a Mexico City retiree, got sick along with his wife and son. When his test came back positive on 16 December, he had to stay home â€” and consult a private doctor â€” because the local hospital had no room.
â€œI have been taking medication prescribed by a private doctor because what happened was we went to a health centre and there was no room,â€ Ledesma said. â€œThere was no room because too many people were coming inâ€ for treatment.
Since then, his son, who recovered, has had to go out three or four times every day to try to refill his fatherâ€™s oxygen tank.
â€œThe price has risen two or three times,â€ Ledesma said. Reflecting on the problem, he began to weep softly. â€œI think about rural areas, where things are tougher, tougher, and people have to wait longer, or they really canâ€™t afford it.â€
IvÃ¡n, an employee of one oxygen refill store who gave only his first name because his bosses hadnâ€™t authorised him to speak to reporters, acknowledged that sometimes there were so many people waiting, desperate for gas, that they couldnâ€™t fill all of their canisters completely.
â€œThere are times when we donâ€™t have enough oxygen to fill everybodyâ€™s tanks completely,â€ he said. â€œThere are times when we have to reduce the refill, so that everybody who is line can at least bring some oxygen home to their relatives.â€
To top off the problems, city officials have done little to combat price hikes that doubled or tripled the price of a refill, but they have shut down a black market in which producers of industrial-grade oxygen were selling canisters for medical use. Industrial oxygen, used to operate acetylene torches, is not as pure as the medical-grade gas.
The city government has started a program to give some people oxygen canisters or oxygen concentrators, which are machines that pull oxygen from the air and donâ€™t need to be refilled. But there arenâ€™t enough to go around, and buying one of the machines on the private market is prohibitively expensive for most families.
Before the pandemic, basic machines started around $900, but prices have since reported risen to $1,500 or more.
â€œThe prices for concentrators have gone through the roof, there has been too much profiteering,â€ MÃ©ndez Rojas said.
All primary schools in London are set to close for the start of the new term after the UK government bowed to protests and legal pressure from the capitalâ€™s local authorities amid fears of Covid-19 infection rates, Richard Adams and Simon Murphy report.
The U-turn comes after the government initially named 50 education authorities in the south of England, including many of those in and around London, where primary schools would be closed to most pupils for the first two weeks of term.
But the list omitted several London areas where Covid-19 transmission rates remain high including the borough of Haringey, whose leaders said they were prepared to defy the government and support any schools that decided to close to protect staff and pupils.
The protests from local authority leaders came to a head with a letter to the education secretary, Gavin Williamson, from nine London authorities, including Islington, Lambeth and the City of London, asking for their primary schools to be closed and suggesting they were prepared to take legal action.
The action provoked an emergency Cabinet Office meeting on New Yearâ€™s Day, which signed off on the revision, adding the remaining 10 London education authorities to the governmentâ€™s contingency areas.
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