Britain on Wednesday became the first country to authorize an easy-to-handle COVID-19 vaccine whose developers hope it will become the “vaccine for the world.” The approval and a shift in policy that will speed up rollout of the vaccine in the U.K. come as a surge in infections threatens to swamp British hospitals.
The Department of Health said it had accepted a recommendation from the Medicines and Healthcare Products Regulatory Agency to authorize emergency use of the vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca.
“The rollout will start on Jan. 4 and will really accelerate into the first few weeks of next year,” British Health Secretary Matt Hancock told told Sky News. Britain has bought 100 million doses of the vaccine.
AstraZeneca chief executive Pascal Soriot told BBC Radio 4 the company could start shipping the first doses of the vaccine Wednesday or Thursday “and the vaccination will start next week and we will get to 1 million — and beyond that — a week, very rapidly.”
Hundreds of thousands of people in the U.K. have already received a different vaccine, made by U.S. drugmaker Pfizer and German firm BioNTech.
Soriot said it was “an important day for millions of people in the U.K. who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit.”
Coronavirus vaccines have typically been given in two doses, with an initial shot followed by a booster about three weeks later.
But in a change of approach, the British government said that with the AstraZeneca vaccine it would prioritize giving as many people as possible a single dose, which is believed to give a large measure of protection against the virus. It said people at the highest risk would get priority, and everyone would get a second jab within 12 weeks of the first.
The new strategy comes against a backdrop of soaring infections in the U.K. The number of hospitalized COVID-19 patients has surpassed the first peak of the outbreak in the spring, with authorities blaming a new, more transmissible variant of the virus, first identified in southeast England, for the spike.
Oxford University’s Dr. Andrew Pollard, one of the leaders of the development team, offered hope the newly approved vaccine will help.
“At the moment, there’s no evidence that the vaccines won’t work against the new variant,” Pollard told Radio 4. “But that is something which we have to look at. We can’t be complacent about this variant or perhaps future variants.”
Partial results from studies in almost 24,000 people in Britain, Brazil and South Africa suggest the shots are safe and about 70% effective for preventing illness from coronavirus infection.
That’s not as good as some other vaccine candidates, but Soriot recently told the Sunday Times newspaper that he was confident the vaccine would prove as effective as its rivals.
The Oxford-AstraZeneca vaccine is expected to be relied on in many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage some other vaccines require. The company has said it will sell it for $2.50 a dose and plans to make up to 3 billion doses by the end of 2021.
“We have a vaccine for the world,” said Pollard.
Researchers claim the vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given a half dose because of a manufacturing error. However, the second group included only 2,741 people — too few to be conclusive.
Questions also remain about how well the vaccine protects older people. Only 12% of study participants were over 55 and they were enrolled later, so there hasn’t been enough time to see whether they develop infections at a lower rate than those not given the vaccine.
Researchers also were criticized for lack of information in September, when studies were suspended because a participant suffered a serious illness. AstraZeneca initially declined to provide further details due to patient confidentiality.
Ultimately, the trials resumed after regulators reviewed safety data and decided it was safe to continue. Published partial results show no hospitalizations or severe disease among those who received the vaccine. A separate study testing the AstraZeneca vaccine in the U.S. also is underway.
The vaccine will become the second COVID-19 vaccine in use in Britain. On Dec. 2, regulators gave emergency authorization to the Pfizer-BioNTech vaccine.
Having another vaccine available means that more people can get protection, said Sarah Gilbert, an Oxford scientist involved in the AstraZeneca project. It takes a different approach than the Pfizer-BioNTech one or another developed in the United States from Moderna Inc.
The ultra-cold storage those other vaccines need is “very impractical” in developing countries, said Dr. Gillies O’Bryan-Tear, chair of policy and communications for Britain’s Faculty of Pharmaceutical Medicine. It means the AstraZeneca one “may reach more parts of the world than the Pfizer one,” he said.
Britain’s action likely means the World Health Organization will soon clear the AstraZeneca vaccine for use in a global effort to help poor countries, called COVAX. The initiative, led by WHO and the vaccines alliance GAVI, has secured access to at least 100 million doses of the vaccine, with options and other deals to buy more. But none can be distributed until green-lighted by WHO.
The UN health agency does not licence or regulate vaccines itself, but typically evaluates vaccines once they have been approved by an agency such as the U.K. regulator or the European Medicines Agency. WHO experts conduct their own evaluation of whether or not the risks of a vaccine outweigh its benefits and then make a recommendation for the shots to be “pre-qualified” so they can be bought by donors for developing countries.
Most coronavirus vaccines to be used in poorer countries likely will be made by the Serum Institute of India, which has been contracted by AstraZeneca to make 1 billion doses. In June, the pharmaceutical company announced that the Serum Institute would produce 400 million doses by the end of 2020 but as of early December, only about 50 million doses had been manufactured after production was halted several times.
In addition to the Serum Institute, AstraZeneca also has deals with vaccine makers in Brazil, South Africa and China to make the Oxford-developed vaccine for use in developing countries.
Corder reported from The Hague, Netherlands. AP medical writer Maria Cheng in Toronto and AP correspondent Jill Lawless in London contributed reporting.
EU regulator endorses use of Moderna's COVID-19 shot for children – Al Jazeera English
European Medicines Agency gives all clear for vaccine to be used in children aged between 12 and 17.
The European Union’s medicines regulator has recommended authorising Moderna’s COVID-19 vaccine for use in children aged between 12 and 17, marking the first time the shot has been approved for people under 18.
In a decision on Friday, the European Medicines Agency (EMA) said research in more than 3,700 children of 12 to 17 years of age showed that the shot produced a comparable antibody response to that seen in 18- to 25-year-olds.
Use of the vaccine, Spikevax, will be the same in adolescents as in people over 18, the EMA said.
Formal approval by the European Commission – the EU’s executive arm – is needed to start rolling out the vaccine for teenagers. The body typically follows EMA recommendations.
Until now, the vaccine made by Pfizer and its German partner BioNTech has been the only option for use in children as young as 12 in North America and the EU.
Vaccinating children has been considered important for reaching herd immunity and in light of the rapid spread of the highly contagious Delta variant.
Most children with COVID-19 develop only mild symptoms or none. Yet children remain at risk of becoming seriously ill and can spread the virus.
‘Benefits outweigh the risks’
Moderna said in May that its vaccine was found to be safe and effective in teenagers. Hundreds of millions of doses of the shot have already have been administered to adults.
The EMA said common side effects in teenagers after vaccination with Spikevax were similar to those seen in older people.
But due to a smaller study size, the trial could not detect new uncommon side effects or estimate the risk of known ones such as myocarditis and pericarditis.
“The overall safety profile of Spikevax determined in adults was confirmed in the adolescent study; the CHMP (Committee for Medicinal Products for Human Use) therefore considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks,” the EMA said.
Heart inflammation such as myocarditis and pericarditis has been listed by the EMA as a possible but rare side effect from use of mRNA vaccines such as Moderna’s and Pfizer’s in adults.
Spikevax is already being used in the EU for people over 18, and in the United States and Canada.
Moderna has also sought authorisation in the US and Canada for its use in adolescents.
But with global vaccine supplies still tight, much of the world still is struggling to immunise adults, let alone children.
Agencies including the World Health Organization have urged rich countries to donate their doses to the developing world – where fewer than 2 percent of people have been vaccinated – rather than moving on to inoculate their less vulnerable populations.
Ontario reports 170 new COVID-19 cases, over 8.4 million fully vaccinated – CTV Toronto
Ontario is reporting a slight decrease in new COVID-19 cases on Saturday from the previous day.
Officials marked 170 new cases of COVID-19 Saturday, with three additional deaths.
The province reported 192 new cases on Friday and 185 on Thursday.
The seven-day rolling average now stands at 159, compared to 151 a week ago.
Provincial labs processed more than 19,131 test specimens, generating a positivity rate of at least 0.8 per cent, according to the Ministry of Health.
The province’s COVID-19-related death toll stands at 9,311.
Another 150 people recovered from the disease yesterday, resulting in 1,424 active cases across the province.
Right now, there are 125 people in hospital with COVID-19 and 132 patients being treated in intensive care, according to the Ministry of Health.
The hospitalization data presented by the province has been skewed over the past several weeks, which may be explained by a delay in patient reporting.
Where are the new cases?
Officials are reporting 44 new cases in Toronto, 26 in Peel Region, 17 in Hamilton, 15 in the Region of Waterloo and 13 in Grey Bruce.
Update on COVID-19 variants of concern
The Ministry of Health is reporting 107 new cases of the Alpha variant Saturday, bringing the total number of cases in the province to 145,255.
Officials reported 12 new cases of Delta variant, B.1.617.2 and the case total is now 3,897.
Four cases of the Beta variant, B.1.351 were also recorded. So far, there have been a total of 1,489 cases of the Beta variant reported in Ontario.
As for the Gamma variant, P.1, 10 new cases were recorded today. The total number of Gamma variants recorded in Ontario is now 5,140.
The province said it administered 124,261 doses of COVID-19 vaccines Friday.
Throughout Ontario’s seven-month vaccination campaign, over 18.8 million needles have gone into arms.
As of Saturday, 8,480,761 people have received both doses and are considered to be fully vaccinated.
The numbers used in this story are found in the Ontario Ministry of Health’s COVID-19 Daily Epidemiologic Summary. The number of cases for any city or region may differ slightly from what is reported by the province, because local units report figures at different times.
New Brunswick to move to Green phase on July 30; reports three new COVID-19 cases Friday – CTV News Atlantic
New Brunswick will move into the Green phase of its recovery plan on July 30, lifting all public health restrictions and opening the province to travel, Premier Blaine Higgs announced Friday.
“This morning, Cabinet and the all-party cabinet committee on COVID-19 agreed that New Brunswick’s mandatory order will not be renewed on July 30. This will lift all mandatory travel and public health restrictions that have been in place since the pandemic began,” said Higgs during Friday’s news update.
As of 11:59 p.m. on July 30, the following restrictions will be removed in the province.
- Lift all mandatory travel and public health restrictions that have been in place over the course of the pandemic.
- Lift all provincial border restrictions; provincial border checks will cease, and registration will no longer be required to enter New Brunswick from anywhere in Canada.
- Lift all limits on gatherings and the number of people within facilities. Capacity limits in theatres, restaurants and stores will no longer be required.
- End the requirement to wear face masks in public.
“We came to this decision because we have reached our goal of 75 per cent of our eligible population having received their first vaccine, and are now at 81 per cent,” said Higgs on Friday. “We know that there will be new cases, but thanks to the amount of people that are already vaccinated, we do not think that our health care system will be threatened.”
As of midnight on July 30, all provincial border restrictions will be lifted, provincial border checks will cease, and registration will no longer be required to visit New Brunswick from anywhere in Canada.
However, travellers will still be subject to Canada’s federal restrictions on International travel.
“We will be living with COVID-19, so we encourage New Brunswickers to continue to practise protective health measures such as hand-washing, coughing in your elbow, staying home when sick and wearing a mask if you so choose,” said Dr. Jennifer Russell, chief medical officer of health. “This virus is still with us and we should all expect to see cases as normal travel returns. If you have symptoms, get tested.”
During Friday’s news update, Higgs and Russell emphasized that some facilities and businesses may choose to maintain their own policies on protective health measures, even after restrictions are lifted.
“When we move to Green, not everyone will feel ready to jump back into life as if nothing happened. We all will have to adapt to this new environment in our own way,” said Higgs. “For some, the return to normal will be at a fast pace. Others may want to ease out of the safety measures we have been surrounded by for so long. There is no right way to do this. Everyone must do what feels best for them while remaining safe.”
THREE NEW CASES ANNOUNCED FRIDAY
New Brunswick is reporting three new cases of COVID-19 on Friday, along with one recovery, as the active number of cases in the province rises to 10.
Two of the new cases were identified in the Saint John region (Zone 2), involving two people ages 19 and under, are both related to travel.
One new case was identified in the Fredericton region (Zone 3), involving an individual in their 20s, and remains under investigation.
New Brunswick has had 2,350 cumulative cases of COVID-19 since the start of the pandemic.
In total, 2,293 people have recovered, and 46 people have died in the province from COVID-19.
There is currently no one hospitalized in New Brunswick due to COVID-19.
“We are approaching having one-million COVID-19 vaccines in the province, a very important milestone in our fight against the virus for our province and the country,” said Russell. “While we are well on our way to getting as many New Brunswick’s vaccinated as we can, we must remember that the COVID-19 virus still exists and can still spread. While case numbers have been low, we are still encouraging anyone having symptoms to make an appointment to get tested.”
On Thursday, 727 tests were conducted in the province. A total of 376,470 tests have been conducted since the beginning of the pandemic.
The number of cases is broken down by New Brunswick’s seven health zones:
- Zone 1 – Moncton region: 490 confirmed cases (six active cases)
- Zone 2 – Saint John region: 300 confirmed cases (two active cases)
- Zone 3 – Fredericton region: 449 confirmed cases (two active cases)
- Zone 4 – Edmundston region: 754 confirmed cases (no active cases)
- Zone 5 – Campbellton region: 185 confirmed cases (no active cases)
- Zone 6 – Bathurst region: 133 confirmed cases (no active cases)
- Zone 7 – Miramichi region: 39 confirmed cases (no active cases)
THOUSANDS OF VACCINE APPOINTMENTS AVAILABLE
In a release issued Tuesday, New Brunswick health officials say there are thousands of first and second dose Pfizer and Moderna appointments available at regional health authority clinics and participating pharmacies.
Vaccination clinics are taking place every day this week with appointments available in each region. New Brunswickers who have yet to be immunized with two doses of vaccine are encouraged to book an appointment through a participating pharmacy or at a Vitalité or Horizon health network clinic.
New Brunswick’s COVID-19 online dashboard provides an update on the amount of vaccines that have been administered to date.
As of Friday, 997,798 doses of COVID-19 vaccine have been administered in New Brunswick. The province says 81.2 per cent of the eligible population has received at least one dose, with 62.7 per cent now fully vaccinated.
All eligible New Brunswickers can book their second dose appointments if at least 28 days have passed since their first dose.
To receive their second dose, New Brunswickers are asked to bring a signed consent form, their Medicare card and a copy of the record of immunization provided after receiving their first dose.
Appointments for people who have not yet received their first dose continue to be available to all New Brunswickers aged 12 and older at regional health authority clinics and through participating pharmacies.
Public Health is also reminding New Brunswickers to keep a copy of their Record of Immunization form as their official proof of vaccination.
YELLOW LEVEL REMINDER
All of New Brunswick remains under the Yellow level of recovery under the province’s order, which will be lifted effective 11:59 p.m. July 30.
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