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WHO clears Pfizer coronavirus vaccine for emergency use – PBS NewsHour

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GENEVA — The World Health Organization says it has cleared the Pfizer-BioNTech coronavirus vaccine for emergency use, meaning poorer countries may soon get access to the shot already available in Europe and North America.

Every country that has a drug regulatory agency will have to issue its own approval for any COVID-19 vaccine, but countries with weak systems usually rely on WHO to vet the shots.

The global body said late Thursday that the decision to issue its first emergency use validation for a COVID-19 vaccine “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.”

WATCH: Why it could be years before Africans have access to coronavirus vaccines

The U.N. health agency said its review found the Pfizer-BioNTech vaccine, which has already received clearance in the United States, Britain, the European Union and a dozen other countries, “met the must-have criteria for safety and efficacy set out by WHO.”

The BioNTech-Pfizer vaccine has to be stored at ultra-frozen temperatures, a big hurdle for developing countries where the required freezers and reliable electricity supply may not be available.

“This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible,” WHO said, adding that it was “working to support countries in assessing their delivery plans and preparing for use where possible.”

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In coronavirus vaccine drive, Deep South falls behind – Airdrie Today

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ATLANTA — The coronavirus vaccines have been rolled out unevenly across the U.S., but four states in the Deep South have had particularly dismal inoculation rates that have alarmed health experts and frustrated residents.

In Alabama, Georgia, Mississippi and South Carolina, less than 2% of the population had received its first dose of a vaccine at the start of the week, according to data from the states and the U.S. Centers for Disease Control and Prevention.

As in other parts of the country, states in the South face a number of challenges: limited vaccine supplies, health care workers who refuse to get inoculated and bureaucratic systems that are not equipped to schedule the huge number of appointments being sought.

But other states have still managed — at their best — to get the vaccines into the arms of more than 5% of their populations.

Though it’s not clear why the Deep South is falling behind, public health researchers note that it has typically lagged in funding public health and addressing disparities in care for its big rural population.

“When you combine a large percentage of rural residents who tend to be the hard-to-reach populations and have lower numbers of providers with trying to build a vaccine infrastructure on the fly, that’s just a recipe for a not-so-great response,” said Sarah McCool, a professor in public health at Georgia State University.

In Georgia, the state’s rural health system has been decimated in recent years, with nine hospital closures since 2008, including two last year. Local health departments have become the primary vaccine providers in some locations, as officials work to add sites where doses can be administered.

“If we’re the only game in town, this process is going to take a long time,” Lawton Davis, director of a large public health district that includes Savannah, said at a news conference on Monday.

Alabama and Mississippi have also been hit hard by rural hospital closures. Seven hospitals have shut down in Alabama since 2009 and six in Mississippi since 2005, according to researchers at the University of North Carolina’s Sheps Center. Alabama, Georgia and Mississippi ranked in the bottom five of U.S. states in their access to health care, according to a 2020 report from a not-for-profit foundation connected to insurance giant UnitedHealth.

But overall, experts say it’s too early in the vaccine rollout to draw conclusions about the region’s shortcomings, and they can’t easily be attributed to a particular factor or trend.

“We’re sort of building this plane as we’re flying, and there are going to be missteps along the way,” said Amber Schmidtke, a microbiologist who has been following vaccine dissemination in the South.

Officials in the individual states have cited a number of challenges, but also acknowledged shortcomings.

“We have too many vaccines distributed that are not in arms yet,” said Mississippi Gov. Tate Reeves, who noted that some hospitals in the state are not using their vaccine doses. He said that practice “has to stop.”

Georgia Gov. Brian Kemp cited a similar challenge and warned providers holding on to vaccines that the state would take their unused doses even if that required “firing up” his pickup truck and doing it himself.

But in South Carolina, hospital officials say it is the state that has moved too slowly to expand access to the vaccinations, leaving them with unused doses. The state recently did offer the vaccine to those 70 and older.

Mississippi’s Reeves said one of the biggest weaknesses in the state’s vaccination system is the federal partnership with CVS and Walgreens to administer vaccinations in long-term care facilities. The pharmacy chains have been slow in hiring enough people to do the work in Mississippi, the governor said.

CVS Health said in a statement that it has “the appropriate resources to finish the job” at long-term care facilities. Walgreens did not respond to an email.

During an online forum hosted by Jackson State University in Mississippi on Thursday, U.S. Surgeon General Jerome Adams, who is Black, noted the reluctance of many African Americans to be vaccinated. He cited a general mistrust of medical systems stemming back to a now-defunct government study that started in the 1930s and left Black men untreated for syphilis for decades.

So far, only 15% of COVID-19 vaccinations in Mississippi have gone to Black people, who make up about 38% of the population, state health officer Dr. Thomas Dobbs said during the forum.

Officials in all four states also said some health care workers — among the first groups eligible for a vaccine — are choosing not to get inoculated. And some stressed that states were dealing with limited supplies and high demand and implored people to be patient.

“Yes, the phone lines will be busy. Yes, the websites will certainly crash,” Kemp said Tuesday. “There are simply vastly more Georgians that want the vaccine than can get it today.”

Mississippi officials said the state’s website and telephone hotline were overwhelmed after the governor announced Tuesday that vaccinations were available to people 65 or older or people who have underlying medical conditions.

Liz Cleveland, a 67-year-old retired state employee who lives in Jackson, waited hours on the website using her cellphone, computer and tablet only to encounter unknown errors.

“It’s like gambling. You may hit or you may bust,” Cleveland said.

About 2 a.m. Wednesday, she was finally able to book appointments for herself and her husband next week in Hattiesburg, which is 90 miles (145 kilometres) away. Mississippi officials said Thursday that they will open an additional drive-thru site for vaccinations soon in the state’s largest county.

Alabama officials also have been inundated with requests for appointments since announcing the state will begin vaccinations for people over 75 next week. A state hotline received more than a million calls the first day it was open.

Celia O’Kelley of Tuscaloosa said she couldn’t get through to anyone to get an appointment for her 95-year-old mother.

“I am scared because Tuscaloosa is a hot spot,” she said.

___

Associated Press writers Kim Chandler in Montgomery, Alabama; Emily Wagster Pettus in Jackson, Mississippi; and Michelle Liu in Columbia, South Carolina, contributed to this report.

Sudhin Thanawala, The Associated Press






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Norway Warns of Vaccination Risks for Sick Patients Over 80 – Bloomberg

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Norway said Covid-19 vaccines may be too risky for the very old and terminally ill, the most cautious statement yet from a European health authority as countries assess the real-world side effects of the first shots to gain approval.

Norwegian officials said 23 people had died in the country a short time after receiving their first dose of the vaccine. Of those deaths, 13 have so far been autopsied, with the results suggesting that common side effects may have contributed to severe reactions in frail, elderly people, according to the Norwegian Medicines Agency.

“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences,” the Norwegian Institute of Public Health said. “For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”

The recommendation does not mean younger, healthier people should avoid being vaccinated. But it’s an early indication of what to watch as countries begin to issue safety monitoring reports on the vaccines. Emer Cooke, the new head of the European Medicines Agency, has said tracking the safety of Covid vaccines, especially those relying on novel technologies such as messenger RNA, would be one of the biggest challenges once shots are rolled out widely.

Allergic reactions have been uncommon so far. In the U.S., authorities reported 21 cases of severe allergic reactions from Dec. 14-23 after administration of about 1.9 million initial doses of the vaccine developed by Pfizer Inc. and BioNTech SE. That’s an incidence of 11.1 cases per million doses, according to the Centers for Disease Control and Prevention.

Though both Covid-19 vaccines approved so far in Europe were tested in tens of thousands of people — including volunteers in their late 80s and 90s — the average trial participant was in his or her early 50s. The first people to be immunized in many places have been older than that as countries rush to inoculate nursing-home residents at high risk from the virus.

Norway has given at least one dose to about 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly.

In France, one frail patient died in a care home two hours after being vaccinated, but authorities said given the patient’s previous medical history there is no indication the death was linked to the vaccine. The French pharmaceutical safety agency on Thursday reported four cases of severe allergic reactions and two incidents of irregular heartbeat after vaccination.

Representatives for Pfizer and BioNTech didn’t immediately respond to requests for comment.

The Pfizer-BioNTech vaccine approved late last year has been used most broadly, with a similar shot from Moderna Inc. approved earlier this month also now being administered.

— With assistance by Rudy Ruitenberg, and Stephen Treloar

(Updates with context from the fourth paragraph)

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    Quebec to allow 90-day delay before second vaccine doses, more than double what national panel advises – CTV Montreal

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    QUEBEC CITY —
    Quebec public health officials said Thursday that provincial advisors have recommended a prolonged COVID-19 vaccination schedule of up to 90 days between the first and second dose — more than double what a national advisory committee recommended a day earlier.

    “In our context, that is the best strategy,” said Health Minister Christian Dubé at a Thursday press conference on Quebec’s vaccination progress.

    Quebec announced in late December it would be delaying second doses or “booster shots” of the vaccine, but the province hasn’t said until Thursday what kind of delay it had in mind.

    Provincial officials now say the second dose should come between 42 and 90 days after the first.

    Such a schedule would allow the province to give the vaccine to more people who would otherwise have to wait for their first dose, said the health officials.

    A delay of 90 days is much longer than what’s been recommended by Pfizer (21 days, for its vaccine), Moderna (28 days, for its vaccine), and federal public health advisors in their recommendation on Wednesday (up to 42 days for both vaccines).

    However, that national advisory panel, called NACI, said Thursday that provinces have some leeway to make their own decisions and they aren’t opposing Quebec’s 90-day timeline.

    Canada’s Deputy Chief Public Health Officer, Dr. Howard Njoo, said that certain provinces’ “exceptional circumstances” may mean they need to depart from federal recommendations.

    “It is sort of the interplay between the actual epidemiology, on the ground, the fact that there is a obviously increased rate of cases, hospitalizations,” said Njoo, and the vaccine guidelines.

    EXTENSION BASED ON ‘EXPERIENCE,’ NOT DATA, SAYS QUEBEC

    So why is the province talking about 90 days?

    Health Ministry advisor Dr. Richard Massé said Quebec experts believe it’s likely that immunity will last longer than 42 days, as recommended by the NACI panel, but clinical trials have not extended past that.

    What they’re relying on instead is past experience with other vaccines.

    “What we have is the experience working with many vaccines,” said Massé. “Immunity is not something that is ‘on’ or ‘off.’”

    While Quebec’s Ministry of Health has said that a single dose can provide up to about 90 per cent efficacy against the virus, Pfizer says that one dose alone is just 52.4 per cent effective.

    Massé told reporters the discrepancy comes from different and more specific analysis of Pfizer’s trial data.

    He said that Pfizer, when studying the issue, had been including people who had gotten their first dose but hadn’t had time to build up immunity.

    “It takes 12 to 14 days to have immunity,” said Massé. “If you count people who get the disease two, three, five days after getting the vaccine, it’s not really a failure of vaccination because immunity [hasn’t been built up].”

    One expert told CTV News this week that there are big variations in the efficacy estimates because of the small sample size of people who got only the first shot in the Pfizer trial. That expert, Dr. Donald Vinh, said that in his opinion the efficacy is likely somewhere in the range of 60 to 69 per cent.

    In a statement to CTV News, Pfizer Canada spokeperson Christina Antoniou reiterated earlier statements that Pfizer has not evaluated the efficacy of its vaccine on alternative dosing schedules.

    “There are no data to demonstrate that protection after the first dose is sustained after 21 days,” she said.

    “We recognize that recommendations on alternative dosing intervals reside with health authorities and may include adapting public health recommendations in reaction to evolving circumstances during a pandemic,” she wrote.

    But for Pfizer, “as a biopharmaceutical company working in a highly regulated industry, our position is supported by the label and indication agreed upon with Health Canada and informed by data from our Phase 3 study.”

    Minister Dubé said the province has been talking to Pfizer. On Jan. 5, Pfizer told CTV News that Quebec had not informed the company before deciding to delay the second dose.

    “We’ve had conversations with Pfizer,” said Dube, “to inform them as to why we were making those decisions.”

    Earlier this week, Premier François Legault said that in discussions with the federal government, the province learned there may be a risk of losing Quebec’s vaccine supply if Pfizer isn’t happy with its dosing regime.

    On Thursday, Pfizer’s statement said the company “remain[s] committed to our ongoing dialogue with regulators, health authorities and governments, and to our continued data-sharing efforts to help inform any public health decisions aimed at defeating this devastating pandemic.”

    Both Massé and Dubé said they are hoping for an increased supply, since they would favour a shorter delay before the second dose if the province’s deliveries of vaccine increase.

    “Saving lives is a moral imperative,” said Dubé.

    “The more doses we have, the more we’re going to be able to decrease the time between the first and second dose.”

    NEXT STEPS FOR QUEBEC’S VACCINATION

    With about 65 per cent of CHSLD residents already given a first dose, Dubé said Quebec will begin vaccinating residents of private seniors’ homes (RPAs) on Jan. 25.

    He said that with a prolonged schedule between the first and second doses, the province can also consider vaccinating the general senior population sooner.

    With new vaccine shipments arriving in the province this week, Dubé said 115,000 people have now been vaccinated.

    In total, the province has received 162,000 doses so far. Dubé says Quebec is on track to increase that total to 250,000 in February.

    –With files from CTV’s Kelly Greig

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