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FDA panel rejects plan to offer Pfizer booster shots against COVID-19 to most Americans – WAGM

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WASHINGTON (AP) — Dealing the White House a stinging setback, a government advisory panel overwhelmingly rejected a plan Friday to give Pfizer COVID-19 booster shots across the board, and instead endorsed the extra vaccine dose only for those who are 65 or older or run a high risk of severe disease.

The twin votes represented a heavy blow to the Biden administration’s sweeping effort, announced a month ago, to shore up nearly all Americans’ protection amid the spread of the highly contagious delta variant.

The nonbinding recommendation — from an influential committee of outside experts who advise the Food and Drug Administration — is not the last word. The FDA will consider the group’s advice and make its own decision, probably within days. And the Centers for Disease Control and Prevention is set to weigh in next week.

In a surprising turn, the advisory panel rejected, 16-2, boosters for almost everyone. Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.

Then, in an 18-0 vote, it endorsed extra shots for people 65 and older and those at risk of serious disease. Panel members also agreed that health workers and others who run a high risk of being exposed to the virus on the job should get boosters, too.

That would help salvage part of the White House’s campaign but would still be a huge step back from the far-reaching proposal to offer third shots of both the Pfizer and Moderna vaccines to Americans eight months after they get their second dose.

The White House sought to frame the action as progress.

“Today was an important step forward in providing better protection to Americans from COVID-19,” said White House spokesman Kevin Munoz. “We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week.”

The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

The FDA and CDC will most likely decide at some later point whether people who received the Moderna or Johnson & Johnson shots should get boosters.

During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to almost everybody 16 and over.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

Dr. Amanda Cohn of the CDC said, “At this moment it is clear that the unvaccinated are driving transmission in the United States.”

In a statement, Kathrin U. Jansen, Pfizer head of vaccine research and development, said the company continues to believe that boosters will be a “critical tool in the ongoing effort to control the spread of this virus.”

Scientists inside and outside the government have been divided recently over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the delta variant.

The unexpected turn of events could reinforce criticism that the Biden administration got out ahead of the science in its push for boosters. President Joe Biden promised early on that his administration would “follow the science,” in the wake of disclosures of political meddling in the Trump administration’s coronavirus response.

The FDA panel’s overwhelming initial rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.

Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.

Representatives for Pfizer argued that it is important to start shoring up immunity before protection begins to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.

Both Pfizer and the Israeli representatives faced pushback from panelists. Several were skeptical about the relevance of Israel’s experience to the U.S. Another concern was whether third doses would exacerbate serious side effects, including rare instances of heart inflammation in younger men.

Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to those already reported.

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said he was supportive of a third dose for adults over 60 or 65, but “I really have trouble” supporting it for anyone down to age 16.

While an extra shot would probably at least temporarily reduce cases with mild or no symptoms, “the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Offit said.

Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots in mid-August, setting the week of Sept. 20 as an all-but-certain start date. But that was before FDA staff scientists had completed their own assessments of the data.

Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said studies show the shots are working well.

On Friday, U.S. Surgeon General Dr. Vivek Murthy said the Biden administration announcement was not aimed at pressuring regulators to act but was instead an attempt to be transparent with the public and be prepared in the event that boosters won approval.

“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” Murthy said.

The Biden plan has also raised major ethical concerns about impoverished parts of the world still clamoring for vaccine. But the administration argued that the plan was not an us-or-them choice, noting that the U.S. is supplying large quantities of vaccine to the rest of the globe.

The U.S. has already approved Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.

Some Americans, healthy or not, have managed to get boosters, in some cases simply by showing up and asking for a shot. And some health systems already are offering extra doses to high-risk people.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright 2021 The Associated Press. All rights reserved.

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Week five without LRT service and Canada's women's soccer team plays in Ottawa: Five stories to watch this week – CTV Edmonton

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OTTAWA —
A fifth week begins without LRT service, Ottawa’s top doctor has ‘cautious optimism’ for fall during the COVID-19 pandemic, and Canada’s Olympic champion women’s soccer team takes the pitch at TD Place.

CTVNewsOttawa.ca looks at five stories to watch in Ottawa this week

ALL ABOARD? CITY REVIEWS RETURN TO SERVICE PLAN FOR LRT

Ottawa transit riders could find out this week when service will resume on the Confederation Line.

City staff spent the weekend reviewing the return-to-service plan submitted by Rideau Transit Group following the LRT car derailment near Tremblay Station on Sept. 19.

Sources tell CTV News Ottawa the RTM return to service plan has a specific date, but staff must review the entire plan to assess if it’s possible. Officials expect that when the trains resume, it will be a gradual return to service.

City Manager Steve Kanellakos told council last week that Rideau Transit Group has identified a loose gearbox as the issue that caused the derailment.

The Transit Commission is scheduled to receive an update on the Confederation Line on Wednesday, which could include details on the derailment and return to service plan.

Meantime, the new boss of OC Transpo arrives on Monday.

Renee Amilcar replaces John Manconi as Transportation Services General Manager after Manconi retired last month. Amilcar worked with Montreal’s transit system as the director of bus maintenance.

QR CODES FOR COVID-19 VACCINE PASSPORT

Ontario’s new COVID-19 vaccine verification app and QR code system will roll out this week for people to access non-essential restaurants and services.

Individuals can download their QR codes through the Ontario government’s website, while businesses can download an app to check a vaccination status.

When a proof of vaccination QR code is scanned in the app, it will respond with either a green check, yellow caution sign or a red “X,” which means the certificate is invalid.

The yellow caution sign could be issued because the vaccine certificate being scanned was issued outside of Canada, the app says.

You will still need to show a piece of ID with the QR code.

Verify Ontario app

‘CAUTIOUS OPTIMSIM’ ON COVID-19 SITUATION IN OTTAWA

With Ottawa approaching a first dose vaccination rate of 90 per cent, medical officer of health Dr. Vera Etches says her outlook for fall is “one of cautious optimism.”

However, Dr. Etches is concerned about the number of close contacts unvaccinated children under 12 currently have.

“The most common source of COVID-19 infections for children and youth are household members.”

Etches is asking parents to limit extra curricular activities, sleepovers and other social activities outside of school for unvaccinated school to limit cases and help keep schools open.

Currently 89 per cent of Ottawa residents 12 and older have received one dose of a COVID-19 vaccine, while 85 per cent of residents are fully vaccinated. Dr. Etches has set a goal of over 90 per cent of residents fully vaccinated to limit the spread of the virus.

As of Sunday, there are five outbreaks in Ottawa elementary schools. The number of active cases is at 258, and hospitalizations remain low.

COVID-19 vaccine in Ottawa

MORE MONEY FOR THE OTTAWA PUBLIC LIBRARY

Ottawa’s finance and economic development committee and the Ottawa Public Library Board will vote Tuesday on spending more money to build the new super-library at LeBreton Flats.

The price-tag for the new joint library between the Ottawa Public Library and Library and Archives Canada jumped by $131 million, plus another $10 million for the parking garage.

A report says the increase from the initial estimate of $193 million (including the parking garage) to $334 million can be directly attributed to an escalation in the construction market.

“Canada is experiencing a significant increase in construction costs due to COVID-19 impacts,” said staff. “A combination of material shortages and commodity escalation, supply chain slowdowns and pressures, labour implications and a superheated construction market, have all been described by the Ottawa Construction Association and observed in recent city tenders.”

The city of Ottawa must spend an extra $65 million for the new super library, which will be covered through borrowing, using surplus funds and development charges.

Ottawa Public Library

CANADA’S WOMEN’S SOCCER TEAM PLAYS IN OTTAWA

Canada’s Olympic champion women’s soccer team will play in Ottawa next weekend, the first match since winning a historic Gold medal at the Summer Games in Tokyo.

Canada faces New Zealand at TD Place as part of the Women’s National Team Celebration Tour.  Game time 3 p.m. Saturday.

The team includes Ottawa’s Vanessa Gilles, who scored the decisive penalty shootout goal for Canada in the quarterfinals against Brazil.

For tickets, visit canadasoccer.com

canada women's soccer

EVENTS HAPPENING IN OTTAWA THIS WEEK

Tuesday

Ottawa Finance and Economic Development Committee meeting – 9 a.m.

Standing Committee on Environmental Protection, Water and Waste Management meeting – 1 p.m.

Ottawa Public Library Board meeting – 5 p.m.

Wednesday

Ottawa Transit Commission meeting – 9:30 a.m.

Atletico Ottawa vs. Valour FC. 7 p.m. at TD Place (TSN 1200)

Thursday

Ottawa Community and Protective Services Committee meeting – 9:30 a.m.

Ottawa Senators vs. San Jose Sharks. 7 p.m. at Canadian Tire Centre (TSN 1200 and TSN 5)

Saturday

Ottawa Senators vs New York Rangers. 1 p.m. at Canadian Tire Centre (TSN 5 and TSN 1200)

Canada’s women’s soccer team vs. New Zealand. 3 p.m. at TD Place

Ottawa Redblacks at Hamilton. 4 p.m. (TSN 1200 and TSN)

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Three more COVID-19 related deaths, 58 new cases, in New Brunswick Sunday – CTV News Atlantic

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New Brunswick is reporting three more COVID-19 related deaths on Sunday, bringing the total number in the province to 90. 

All three deaths occurred in Zone 5 (Campbellton region). Two people were aged 40-49 and one person was aged 80-89.

“My thoughts are with the loved ones of the people who have passed away today,”Premier Blaine Higgs said in a release.

“We all have a role to play in slowing the spread of the virus. I want to thank the businesses that have taken steps to motivate employees to get vaccinated and I encourage other businesses to do the same. COVID-19 can pose a serious risk in the workplace and may impact a business’s operations, especially if an unvaccinated employee contracts the disease.”

There are 57 people hospitalized due to the virus, with 18 in an intensive care unit.

“Of the 18 in an intensive care unit, none are fully vaccinated (16 are unvaccinated and two are partially vaccinated). Of the total of all hospitalized, 29 are unvaccinated, six are partially vaccinated and 22 are fully vaccinated,” says the release.

58 NEW CASES

Public health is also reporting 58 new cases of COVID-19 Sunday and 117 recoveries, dropping the number of active cases to 935.

Of the new cases, 35 – or 60 per cent – are unvaccinated, five – or nine per cent – are partially vaccinated, and 20 – or 34 per cent – are fully vaccinated.

RAPID-TESTING PROGRAM EXPANDS

Beginning Monday, Oct. 18, people who are not a positive COVID-19 case will be able to pick up free rapid-test kits which they can administer at home.

Public Health has doubled the number of rapid test kits for each pick-up location Monday and throughout this week to help meet the initial high demand.

All the pick-up centres will be open during their scheduled hours or until the daily supply has been given out.

“We’re grateful for the high interest in these tests as people clearly want to do what they can to help fight the COVID-19 virus,” Dr. Jennifer Russell, chief medical officer of health, said in a release.

“Thank you for your patience with staff at the centres as they work as quickly as possible to distribute the tests.”

The kits will be available to the public at large at the following locations provincewide:

  • Moncton: Greater Moncton Health Centre, 150 Edmonton Ave., (3 p.m. to 9 p.m. Monday to Thursday, 1 p.m. to 5 p.m. Friday, and 9 a.m. to noon Saturday)
  • Cocagne: Cocagne Health Clinic, 4813 Rte. 134, (8 a.m. to 10 a.m. and 2 p.m. to 4 p.m. Monday to Thursday, and 8 a.m. to noon Friday)
  • Moncton: 380 MacNaughton Ave. (10 a.m. to 6 p.m. Monday to Friday)
  • Edmundston: Edmundston Regional Hospital, 275 Hébert Blvd., (2 p.m. to 4 p.m. Monday to Friday)
  • Clair: Haut-Madawaska Medical Clinic, 809 Principale St., (1 p.m. to 3:30 p.m. Tuesday, Wednesday and Thursday)
  • Grand Falls: Grand Falls General Hospital, 625 Everard H. Daigle Blvd., (8 a.m. to 4 p.m. Monday to Friday)
  • Saint-Quentin: Hôtel-Dieu Saint-Joseph de Saint-Quentin, 21 Canada St., (2 p.m. to 5 p.m. daily)
  • Campbellton: E.L. Murray Medical Clinic, 3 Stanley St., (2 p.m. to 4 p.m. Monday to Friday)
  • Dalhousie: St. Joseph Community Health Centre, 280 Victoria St., (noon to 3 p.m. Monday to Friday)
  • Shediac: Shediac Regional Medical Centre, 419 Main St., (8:30 a.m. to 4:30 p.m. Monday to Friday)
  • Belledune: Jacquet River Health Centre, 41 Mack St., (1 p.m. to 3:30 p.m. Monday to Friday)
  • Bathurst: Chaleur Regional Hospital, 1750 Sunset Blvd., (12:30 p.m. to 1:30 p.m. Monday to Saturday)
  • Caraquet: Enfant-Jésus RHSJ Hospital, 1 Saint-Pierre Blvd. W., (1 p.m. to 4 p.m. Monday to Friday)
  • Tracadie: Tracadie Hospital, 400 Des Hospitalières St., (1 p.m. to 3 p.m. daily)
  • Lamèque: Lamèque Hospital and Community Health Centre, 29 De l’Hôpital St., (noon to 3 p.m. Monday to Friday)
  • Paquetville: Paquetville Health Centre, 1096 Du Parc St., (8 a.m. to 4 p.m. Monday, Tuesday, Thursday and Friday, 1 p.m. to 4 p.m. Wednesday)
  • Saint-Isidore: Saint-Isidore Community Health Centre, 3973-1 Des Fondateurs Blvd., (12:30 p.m. to 3 p.m. Monday to Friday)
  • Saint John: Diamond Jubilee Cruise Terminal, (10 a.m. to 6 p.m. Monday to Friday)
  • Fredericton: Exhibition Grounds, 361 Smythe St., (10 a.m. to 6 p.m. Monday to Friday)
  • Miramichi: 365 Wellington St. (10 a.m. to 6 p.m. Monday to Friday)

The rapid test screening program is aimed at people two and older who are not a confirmed positive COVID-19 case. A kit has five tests to be used over a 10-day period. People 16 and under must be accompanied by an adult to acquire a testing kit.

VACCINATION UPDATE

Public Health reported today that 82.4 per cent of eligible New Brunswickers are fully vaccinated against COVID-19 and 91.5 per cent have received their first dose of a vaccine.

All eligible New Brunswickers can book their second-dose appointments for a date that is at least 28 days after their first dose.

Those attending a vaccination clinic are asked to bring their Medicare card, a signed consent form and, for those receiving their second dose, a copy of the record of immunization provided after receiving their first dose.

REGIONAL BREAKDOWN OF NEW CASES

The 15 new cases in Zone 1 (Moncton region) are as follows:

  • four people 19 and under;
  • four people 20-29;
  • two people 30-39;
  • two people 40-49;
  • one person 60-69;
  • one person 70-79; and
  • one person 80-89.

Thirteen cases are under investigation and two cases are contacts of previously confirmed cases.

The three new cases in Zone 2 (Saint John region) are as follows:

  • a person 20-29; and
  • two people 50-59.

All three cases are under investigation.

The ten new cases in Zone 3 (Fredericton region) are as follows:

  • one person 19 and under;
  • a person 20-29;
  • two people 30-39;
  • a person 40-49;
  • a person 50-59; and
  • four people 60-69.

All ten cases are under investigation.

The 13 new cases in Zone 4 (Edmundston region) are as follows:

  • five people 19 and under;
  • three people 20-29
  • a person 30-39;
  • a person 40-49;
  • a person 60-69; and
  • two people 70-79.

Twelve cases are under investigation and one case is a contact of previously confirmed cases.

The 14 new cases in Zone 5 (Campbellton region) are as follows:

  • four people 19 and under;
  • three people 30-39;
  • three people 40-49;
  • two people 50-59;
  • a person 70-79; and
  • a person 80-89.

Twelve cases are under investigation and two cases are contacts of previously confirmed cases.

The two cases in Zone 6 (Bathurst region) are as follows:

  • a person 50-59; and
  • a person 60-69.

Both cases are under investigation.

The one new case in Zone 7 (Miramichi region) is a person 80-89 and the case is under investigation.

Additional information is available on the COVID-19 dashboard.

POTENTIAL PUBLIC EXPOSURES

Anyone with symptoms of the virus, as well as anyone who has been at the site of a possible public exposure, is urged to request a test online to get an appointment.

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Biogen trial of ALS drug fails main goal, but company says data are encouraging

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A late-stage trial of Biogen Inc’s experimental treatment for an inherited form of Amyotrophic Lateral Sclerosis (ALS) failed to reach its main goal, but secondary measures and biomarkers showed favorable trends, the company said on Sunday.

Biogen will engage with regulators and other stakeholders “to understand the meaningfulness of this data and potential paths forward,” Toby Ferguson, head of the neuromuscular development unit at Biogen, told Reuters. The company is treating trial patients in a follow-on study and recently launched a Phase 3 trial of the drug, tofersen, in patients who are not yet experiencing ALS symptoms.

Tofersen, administered directly into the spinal canal each month, is designed to suppress the production of SOD1, a protein that can accumulate to toxic levels in ALS patients with mutations in a specific gene. Around 2% of ALS cases are believed to be caused by the genetic mutation.

After 28 weeks of treatment, the 108-patient trial showed a 1.2-point difference on a scale evaluating functional status for patients with fast-progressing ALS who were given tofersen compared to placebo patients, which was not statistically significant. In the group of patients with slower-progressing disease, the difference was 1.4 points.

An improvement of at least 2 points would be clinically meaningful, Guggenheim Partners said in a recent research report.

Biogen also detailed results from secondary trial endpoints, including breathing ability and muscular strength, indicating that patients treated with tofersen fared better than placebo patients, and that placebo patients switched to the drug in the extension phase of the study experienced similar gains.

“Despite the fact that there was no statistically significant difference in the primary endpoint, there is a clinical signal here,” said Dr. Timothy Miller, the study’s lead investigator and ALS Center Director at Washington University School of Medicine, St. Louis. He presented the tofersen data at the annual meeting of the American Neurological Association.

The trial also showed that patients given tofersen had lower levels of SOD1 protein compared to placebo patients, as well as lower levels of plasma neurofilament light chain, a potential marker of nerve cell degeneration.

“That suggests that there is an effect on clinical function of the person,” Dr. Miller said.

Most side effects in trial patients were mild to moderate, including headache and back pain, but two patients experienced spinal cord inflammation, and 5.6% of tofersen patients dropped out of the study.

Globally, around 168,000 people have ALS, a fatal neurological disorder also known as Lou Gehrig’s disease. Around 10% of cases are linked to genetic mutations, including SOD1.

Biogen, which licensed tofersen from Ionis Pharmaceuticals Inc, now plans to open early access to the drug to all patients with SOD1-associated ALS. In countries allowing such programs, patients can access a medicine free of charge before it is licensed commercially.

Shares of Biogen have fallen by about a third after hitting $414 in early June on the U.S. Food and Drug Administration’s controversial approval of Alzheimer‘s drug Aduhelm. The agency’s decision to approve the drug based on evidence that it removes protein plaques associated with the brain-wasting disease, rather than proof that it improves cognition, led to a backlash that has curtailed use of the medication while Medicare, the U.S. health plan for seniors, works to develop payment terms.

 

(Reporting By Deena Beasley; Editing by Andrea Ricci)

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