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Next on FDA's agenda: Booster shots of Moderna, J&J vaccines – Winnipeg Free Press

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FILE – This May 13, 2021, file photo shows syringes filled with the Johnson & Johnson vaccine at a mobile vaccination site in Miami. Starting Thursday, Oct. 14, 2021, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Wilfredo Lee, File)

WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn.

Federal regulators begin tackling that question this week.

On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week.

After the FDA advisers give their recommendation, the agency itself will make a decision on whether to authorize boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them. Its decision is subject to approval by the CDC director.

The process is meant to bolster public confidence in the vaccines. But it has already led to conflicts and disagreements among experts and agencies.

For example, last month the CDC advisory panel backed Pfizer boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems. But CDC Director Dr. Rochelle Walensky overruled her advisers and decided boosters should also be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions more Americans to the list.

Some health experts fear the back-and-forth deliberations are muddling the public effort to persuade the unvaccinated to get their first shots. They worry that the talk of boosters will lead people to wrongly doubt the effectiveness of the vaccines in the first place.


FILE - In this May 21, 2021, file photo, two people wait to receive the Moderna COVID-19 vaccine at Providence Edwards Lifesciences vaccination site in Santa Ana, Calif. Starting Thursday, Oct. 14, 2021, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Jae C. Hong, File)

FILE – In this May 21, 2021, file photo, two people wait to receive the Moderna COVID-19 vaccine at Providence Edwards Lifesciences vaccination site in Santa Ana, Calif. Starting Thursday, Oct. 14, 2021, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Jae C. Hong, File)

As the FDA’s panel meets to review the Moderna and J&J vaccines, its decisions this time are likely to be even more complicated, with experts discussing whether a third Moderna shot should contain just half the original dose and what’s the best timing for a second shot of the single-dose J&J vaccine.

The panel will also look into the safety and effectiveness of mixing-and-matching different brands of vaccine, something regulators have not endorsed so far.

An estimated 103 million Americans are fully vaccinated with Pfizer’s formula, 69 million with Moderna’s and 15 million with J&J’s, according to the CDC. Regulators took up the question of Pfizer boosters first because the company submitted its data ahead of the other vaccine makers.

The two initial Moderna shots contain 100 micrograms of vaccine each. But the drugmaker says 50 micrograms ought to be enough for a booster for healthy people.

A company study of 344 people gave them a 50-microgram shot six months after their second dose, and levels of virus-fighting antibodies jumped. Moderna said the booster even triggered a 42-fold rise in antibodies able to target the extra-contagious delta variant.

Side effects were similar to the fevers and aches that Moderna recipients commonly experience after their second regular shot, the company said.

As for people who got the J&J vaccine, the company submitted data to the FDA for different options: a booster shot at two months or at six months. The company did not signal its preference.

J&J released data in September showing that a booster given at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet disclosed patient data on a six-month booster, but early measures of virus-fighting antibodies suggest it provides even higher protection.

Even without a booster, J&J says, its vaccine remains about 80% effective at preventing COVID-19 hospitalizations in the U.S.

Scientists emphasize that all three vaccines used in the U.S. still offer strong protection against severe disease and death from COVID-19. The issue is how quickly, and how much, protection against milder infection may wane.

In one recent study, researchers compared about 14,000 people who had gotten their first Moderna dose a year ago with 11,000 vaccinated eight months ago. As the delta variant surged in July and August, the more recently vaccinated group had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.

Still, medical experts continue to debate the science and rationale for giving extra shots to those who already have significant protection.

The White House and its top medical advisers announced sweeping plans in August to offer boosters to nearly all adults, citing signs of waning protection and the then-surging delta variant. But they were rebuffed by many experts who said there is little data showing whether such broad use would stop breakthrough infections or curb the overall trajectory of cases.

While the FDA and CDC ultimately scaled back use of Pfizer boosters, Biden administration officials, including Dr. Anthony Fauci, have suggested that extra shots will eventually be recommended for most Americans.

They point to data from Israel showing lower rates of infections and severe disease among people who received a third Pfizer shot.

The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average, an increase of more than 50% over the past two weeks. The rise has been driven mainly by Pfizer boosters and employer vaccine mandates.

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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.

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Nova Scotia reports 23 new COVID-19 cases, 26 recoveries – Vancouver Is Awesome

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HALIFAX — Nova Scotia is reporting 23 new cases of COVID-19.

Thirteen cases have been identified in the central zone, which includes Halifax, six cases are in the western zone, three cases have been found in the northern zone and one case is in the eastern zone.

Authorities say 26 recoveries have also been reported.

The province now has 160 active infections with 15 people in hospital, four of whom are in intensive care.

Officials also reported that two schools received COVID-19 exposure notices Thursday, both of them in the Amherst area.

And officials continue to monitor an outbreak of the disease in a non-COVID unit at Valley Regional Hospital in Kentville where five cases of COVID-19 have been identified.

This report by The Canadian Press was first published Oct. 22, 2021.

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This story was produced with the financial assistance of the Facebook and Canadian Press News Fellowship.

The Canadian Press

Note to readers: This is a corrected story. A previous version based on an erroneous Health Department news release said there were 11 people in hospital.

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Get COVID-19 and flu shot at the same time – Windsor Star

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You can get a COVID-19 vaccination and annual flu shot at the same time, Windsor Essex County Health Unit director of health protection Kristy McBeth said Thursday.

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The National Advisory Committee on Immunization, which makes recommendations on the use of vaccines in Canada, recommended recently that the COVID-19 vaccine can be administered at the same time or any time before or after other vaccines, including the flu shot.

Previously, the committee had recommended that COVID-19 vaccines be administered at least 28 days before or 14 days after other shots as a precautionary measure.

After reviewing the evolving evidence on COVID-19 vaccines and considering the extensive data on administering other routine vaccines at the same time or within days of each other, the committee has determined that the earlier, precautionary approach is no longer necessary.

The new recommendation is expected to help the rollout of the flu shot this fall as well as make it easier for people to get  other vaccines they may have missed during the pandemic.

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The flu shot is free in Ontario and available at doctors’ offices and pharmacies. Hospitals, long-term care homes, doctors’ offices, walk-in clinics and pharmacies here have already received their supplies.

People over age 65 and those at risk of complications from flu have been given priority and are receiving the vaccine now. The shot will be available to the general public in November.

The health unit will begin promoting the shot more widely next month.

“We will be doing some extra promotion, urging people to get it,” McBeth told the health unit’s board of directors.

Between 150,000 and 200,000 doses are expected to be administered here this season, up from 97,000 last year.

Ontario has ordered 7.6 million doses this year, 1.4 million more than last year, Health Minister Christine Elliott said Tuesday.

There were few cases of flu last season because many people worked from home, their children learned remotely and the economy and society were locked down.

But more cases are expected this season because many people have returned to offices, schools have reopened and many restrictions have been lifted, allowing people to be out in the community more and to socialize and travel.

People are being urged to get the flu shot to avoid overwhelming hospitals that are still caring for COVID-19 patients.

ajarvis@postmedia.com

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Canada scraps COVID-19 travel advisory; Ontario to end mask, vaccine rules by March

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Canada has scrapped an official advisory urging its citizens to shun  non-essential foreign travel, given its successful campaign to inoculate people against COVID-19, the country’s top medical officer said on Friday.

Hours later, Canada’s most populous province, Ontario, issued a timeline to lift all remaining COVID-19 restrictions, with the aim of removing all proof of vaccination and mask requirements by March 2022.

Canada’s travel warning was issued in March 2020, when the COVID-19 pandemic erupted.

Ottawa removed the advice to avoid unnecessary travel late on Thursday, however it is still telling people to avoid cruise ship travel outside of the country.

“The beginnings of the transition away from the more blanket approach really recognizes vaccines are very effective at preventing severe outcome,” Chief Medical Officer Theresa Tam told a briefing.

According to official data, just under 82% of eligible Canadians had been fully vaccinated against COVID-19 by Oct 8.

Tam said the latest surveillance data showed “a continued decline in disease activity nationally and in most jurisdictions.”

“Now is not the time to just freely go wherever,” she added, citing high cases of coronavirus in some nations.

Ontario laid out a six-month timeline to lift all COVID-19 restrictions, starting with removing capacity limits in the “vast majority” of public venues on Oct. 25, and culminating in an end to all mask and proof of vaccination requirements by March.

The timeline will be dependent on “the absence of concerning (pandemic) trends,” it said in a statement.

“This plan is built for the long term,” Premier Doug Ford said. “It will guide us safely through the winter and out of this pandemic, while avoiding lockdowns and ensuring we don’t lose the hard-fought gains we have made.”

Ontario spent much of the past 18 months in some form of  lockdown due to high infection rates and hospital bed occupancy of COVID-19 patients.

(Reporting by David Ljunggren in Ottawa and Moira Warburton in Vancouver; Editing by Paul Simao and Bill Berkrot)

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