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U.S. FDA advisory panel rejects widespread Pfizer booster shots – CTV News

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WASHINGTON —
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.

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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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Goldman Sachs moves to full ownership of China securities JV

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Goldman Sachs said on Sunday it received approval from China’s securities regulator to take full control of its mainland securities business.

The U.S. bank said it would buy the remainder of Goldman Sachs Gao Hua Securities Company Ltd (GSGH), and rename it as Goldman Sachs (China) Securities Company Ltd.

The migration of its onshore business units to GSGH from Beijing Gao Hua Securities was underway, it added.

“This marks the start of a new chapter for our China business following a successful 17-year joint venture,” Goldman Sachs said in a statement.

It becomes the second Wall Street firm to be granted approval to shift to full ownership of its securities business after JPMorgan Chase & Co moved to 100% in August https://www.reuters.com/business/finance/jpmorgan-gets-beijings-approval-first-fully-foreign-owned-brokerage-2021-08-06.

Securities businesses in China typically house investment banking, research, equities and fixed income businesses.

Unlike most of the other China JVs, Goldman had day-to-day operational control of its business even with its minority ownership.

Lucrative underwriting fees on equity and bond transactions – especially initial public offerings (IPOs) – in China’s expanding capital markets has been the driving force for Western banks to increase stakes in their mainland business.

Full ownership could allow foreign banks to expand their operations in the multi-trillion-dollar Chinese financial sector, and better integrate them with their global businesses.

Morgan Stanley currently owns 90% of its securities joint venture with partner Shanghai Chinafortune Co Ltd after increasing its stake https://www.reuters.com/business/finance/morgan-stanley-nears-full-ownership-china-ventures-with-stake-buys-2021-05-28 in May.

China’s regulators had examined Goldman Sach’s application to move to full ownership https://www.reuters.com/business/finance/goldman-sachs-signs-pact-wholly-own-china-joint-venture-2020-12-11 since the bank flagged its intention to buy out its partner in December.

(Reporting by Scott Murdoch in Hong Kong and Nikhil Kurian Nainan in Bengaluru; editing by Uttaresh.V and Stephen Coates)

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From Canada? Want to go to the U.S.A.? Better have the right vaccine – Boing Boing

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The last couple of years have been hard on Canadian Snowbirds. Many of us, myself included, are used to heading south in the fall, to escape the icy bullshit of a Canadian winter. Unfortunately, thanks to COVID-19, a lot of us have been trapped, north of the wall, since March 2020. 

I’ve been fine with this. 

When the land border was closed down to everyone but essential travellers, my mindset was that if I was going to get sick, I’d just as soon do it in my own nation where healthcare is free (yeah, we pay our taxes, but still.) Then, last winter, the vaccines started to roll out. By early spring, both my wife and I had been injected with two doses of Pfizer’s version of the brew. We breathed a sigh of relief and began to hope that we might, one day soon, be able to start our travels again. I’m sure that lots of other folks did too. Unfortunately, depending on where in Canada they live, it wasn’t a sure bet that they’d wind up with two doses of the same vaccine. In the rush to get as many Canadians vaccinated against the plague as possible, many provinces started mixing and matching whichever vaccines that they had on hand.

So, you could wind up with Pfizer for your first jab and Moderna for your second. It’s cool, they told us. Mixing vaccines affords tons of protection, we were assured. Why, we’d all be able to get back to our lives in no time… provided said life doesn’t include travelling to one of many countries where vaccine mixing is considered to be a dangerous load of bullshit. You may have guessed by now, that America is one of those countries.  

From The CBC:

…at the same time the U.S. reopens the land border, it will start requiring that foreign land and air travellers entering the country be fully vaccinated.

The U.S. Centers for Disease Control (CDC) currently doesn’t recognize mixed COVID-19 vaccines — such as one dose of AstraZeneca, and one dose of Pfizer or Moderna — and hasn’t yet said if travellers with two different doses will be blocked from entry when the vaccine requirement kicks in.

So that sucks. 

According to the CBC, the Centers for Disease Control and Prevention might soon consider changing their stance on mixed vaccines. I’d like to think that a crap load of data on the effectiveness of mixed vaccine dosing will play into such a decision. No matter how badly folks might want to head south for the winter, Americans deserve to be as safe as they can be. 

In the meantime, I suspect that, just like last fall, many snowbirds will wind up on Vancouver Island, where I hang my hat, these days. It’s warm enough here that living in an RV is both possible and comfortable.

But I’ll tell ya, it’s a far cry from kicking back in the trade winds on the cusp of Texas’ southern border.

Image via Wikipedia Commons

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Travel industry, health experts applaud U.S. decision to allow travellers with mixed doses – CTV News

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TORONTO —
The organization representing Canada’s tourism industry is applauding the U.S. government’s decision to allow Canadian travellers with mixed vaccine doses once the border opens in November.

On Friday, the U.S. Centers for Disease Control and Prevention confirmed that travellers with “any combination” of two doses of vaccines approved by the World Health Organization or the U.S. Food and Drug Administration “are considered fully vaccinated.”

Beth Potter, who is president and CEO of the Tourism Industry Association of Canada, says the announcement is “really good news.”

“What it does is it provides a little bit more clarity, and this is something that we’ve talked about a lot. We know now that if you’ve got that mixed dose, as of November you’re going to be able to enter into the United States,” she told CTV News Channel on Saturday.

Infectious disease expert Isaac Bogoch of the University Health Network in Toronto says allowing mixed dosed travellers is “a smart and data driven approach.”

“This will be a huge relief to many Canadians who did the right thing and got vaccinated and even took those mixed and matched vaccine approaches. It’s safe, it’s effective, and now there’s a recognition of this,” Bogoch said in an interview with CTV News Channel on Saturday.

“I’m really happy to hear this. It’s about time.”

This announcement came after the White House confirmed that the U.S. land borders with Canada and Mexico would be open to fully vaccinated tourists by Nov. 8.

On the American side, the U.S. Travel Association also applauded the Biden Administration’s plans to reopen the border.

“Reopening to international visitors will provide a jolt to the economy and accelerate the return of travel-related jobs that were lost due to travel restrictions,” said association president and CEO Roger Dow in a statement on Friday.

“We applaud the administration for recognizing the value of international travel to our economy and our country, and for working to safely reopen our borders and reconnect America to the world.”

But while the U.S. won’t require Canadians to show proof of vaccination to cross, returning to Canada requires a negative PCR test conducted at most 72 hours before crossing the border.

PCR tests can cost upwards of $200. The Canadian government does not accept rapid antigen tests, which can be had for only $40.

Brian Higgins, a New York congressman whose district includes the border cities of Buffalo and Niagara Falls, wants to see Canada drop the COVID-19 PCR test requirement.

“I think that the U.S. decision to allow Canadians coming into the United States without a test again underscores the potency of the vaccine,” Higgins told The Canadian Press on Friday. “I would like to see that reciprocated by our Canadian neighbours.”

However, Public Safety Minister Bill Blair said that Canada will continue to require PCR tests so long as the Public Health Agency of Canada advocates for it.

“We’ve seen throughout the pandemic that advice has evolved as new evidence and new data is available. We’ll continue to follow the advice in the Public Health Agency Canada​,” he said in an ​interview with CTV’s Question Period on Sunday.

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