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US FDA panel okays COVID-19 booster jabs for people over 65 – Al Jazeera English

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Recommendation comes after science advisory panel rejects Pfizer proposal to provide booster jabs to most people.

A United States Food and Drug Administration (FDA) advisory panel has given approval to a booster jab of the Pfizer COVID-19 vaccine for people over the age of 65 and others at high risk of the disease.

But the influential FDA panel of scientists on Friday rejected widespread delivery of boosters to most Americans, delivering a surprise blow to the Biden administration’s plan to combat the highly contagious Delta variant by rolling out third jabs of the vaccine next week.

Members of the FDA’s panel of outside experts voted unanimously to support boosters for older Americans and at-risk people after rejecting Pfizer’s proposal to provide boosters of the vaccine to the general public.

The FDA’s move to clear the way for booster jabs only for older and at-risk people came as President Joe Biden planned to host a COVID-19 summit on the sidelines of the United Nations General Assembly in New York next week.

The US has been pushing partner nations to increase the availability of vaccines worldwide. The World Health Organization has urged the US to hold off providing boosters to its citizens until more of the worldwide population has received an initial inoculation.

“We will be asking participants to commit to a higher level of ambition” on a “common vision for defeating COVID-19 together”, White press secretary Jen Psaki said in a statement.

During several hours of discussion, the FDA panel of scientific advisers voiced frustration that Pfizer had provided little data on the safety of extra doses. And they complained information provided by Israeli researchers about their booster campaign was not useful for predicting the US experience.

Pfizer Inc and its German partner BioNTech, as well as rival vaccine maker Moderna Inc, have presented analyses of clinical trials showing that the effectiveness of the vaccines wanes over time.

As a result, people who were vaccinated earlier on in the pandemic are now more vulnerable to infections, particularly in the face of the fast-spreading Delta variant of coronavirus.

Booster doses help restore the waning levels of antibodies produced by the original inoculation, the drugmakers have said.

Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them but some of the agency’s top scientists arguing they are not needed yet.

Members of the advisory panel said the Pfizer and the FDA request for approval for people as young as 16 years old is too broad. Most of them said they would support boosters for older Americans, but did not think they were needed yet for younger adults.

Many vaccine experts said the data so far only suggested a need for boosters in older adults and people with compromised immune systems. The critics include two FDA scientists who resigned as the Biden administration announced its booster shot plans.

A separate panel advising the US Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House said it was ready to roll out boosters next week if health officials approve the plan. That programme now is likely to be narrowed in light of the advisory panel’s views and the FDA’s partial approval of the use of boosters.

A report published in The Lancet medical journal on September 13 concluded that even with the threat of the more contagious Delta variant, “booster doses for the general population are not appropriate at this stage in the pandemic.”

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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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