The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration (FDA) on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts are anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.
The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85 per cent protective against the most severe COVID-19 illness, in a massive study that spanned three continents — protection that remained strong even in countries such as South Africa, where the variants of most concern are spreading.
“This is really good news,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told The Associated Press Saturday. “The most important thing we can do right now is to get as many shots in as many arms as we can.”
Shipments of a few million doses to be divided among states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.
J&J also is seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization. Worldwide, the company aims to produce about 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain became the first to clear its use.
Health Canada is still reviewing the vaccine. Canada has ordered 10 million doses from Johnson & Johnson with options for up to 28 million more, if necessary. Most of those shots are expected to arrive by the end of September.
‘We’re champing at the bit to get more supply’
On Sunday, a U.S. advisory committee will meet to recommend how to prioritize use of the single-dose vaccine. And one big challenge is what the public wants to know: Which kind of vaccine is better?
“In this environment, whatever you can get — get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the vaccine’s benefits outweigh its risks.
Data is mixed on how well all the vaccines being used around the world work, prompting reports in some countries of people refusing one kind to wait for another.
WATCH | Will Canadians be able to choose which vaccine they get?:
In the U.S., the two-dose Pfizer and Moderna shots were 95 per cent protective against symptomatic COVID-19. J&J’s one-dose effectiveness of 85 per cent against severe COVID-19 dropped to 66 per cent when moderate cases were rolled in. But there’s no apples-to-apples comparison because of differences in when and where each company conducted its studies, with the Pfizer and Moderna research finished before concerning variants began spreading.
Collins said the evidence of effectiveness shows no reason to favour one vaccine over another.
“What people I think are mostly interested in is, is it going to keep me from getting really sick?” Collins said. “Will it keep me from dying from this terrible disease? The good news is all of these say yes to that.”
Also, J&J is testing two doses of its vaccine in a separate large study. Collins said if a second dose eventually is deemed better, people who got one earlier would be offered another.
The FDA cautioned that it’s too early to tell if someone who gets a mild or asymptomatic infection despite vaccination still could spread the virus.
There are clear advantages aside from the convenience of one shot. Local health officials are looking to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors who are spending months on fishing vessels — communities where it’s hard to be sure someone will come back in three to four weeks for a second vaccination.
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The J&J vaccine also is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
“We’re champing at the bit to get more supply. That’s the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staffers were readying electronic health records, staffing and vaccine storage in anticipation of offering J&J shots soon.
The FDA said studies detected no serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache.
The FDA said there is “a remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with the Pfizer and Moderna vaccines.
The vaccine has been authorized for emergency use in adults 18 and older for now. But like other vaccine makers, J&J is about to begin a study of its vaccine in teens before moving to younger children later in the year, and also plans a study in pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spike protein that coats it. But they’re made in very different ways.
WATCH | Provinces offer different timelines for COVID-19 vaccine rollout:
J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along. It’s the same technology the company used in making an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca and China’s CanSino Biologics.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make those harmless spike copies.
The AstraZeneca vaccine — which was approved for use in Canada on Friday and is already in use in numerous other countries — is finishing a large U.S. study needed for FDA clearance. Also in the pipeline, Novavax uses a still different technology, made with lab-grown copies of the spike protein, and has reported preliminary findings from a British study suggesting strong protection.
Still other countries are using “inactivated vaccines,” made with killed coronavirus by Chinese companies Sinovac and Sinopharm.
Early Robinhood investor Jason Calacanis on trading app's imminent IPO – CNBC Television
Robinhood Flirts With Worst Debut Ever for IPO of Its Size – BNN
(Bloomberg) — Robinhood Markets Inc. wanted to make history with its initial public offering, and now it might — for the wrong reason.
Shares in the broker behind the meme-stock revolution fell as much as 12% below the IPO price in the company’s first trading session. That puts the stock in the running to rank as the worst debut on record among U.S. firms that raised as much cash as Robinhood or more, according to data compiled by Bloomberg.
Shares rebounded and were last trading 1% lower at $37.52 mid-afternoon in New York.
Robinhood must finish Thursday’s session at $34.90 or higher, or else it will replace the 2007 IPO by another brokerage, MF Global Holdings Ltd., as the worst debut among qualifying firms. MF Global ended its first day down 8.2%.
Read more: Robinhood Loses More Ground in Trading Debut After Muted IPO
The stock opened at the $38 initial public offering price. For an IPO of Robinhood’s size and larger, that’s the weakest opening trade since Uber Technologies Inc. in May of 2019 among U.S. firms. Uber finished its debut session down 7.6%.
©2021 Bloomberg L.P.
Google and Facebook will require U.S. workers to be vaccinated to return to the office – CBC.ca
Google is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened.
The more highly contagious delta variant of the coronavirus is driving a dramatic spike in COVID-19 cases and hospitalizations.
Google’s announcement Wednesday was shortly followed by one from Facebook, which also said it will make vaccines mandatory for U.S. employees who work in offices. Exceptions will be made for medical and other reasons.
“With regards to our Canadian offices, we don’t have specifics to share yet,” a spokesperson for Facebook told CBC News. “We will be evaluating our approach in other regions as the situation evolves.”
In an email sent to Google’s more than 130,000 employees worldwide, CEO Sundar Pichai said the company is now aiming to have most of its workforce back to its offices beginning Oct. 18, instead of its previous target date of Sept. 1.
The decision also affects tens of thousands of contractors who Google intends to continue to pay while access to its campuses remains limited.
“This extension will allow us time to ramp back into work while providing flexibility for those who need it,” Pichai wrote.
Pichai disclosed that once offices are fully reopened, everyone working there will have to be vaccinated. The requirement will be first imposed at Google’s Mountain View, Calif., headquarters and other U.S. offices, before being extended to the more than 40 other countries where Google operates.
‘The stuff that needs to be done’
Google has extensive operations in Canada, but the company did not immediately reply to a request for comment as to when such a policy may be implemented for its Canadian work force. Pichai’s letter, however, makes it clear that it is not just a U.S. policy.
“We’re rolling this policy out in the U.S. in the coming weeks and will expand to other regions in the coming months,” he said.
WATCH | How social media is helping spread misinformation like a virus:
Public health experts are lauding the move.
“This is the stuff that needs to be done, because otherwise we are endangering workers and their families,” said Dr. Leana Wen, a public health professor at George Washington University and a former health commissioner for the city of Baltimore.
“It is not fair to parents to be expected to come back to work and sit shoulder-to-shoulder with unvaccinated people who could be carrying a potentially deadly virus.”
Because children under the age of 12 aren’t currently eligible to be vaccinated, parents can bring the virus home to them from the office if they are around unvaccinated colleagues, Wen said.
Various government agencies already have announced demands for all their employees to be vaccinated, but the corporate world so far has been taking a more measured approach, even though most lawyers believe the mandates are legal.
Most employers hesitant to require vaccines
Delta and United airlines are requiring new employees to show proof of vaccination. Goldman Sachs and Morgan Stanley are requiring their employees to disclose their vaccination status, but are not requiring staffers to be vaccinated.
Less than 10 per cent of employers have said they intend to require all employees to be vaccinated, based on periodic surveys by the research firm Gartner.
While other major technology companies may follow suit now that Google and Facebook have taken stands on vaccines, employers in other industries still may be reluctant, predicted Brian Kropp, chief of research for Gartner’s human resources practice.
“Google is seen as being such a different kind of company that I think it’s going to take one or two more big employers to do something similar in terms of becoming a game changer,” Kropp said.
Google’s vaccine mandate will be adjusted to adhere to the laws and regulations of each location, Pichai wrote, and exceptions will be made for medical and other “protected” reasons.
“Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead,” Pichai explained.
The rapid rise in cases during the past month has prompted more public health officials to urge stricter measures to help overcome vaccine skepticism and misinformation.
It’s unclear how many of Google’s workers still haven’t been vaccinated. In his email, Pichai described the vaccination rate at the company as high.
Remote work still going strong
Google’s decision to extend its remote work follows a similar move by another technology powerhouse, Apple, which recently moved its return-to-office plans from September to October, too.
The delays by Apple and Google could influence other major employers to take similar precautions, given that the technology industry has been at the forefront of the shift to remote work triggered by the spread of the novel coronavirus.
Even before the World Health Organization declared a pandemic in March 2020, Google, Apple and many other prominent tech firms had been telling their employees to work from home.
WATCH | Business travel particularly slow to bounce back:
This marks the third time Google has pushed back the date for fully reopening its offices.
Google’s vaccine requirement also could embolden other employers to issue similar mandates to guard against outbreaks and minimize the need to wear masks in the office.
While most companies are planning to bring back their workers at least a few days a week, others in the tech industry have decided to let employees do their jobs from remote locations permanently.
Pierre Elliott Trudeau
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