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Moderna to begin trial of new COVID vaccine to address virus variant first found in South Africa – USA TODAY

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Karen Weintraub
 
| USA TODAY

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Mobile clinic helps distribute COVID-19 vaccine at DC church

In the District today, a pilot program using churches to help distribute the coronavirus vaccine was introduced.

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CAMBRIDGE, Mass. — Moderna, which makes one of the two authorized COVID-19 vaccines, is set to launch a clinical trial of a new vaccine designed to combat a variant of the virus, the company announced Wednesday. 

The company says it has produced enough of its variant-specific candidate vaccine, called mRNA-1273.351 to begin testing it in people.

Any change to address variants, which other vaccine makers also are working on, would need to be approved by the U.S. Food and Drug Administration. 

In a study published last week, Moderna showed that blood from people who received the current vaccine includes neutralizing antibodies against the major known variants. But only one-sixth of their antibodies were protective against the B.1.351 variant of the virus, which originated in South Africa, and which is the target of its new vaccine. 

It is not clear whether this reduced antibody level is sufficient to protect people against symptomatic or serious cases of COVID-19 from this new variant.

That’s why “out of an abundance of caution,” the company said in a news release it has begun pursuing two possible strategies against the variant: giving people a booster dose of the original vaccine to increase antibody levels, and developing two variant-specific vaccines, which could be given instead of the original one.

It will test several variations of a booster, the company said, including a single, low-dose shot of the variant-specific vaccine; a shot that includes both the original vaccine and the variant-specific one; and a third low-dose version of the original vaccine. 

According to FDA guidance, the company plans to evaluate the safety and immune effects of these approaches in people who have not been vaccinated against COVID-19 and in those who received the original vaccine, mRNA-1273.

The National Institute of Allergy and Infectious Disease will help lead the clinical studies to see if mRNA-1273.351 can boost immunity against the variant. In its announcement Wednesday, the company said it already has shipped sufficient doses of this variant-specific vaccine needed for testing. 

“As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge,” Stéphane Bancel, Moderna’s CEO, said in a prepared statement, referring to the virus that causes COVID-19. “We are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic.”

The lower doses hopefully will work for the booster, Bancel said, allowing the company to stretch its limited vaccine supply.

Other leaders in the COVID-19 vaccine effort – Pfizer-BioNTech, Novavax, Johnson & Johnson and AstraZeneca-Oxford University – also have said they are working on new versions of their vaccines or boosters to increase their protection.

A third vaccine on the way: One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds

It’s not yet clear whether a booster shot, which amps up the immune system, will be enough to protect against a new variant, or if an entirely new vaccine is needed.

Moderna is the first to release details about its effort. 

In a Congressional subcommittee meeting Tuesday, Pfizer’s chief business officer, John Young, said his company is “preparing to respond quickly to initiate a study to investigate the effectiveness of a third booster of our vaccine in trial participants who have already received two doses.”

He said Pfizer is discussing trial designs with the FDA. “We will fight every step of the way until a devastating pandemic is under control,” he said.

The Moderna vaccine, like the Pfizer-BioNTech one, is based on mRNA technology in which a simple change to the code will enable the recipient to make a slightly different protein. That’s why they were both made so quickly last year, once it became clear which protein on the SARS-CoV-2 virus they should target. By getting the body to produce a protein from the virus, the vaccine trains the immune system to recognize that protein and immediately attack if the recipient is exposed to the virus.

On Monday, the FDA laid out guidelines for companies that want to change their vaccines to adapt to new variants. They will not be required to start from scratch, running gigantic clinical trials over many months as they have to win FDA authorization.

Instead, as with the flu vaccine, which is altered every year to cope with changing strains, COVID-19 vaccine versions will be tested in smaller groups to confirm safety and to examine immune responses for effectiveness.

Lab studies and some real-world evidence suggests that current vaccines will remain effective against a variant called B.1.1.7, which originated in the United Kingdom.

Lessons from the UK: COVID-19 variant found in UK spreads ‘like wildfire.’ British experts fear what will happen if US won’t lock down

But they may not all work against B.1.351. Studies of AstraZeneca-Oxford University’s collaborative vaccine showed it was barely protective at all against B.1.351 in South Africa, and that country has passed on using doses of the vaccine.

Johnson & Johnson’s vaccine does seem to provide some protection there, and lab studies suggest that Pfizer-BioNTech’s vaccine, like Moderna’s, would continue to provide some protection against that variant, though it’s not clear how much.

Even if it proves unnecessary to reconfigure vaccines to fight the B.1.351 variant, there may be another that comes along that will require a new vaccine, public health officials have said.

New variants of the virus will continue to emerge as COVID-19 continues to infect people across the globe. The only way to stop these variants is to reduce the spread of the virus, public health officials, including Dr. Anthony Fauci, America’s top infectious disease doctor, have said.

“It really is the time to study effects of booster doses to new, emerging viral variants,” Dr. Jesse Goodman, a professor of Medicine at Georgetown University and former chief scientist with the FDA, said in a Wednesday call with media.

Studies are needed to show whether people respond as expected to booster doses, and whether they cause any concerning safety problems. 

And even if the virus doesn’t escape protection from current vaccines, people might need boosters eventually, Goodman said.

“We don’t know,” he said, “how long immunity will last from these vaccines.” 

Contact Karen Weintraub at kweintraub@usatoday.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Vaccinated should wear masks indoors in US COVID hotspots: CDC – Al Jazeera English

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People in parts of the United States where COVID-19 infections are surging should wear masks indoors even if they are fully vaccinated against the coronavirus, the country’s public health agency has advised.

Citing new information about the ability of the Delta variant to spread among vaccinated people, the US Centers for Disease Control and Prevention (CDC) on Tuesday also recommended indoor masks for all teachers, staff, students and visitors to schools, regardless of vaccination status.

“In areas with substantial and high transmission, CDC recommends fully vaccinated people wear masks in public, indoor settings to help prevent the spread of the Delta variant and help protect others,” CDC Director Rochelle Walensky told reporters during an afternoon news briefing.

The US is averaging more than 57,000 coronavirus cases a day and 24,000 hospitalisations, and public health officials for weeks have warned that COVID-19 infections are increasing, especially in parts of the country with low vaccination rates.

Walensky said while vaccinated Americans represent “a very small amount of transmission” – and stressed that the vast majority of new infections, hospitalisations and deaths is occurring among unvaccinated individuals – vaccinated people still have the ability to pass the virus on to others.

“With the Delta variant, vaccinating more Americans now is more urgent than ever,” she added.

Rising infections

The recent rise in cases comes after mask-wearing and other public health restrictions were loosened, and restaurants, bars and other venues reopened in many parts of the country amid a sharp increase in national vaccination rates.

The new CDC recommendations are not binding and many Americans, especially in Republican-leaning states, may choose not to follow them.

“This is not a decision that we … have made lightly,” Walensky said about the new guidelines, acknowledging that many people are frustrated by the ongoing pandemic. “This new data weighs heavily on me, this new guidance weighs heavily on me.”

US President Joe Biden welcomed the agency’s recommendations on Tuesday as “another step on our journey to defeating this virus”.

“I hope all Americans who live in the areas covered by the CDC guidance will follow it,” Biden said in a statement, adding that masking students in schools “is inconvenient … but will allow them to learn and be with their classmates with the best available protection”.

“Most importantly, today’s announcement also makes clear that the most important protection we have against the Delta variant is to get vaccinated. Although most U.S. adults are vaccinated, too many are not. While we have seen an increase in vaccinations in recent days, we still need to do better,” Biden said.

The CDC had advised people to wear masks for much of the pandemic in settings where they could not maintain six feet (1.8 metres) of distance between themselves and others.

In April, as vaccination rates rose sharply, the agency eased its guidelines on the wearing of masks outdoors, saying that fully vaccinated Americans no longer needed to cover their faces unless they were in a big crowd of strangers. In May, the guidance was eased further for fully vaccinated people, allowing them to stop wearing masks outdoors in crowds and in most indoor settings.

The guidance still called for wearing masks in crowded indoor settings, like buses, planes, hospitals, prisons and homeless shelters, but it cleared the way for reopening workplaces and other venues.

Subsequent CDC guidance said fully vaccinated people no longer needed to wear masks at summer camps or at schools, either.

Some municipalities and states have re-imposed mask mandates amid the recent increase in cases. [File: Brendan McDermid/Reuters]

Coronavirus vaccines are widely available across the US, and 60 percent of adults are fully vaccinated while 69 percent have received at least one dose, according to CDC data. But millions of people remain unvaccinated – and the recent increase in cases is especially pronounced in US states with low vaccination rates, such as Florida.

‘Wrong direction’

Dr Anthony Fauci, the White House chief medical adviser, warned during the weekend that the US was moving “in the wrong direction” on the coronavirus – and he urged people to get jabs.

“If you look at the inflection of the curve of new infections,” Fauci said in an interview on CNN’s State of the Union programme on Sunday, stressing that most infections are among Americans who have not been vaccinated.

“It is among the unvaccinated and since we have 50 percent of the country is not fully vaccinated, that’s a problem – particularly when you have a variant like Delta which has this extraordinary characteristic of being able to spread very efficiently and very easily from person to person,” he said.

Some municipalities and states have re-imposed mask mandates amid the increase in cases.

In St Louis, Missouri, a county-wide mask mandate took effect on Monday, requiring most people, regardless of their vaccination status, to wear a mask indoors and on public transportation.

Sixty percent of US adults are fully vaccinated while 69 percent have received at least one dose, according to data from the CDC [File: Karen Pulfer Focht/Reuters]

Los Angeles, California also recently reinstated its mask requirement, while the top public health official in King County, Washington, which includes the city of Seattle, last week asked everyone to wear masks in indoor public spaces – even if they are vaccinated.

Calls have also grown to require health workers, among others, to be vaccinated.

“Due to the recent COVID-19 surge and the availability of safe and effective vaccines, our health care organizations and societies advocate that all health care and long-term care employers require their workers to receive the COVID-19 vaccine,” a group of more than 50 healthcare organisations, including the American Medical Association, said on Monday.

That same day, the US Department of Veterans Affairs said it would require its doctors and other medical staff to get COVID-19 vaccines, becoming the first federal agency to impose such a mandate.

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BC Steps Up Measures to Increase Vaccinations – Yahoo News Canada

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British Columbia’s vaccination strategy is changing course to target the more than 900,000 eligible people who are not yet immunized against COVID-19.

The Vax For BC campaign will see mass vaccination clinics scale down to make way for smaller community-based clinics, drop-in centres and mobile vaccination clinics to meet people where they are.

The interval between shots will drop from eight weeks to seven, and as low as six in regions with particularly low vaccination rates.

And the province will make 20,000 shots available without appointments on “Walk-in Wednesday,” Aug. 4, in addition to freeing up more shots at every location for walk-ins.

“We are making it even easier for people to get vaccinated to protect themselves and their loved ones against COVID-19,” said provincial health officer Dr. Bonnie Henry on Tuesday.

More than 80 per cent of people over 12 in B.C. have received at least one dose of a COVID-19 vaccine, an effort that public health officials said should be commended.

But the missing 19.6 per cent, “those 900,000 are really, really important” to prevent a fourth wave of the virus in B.C., Dr. Penny Ballem said today.

“We’ve had incredible success and commitment by the public,” said Ballem, who is in charge of the vaccine rollout. “But we have to keep going, and we have to capture more people.”

Unvaccinated people accounted for about 78 per cent of COVID-19 cases between June 15 and July 15, despite representing only 19.6 per cent of the population.

Those who had a single dose accounted for 18 per cent of cases. And fewer than five per cent of cases involved people who were fully vaccinated.

Overall, vaccinations are preventing about 70 per cent of potential infections, according to recent provincial modelling.

“It is extremely important to get both doses of the vaccine,” said Henry.

The recent slow increase in daily and active cases is still largely driven by social gatherings and events with unvaccinated people, Henry said, most of which are in the Interior.

“We don’t yet have enough people with full protection that it can’t spread,” Henry said.

Increasing vaccinations is particularly important in the Northern and Interior Health regions, Henry said, where long travel times from small communities to existing clinics can make it difficult to get vaccinated.

The regional differences are stark. In Northern Health, 32.5 per cent of the eligible population has not received any vaccine, more than double the 14.8 per cent who are unvaccinated in Vancouver Coastal Health.

In Interior Health, where nearly two-thirds of recent cases have been located, 26.2 per cent of the population is unvaccinated.

When asked about how much of that is due to access and how much is due to vaccine hesitancy or anti-vax sentiments, Henry said the province estimates only about five per cent of people are staunchly opposed to COVID-19 vaccines.

The others, hopefully, can be reached by answering their questions about the vaccines and making it as easy as possible to get vaccinated by bringing the shots to them, she said.

“This is the time for us to say, ‘We can answer your questions,’” said Henry.

The province is not currently considering punitive measures, like mandating businesses to require proof of immunization for service, to encourage people to be vaccinated.

But Henry said businesses and events are within their rights to require vaccines for entry or separate vaccinated and unvaccinated customers.

“It is a choice not to get vaccinated, but there are consequences,” said Henry.

Health-care workers who choose not to be vaccinated will be required to mask and present negative COVID-19 tests, she added, and potentially barred from working in certain units.

“I have very limited patience for people in health care who are not vaccinated,” said Henry. “There will be consequences for that decision.”

Henry and Health Minister Adrian Dix noted that with increased vaccination and the province’s low and stable hospitalization rates, it is unlikely B.C. will see more restrictions or the mask mandate reinstated. The U.S. Centers for Disease Control recommended a return to mask mandates today.

“COVID is going to be with us for a while,” said Dix. “The pandemic, we hope, will not.”

Moira Wyton, Local Journalism Initiative Reporter, The Tyee

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COVID-19 in B.C.: New immunization campaign; cases among and measures against unvaccinated people; and more – The Georgia Straight

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With B.C. nearing the end of the fourth and final phase of its COVID-19 immunization plan, health officials provided an update on where the province is at with vaccinations and what it will do next.

At a news conference in Vancouver today (July 27), B.C. immunization rollout team executive lead Penny Ballem, B.C. Health Minister Adrian Dix, and provincial health officer Dr. Bonnie Henry provided updates about vaccination data and announced the launch of a new campaign that reflects a shift from mass vaccinations to reaching those who haven’t yet received vaccinations.

“With more than 80 percent of eligible people in B.C. vaccinated with their first dose and more than 60 percent fully vaccinated, we have made tremendous progress in our vaccine rollout,” Dix said.

Over 6.5 million COVID-19 vaccine doses have now been administered in B.C. As of July 26, 3,736,651 people (80.6 percent) who are 12 years and above have received their first dose and 2,840,194 (61.3 percent) have received their second dose.

While Dix, Henry, and Ballem thanked everyone who has received their vaccinations, and those working in the immunization program, all note that more vaccinations still need to be done.

B.C. provincial health officer Dr. Bonnie Henry, with B.C. immunization rollout team executive lead Penny Ballem
Province of British Columbia

“We now know that the majority of our new cases, some of which have increased in the last little while, are among people who have not yet received their vaccine,” Henry said.

According to data from the B.C. Centre of Disease Control (BCCDC), there were 1,210 COVID-19 cases among unvaccinated people from June 15 to July 15 while there were 499 cases among people who had only received one dose.

In comparison, there were 65 cases, or less than five percent of COVID-19 cases, from June 15 to July 15 were among fully vaccinated people.

During that same time period, Henry pointed out that there has been a “high rate” of unvaccinated individuals—137 out of 176 hospitalized cases, or 78 percent—who have been hospitalized in B.C. with COVID-19, and an additional 18 percent of those who have only received their first dose.

Henry also cited her colleagues in the U.S. who are seeing a “new pandemic” among those who are unvaccinated.

Ballem presented data about unvaccinated population numbers by regional health authorities.

In total, there are 906,722 British Columbians, or 19.6 percent, who have not yet been vaccinated.

The largest number of unvaccinated individuals is in Fraser Health 315,748—but that represents 18.4 percent of the population in that region.

Northern Health has the highest percentage of unvaccinated people, with 84,573 individuals, or 32.5 percent of its population.

Interior Health follows Fraser Health with 199,159 unvaccinated individuals, but follows Northern Health percentage-wise with 26.2 percent of its population unvaccinated.

Vancouver Coastal Health has 141,169 unvaccinated individuals, or 18.1 percent, which is about the same percentage as Fraser Health. 

Island Health has 166,123 unvaccinated individuals but that represents the lowest percentage in the province at 14.8 percent of its population.

Henry explained that there are vaccination challenges in Northern and Interior Health where there are small communities that are physically distant from each other, have lack of access to vaccines, or have been affected by wildfires.

B.C. immunization rollout team executive lead Penny Ballem, provincial health officer Dr. Bonnie Henry, and Health Minister Adrian Dix
Province of British Columbia

When asked if the province will take any punitive measures against those who are unvaccinated, Dix said that although vaccinations aren’t and won’t be mandatory in B.C., but “measures will be taken” to protect people from those who are unvaccinated, such as in longterm care facilities.

Henry explained that based on a survey, people have expressed a range of reasons why they remain unvaccinated, ranging from inconvenience of accessing vaccinations to lack of confidence in vaccines.

“It is choice to be immunized, but there are consequences for people who are not immunized,” Henry said, “and that’s going to be more important for us as we head into the fall, as we know that this virus will increase, as we know that we’ll likely see other respiratory viruses, and—incredibly important from my perspective—is protecting those people who we know may not mount as good an immune response from vaccine.”

Of the latter group, Henry said that includes seniors and elders, and those in longterm care and the healthcare sector.

As previously announced, Henry said that those working in healthcare who choose to remain unvaccinated will need to take additional prevention and control measures, such as wearing masks and regular testing, and that they won’t be permitted to work in specific settings.

“I have very little patience for people who are not vaccinated in healthcare,” Henry said, with a self-effacing chuckle.

Henry said that the number of anti-vaxxers in the province remains low, at about one to two percent of the population, which she said is a “very small percent” but that they are very organized and vocal.

Dix cited the example of measles immunizations amongst students in 2019, and that if there is an outbreak of measles, those who aren’t immunized will be excluded from school. Accordingly, he said that there will be similar consequences for not being immunized for COVID-19.

However, he also pointed out how young people responded to the measles immunization program and that he expects that those aged 18 to 24 will be more immunized than any other age group because of their willingness to participate in the program.

Citing the examples of recent clusters connected to nightclubs and gatherings in indoor settings with poor ventilation such as weddings or funerals, Henry said she is in support of businesses opting to require anyone to only admit people who are vaccinated.

“That gives people the level of comfort that they are in a safer environment,” she said. She added that if transmission occurs at a business, health officials will temporarily shut down the business.

The Vax for B.C. campaign, which will be aimed at reaching people who still need vaccinations, begins today and will continue throughout August, and will involve community events, vaccination vehicles, and mobile clinics across the province. More focus will be placed on local public health clinics, community outreach efforts, mobile programs, and pop-up clinics.

These events will permit all eligible individuals to drop in for vaccinations without appointments (although registration and booking with the provincial Get Vaccinated system is still encouraged).

The first provincewide Walk-in Wednesday will be held on August 4, which will make 20,000 doses available for drop-ins for anyone who is 12 years and above and is eligible for their first or second doses.  

A complete list of Vax for B.C. events throughout the province is available online

For today’s B.C. COVID-19 update, see this article

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