Pandemic 2020

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UK becomes first country to approve updated Moderna vaccine targeting omicron
The United Kingdom on Monday became the first country to approve an updated COVID-19 vaccine from Moderna targeting the omicron variant as well as the original strain of the virus.

The move is a step toward a booster campaign that could provide people with better protection against the variants that are currently circulating.

“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives,” said June Raine, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency. “What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.”

The United States is also working on updated vaccines for a possible fall booster campaign, though the shots might be slightly different. The vaccine approved by the UK targets the first version of the omicron variant, known as BA.1, while the U.S. Food and Drug Administration has instructed vaccine makers to target the more recent subvariants of omicron, known as BA.4 and BA.5.

The UK regulator on Monday said the updated Moderna vaccine was shown to provide a “strong immune response” against BA.1 as well as BA.4 and BA.5.

“Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified,” it added.

Experts stress that it is still important for people to get booster shots of the original vaccine now if they have not already, given that it still provides important protection against severe disease and hospitalization. The updated vaccine targeting the newest variants, however, is expected to provide even better protection and adapt to the virus’s evolution.
 

DIY-HP-LED

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Trial compared the effect of ivermectin, fluvoxamine, and metformin in randomized double-blinded placebo- controlled trial.

Scientists have found that metformin, a commonly prescribed diabetes medication, lowers the odds of emergency department visits, hospitalizations, or death due to COVID-19 by over 40 percent; and over 50 percent if prescribed early in onset of symptoms. The study, which was published on August 18 in the New England Journal of Medicine, also found no positive effect from treatment with either ivermectin or low-dose fluvoxamine. The research was led by the University of Minnesota Medical School and School of Public Health.
 

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Pfizer submits application for updated COVID-19 vaccine booster to FDA
Pfizer said Monday that it has submitted its application to the Food and Drug Administration (FDA) for an updated COVID-19 vaccine targeting the omicron subvariant currently circulating.
The application comes ahead of a fall booster shot campaign. Assuming the FDA signs off, the shots are expected to begin in September.

The application, per instructions previously given by FDA, is for a “bivalent” vaccine that targets the BA.4 and BA.5 subvariants of omicron currently circulating, as well as the original form of the virus.
The vaccine is designed to be more effective against the current form of the virus, given there has been significant evolution. In addition, protection from the initial shots wanes over time.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Albert Bourla, Pfizer’s CEO, said in a statement.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” he added.
The application is for everyone 12 years of age and older.

“The vaccines that are coming in a few short weeks are specifically designed for the virus that’s out there, and I believe it’s going to be available and every American over the age of 12 will be eligible,” White House COVID-19 response coordinator Ashish Jha said last week on “NBC Nightly News.”

Pfizer said the first doses are available to ship immediately pending authorization from the FDA.
The company said that, following FDA guidance, it had submitted clinical data from a slightly different vaccine, targeting the BA.1 strain of omicron, as well as more preliminary data from the BA.4/BA.5 vaccine itself.

The BA.1 vaccine was “was well-tolerated with a favorable safety profile,” Pfizer said.

It remains unclear how many people will get the new boosters, despite the potential for a surge of COVID-19 over the fall and winter, given that uptake for the first booster shot has been lagging.
Only about half of people who got the first two shots received the first booster shot, according to Centers for Disease Control and Prevention data.
 

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FDA clears updated COVID-19 vaccines ahead of fall booster campaign
The Food and Drug Administration (FDA) on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron.

The move comes ahead of a fall campaign to give Americans booster shots, which is expected to launch in the coming days.

The move marks the first time the vaccines have been updated since the first shots were cleared at the end of 2020, and the updated shots are designed to catch up to evolutions in the virus.

The shots from Pfizer and Moderna target the omicron subvariants BA.4 and BA.5, as well as the original virus.

The shots can begin going into arms once the final step in the process, a Centers for Disease Control and Prevention committee, clears them, which is expected to occur on Thursday.

A major question, though, is how many people will actually want the new shots, given that uptake for the existing booster shots has lagged.

Only about half of people who got the first two shots received the initial booster dose.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert Califf. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

Seeking to keep up with the ever-evolving virus, the FDA did not wait for the time-consuming process of going through full clinical trials on this tweaked vaccine. But it noted that it is highly confident that the vaccines are safe and effective. The agency pointed to the millions of doses of the original vaccines that have been given, as well as data from another version of the updated vaccine, along with preliminary data on this one.

Peter Marks, a top FDA vaccine official, compared the process to the annual updates to the flu vaccine that seek to adapt to the changes in that virus.

“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks said.

The updated Moderna vaccine is cleared for people 18 and older, and the Pfizer vaccine for people 12 and older.

For both, people are eligible for the booster shot of the updated vaccine if it has been at least two months since their last shot.

Come on Canada.
 

DIY-HP-LED

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FDA Approves Updated Pfizer, Moderna Booster Shots Targeting BA.5 Subvariant
1,269 views Aug 31, 2022 The Food and Drug Administration has authorized the updated versions of Pfizer-BioNTech’s and Moderna’s Covid booster shots. These vaccines will specifically target the BA.5 omicron subvariant but need to be approved by the Centers for Disease Control and Prevention before administering begins.
 

CunningCanuk

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FDA clears updated COVID-19 vaccines ahead of fall booster campaign
The Food and Drug Administration (FDA) on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron.

The move comes ahead of a fall campaign to give Americans booster shots, which is expected to launch in the coming days.

The move marks the first time the vaccines have been updated since the first shots were cleared at the end of 2020, and the updated shots are designed to catch up to evolutions in the virus.

The shots from Pfizer and Moderna target the omicron subvariants BA.4 and BA.5, as well as the original virus.

The shots can begin going into arms once the final step in the process, a Centers for Disease Control and Prevention committee, clears them, which is expected to occur on Thursday.

A major question, though, is how many people will actually want the new shots, given that uptake for the existing booster shots has lagged.

Only about half of people who got the first two shots received the initial booster dose.

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert Califf. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

Seeking to keep up with the ever-evolving virus, the FDA did not wait for the time-consuming process of going through full clinical trials on this tweaked vaccine. But it noted that it is highly confident that the vaccines are safe and effective. The agency pointed to the millions of doses of the original vaccines that have been given, as well as data from another version of the updated vaccine, along with preliminary data on this one.

Peter Marks, a top FDA vaccine official, compared the process to the annual updates to the flu vaccine that seek to adapt to the changes in that virus.

“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks said.

The updated Moderna vaccine is cleared for people 18 and older, and the Pfizer vaccine for people 12 and older.

For both, people are eligible for the booster shot of the updated vaccine if it has been at least two months since their last shot.

Come on Canada.
Health Canada set to announce approval of Moderna vaccine for Omicron variant: sources

 

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Health Canada approves Moderna’s Omicron booster vaccine
Health Canada approved a new COVID-19 vaccine from Moderna Thursday that targets both the original strain of the novel coronavirus and the specific Omicron variant.

The new shots approved by Health Canada, called bivalent vaccines, are designed to recognize specific mutations in the spike protein of the Omicron BA.1 subvariant.

Shipments of the vaccine are expected to arrive in the next few days, and there will be enough supply for all Canadians 18 and older to get a dose this fall and winter, officials said.

In a decision posted on Health Canada’s website, the regulator says data show the new vaccine induces a similar immune response to the original strain of the COVID-19 virus and significantly higher responses to the Omicron BA. 1 variant, when compared with the earlier version of the Moderna vaccine.

The United Kingdom approved Moderna’s new vaccine two weeks ago, and the United States Food and Drug Administration gave Moderna and Pfizer-BioNTech’s Omicron-fighting shots the green light earlier this week.

The version approved in the U.S. targets newer and more prevalent strains of the Omicron variant than the one submitted for approval in Canada.

“While the vaccine was designed to more specifically target the Omicron BA.1 subvariant, we know that this vaccine also generates a good immune response against Omicron BA.4 and BA.5 subvariants that have more recently emerged,” Sharma said.

The BA.5 subvariant currently represents approximately 82 per cent of the virus circulating in Canada, Public Health Agency of Canada data show. BA.4 makes up nearly 12 per cent and BA.1 represents only 0.1 per cent.

Health Canada has specifically asked Moderna and Pfizer-BioNTech to request approval for vaccines that target the BA.4 and BA.5 subvariants, and is expecting applications from both companies within the next few weeks.

While more than 90 per cent of adults have received two doses of an approved COVID-19 vaccine in Canada, only about 59 per cent have opted for a booster dose as of Aug. 14, Public Health Agency of Canada data show.
 

DIY-HP-LED

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I'm going for the forth shot this fall and I'd like the latest iteration of the vaccine to keep up with this evolving pestilence, but I suppose take what you can get! I see few masks out in public, I wear one in the store etc, the hospitals are still full of people with covid, many have been vaxxed, but far fewer are dying or seriously ill.
 

CunningCanuk

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I'm going for the forth shot this fall and I'd like the latest iteration of the vaccine to keep up with this evolving pestilence, but I suppose take what you can get! I see few masks out in public, I wear one in the store etc, the hospitals are still full of people with covid, many have been vaxxed, but far fewer are dying or seriously ill.
I got my fourth shot in May. No masks being worn around here either though I’m not aware of the local hospitals being full of people with Covid.
 
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