Covid 19 Vaccine Everything You Need To Know About Omicron Boosters

Here’s everything you need to know about bipolar amplifiers. These new bivalent vaccines carry instructions to help our cells defend against two strains of the virus that causes Covid-19. The shots direct cells to make antibodies that bind to certain parts of the spike proteins from both the original SARS-CoV-2 virus strain and the BA.4 and BA.5 Omicron subvariants, which share the same spike. BA.4 and BA.5 are the predominant variants in the United States, causing an average of 91,000 new infections each day.
“These are vaccines that are designed, manufactured and delivered identically to the Covid mRNA vaccines that most of us already have,” said Dr. Gregory Poland, who leads the vaccine research team at the Mayo Clinic in Rochester, Minnesota. “In a sense, you’ve just changed the blueprints.” However, having twice the plans doesn’t mean you’re getting twice the dose of active ingredients. “The total mRNA content — the business part of the vaccine — that drives the immune response is the same amount,” said Dr. William Gruber, senior vice president of vaccine research and development at Pfizer, which is one of the updated vaccines. Pfizer’s booster is a 30 microgram dose containing 15 micrograms of mRNA against the parent strain and 15 micrograms against the BA.4 and BA.5 variants. It is approved for people 12 years of age.
The company is also updating its shots for children ages 5 to 11, and will seek FDA approval of these updated boosters in early October. Works with FDA to update vaccines for children ages 6 months to 4 years. Moderna’s bivalent booster is a 50-microgram dose, with 25 micrograms of mRNA designed to fight the ancestral strain of the coronavirus and 25 micrograms of mRNA designed to fight the BA.4 and BA.5 variants. It is authorized for persons 18 years of age and older.

Where and when can I get an updated Covid-19 booster?

The government has already taken orders for these vaccines, and now that the FDA has approved them, millions of doses will be shipped to tens of thousands of locations across the country. These include community health centres, health departments and pharmacies. As with previous Covid-19 vaccines, these vaccines will be available free of charge. But they may be some of the last Covid-19 freebies from the government, which has said it is set to start marketing treatments and vaccines this autumn. Pfizer says it has the ability to ship up to 15 million doses by September 9. The panel of experts that advises the U.S. Centers for Disease Control and Prevention on vaccine recommendations reviewed the science behind the vaccines Thursday and voted to recommend them. Then CDC Director Dr. Rochelle Walensky, signed off, which means people can start taking the shots right away. “What I expect is, after the CDC action, you’re going to start to see some places start giving some shots over the weekend, but very relatively few because [of the] Labor Day weekend. And my expectation is over the next week, or certainly in the next 10 days, you’ll start to see these bivalent vaccines become widely available across the country,” said Dr. he told CNN. The Biden administration expects appointment availability to increase in the first few days, with widespread availability in a few weeks. People will be able to find locations on Vaccines.gov. The administration is also preparing to launch a campaign urging Americans to get their annual flu shot along with an updated Covid-19 booster. Research on this approach shows that it is safe. Updated Covid-19 vaccinations will be the only game in town in terms of boosters, at least for those aged 12 and over. The FDA says the older boosters are no longer authorized for this age group, but will still be available as boosters for children ages 5 to 11.

How do we know the updated Covid-19 vaccines work?

These are the first Covid-19 vaccines to be approved for use in humans after being tested only in mice. This is roughly the same process that is followed each year when the annual flu shots are updated. The FDA has allowed companies to submit data from animal testing in order to expedite these downloads to the public. Human studies are ongoing, according to Pfizer’s Gruber. Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said he expects it will be a month or two before human data are available. Officials say the urgency with these boosters is warranted since the fall, when Covid-19 is still circulating at high levels and the flu is expected to return. But the decision to rely on animal studies has caused some controversy. Some vaccine experts believe that animal studies do not provide sufficient evidence for these vaccines at this stage of the pandemic. “You’re asking people to take a new product that has no data,” Dr. Paul Offit, who directs the vaccine education center at the Children’s Hospital of Philadelphia. “Mice data insufficient to launch 100-plus billion-dose effort.” Offit says it makes sense to use data from animal studies for updates to annual flu shots because we’ve used these vaccines for decades and understand what biomarkers to look for when measuring whether they’re working. These so-called protective associations are not as well understood for Covid-19 vaccines.
It’s not just the shots that are different, Poland said. At this point in the pandemic, our immune systems are too. Almost all Americans have been infected with the coronavirus, vaccinated, or both. Some people have had four or five doses of the vaccine. “If you say to me, ‘can you assure me that getting dose five or dose six of this new vaccine on top of getting these previous doses is perfectly safe?’ I’d say ‘no, I can’t.’ We’re extrapolating. And I think we should be clear about that,” Poland said. FDA officials point out that animal studies weren’t the only data they looked at in making their decision. They looked at two other lines of evidence.
The first is vaccine history. The same basic vaccines have now been given to hundreds of millions of people around the world. They have proven highly effective in preventing serious illness and death from Covid-19. The risks associated with mRNA vaccination are very, very low.
The second line of evidence comes from bivalent vaccines that may soon be used in Europe.
Earlier this year, Pfizer and Moderna presented an independent panel of experts advising the FDA with data on a bivalent vaccine designed to target Omicron’s original strain, BA.1. These data showed that the vaccines boosted antibody responses and were well tolerated. The UK has approved these vaccines, but they will not be available in the US. The BA.1 strain is no longer available, and the FDA has asked manufacturers to update their US downloads to include BA.4 and BA.5 instead.
Marks said in a briefing Wednesday that some evidence suggests that the BA.4 and BA.5 strains generate a stronger immune response than BA.1, which is another reason officials wanted to include them in the updated shots. FDA Commissioner Dr. Robert Califf said he understands people may want to know more, but he is confident these vaccines are safe and effective. “It’s fair for people to raise questions. But this is really the best consensus we have among experts that this is the best way to go… It’s just painful to see people die needlessly when there’s a free treatment that will prevent death told them. “I’ll be in the front line at the pharmacy to get my shot,” said Califf, who turns 71 next month. “I am very sure of it.” In the past, vaccine trials for specific variants have had inconclusive results. It is difficult to know what effect these bivalent vaccines might have.
In a recent preprint study, published before peer review, scientists tried to assess this with a meta-analysis, or review of studies. They gathered estimates of antibody levels after booster doses against the ancestral strains, as well as against specific variants, and tried to use those levels to predict how well the shots would work. They found that people get the most benefits from reinforcement, period. A booster against the ancestral strain of the virus that causes Covid-19 increased neutralizing antibodies 11-fold. The scientists calculated that this would increase a person’s protection against symptomatic infection over the next six months from 50% to 86.5%.
Variant-specific amps performed slightly better, but the difference wasn’t dramatic. After these shots, protection against symptomatic infection over the next six months rose to 90.2%, just a 4.6% increase.

Are Covid-19 boosters safe?

A recent review of adverse events following mRNA booster vaccinations in adults in the United States found that adverse events were less common after booster doses than after second doses of the vaccine, and most were mild. About 1 in 8 adults reported headache, fever, or pain after a booster. In children and adolescents, the most commonly reported side effects after boosters were injection site pain, fatigue, headache, and muscle aches. Very rarely, mRNA vaccines can cause myocarditis, or swelling in or around the heart. After more than 80 million booster doses were given in the United States, government safety surveillance systems received 37 verifiable reports of myocarditis. Most of these were in men. The highest rates of myocarditis in adults were in younger men — ages 18 to 24. For every million booster doses given to men this age, the CDC expects about that many will have myocarditis. For teenagers, the rate is slightly higher but still extremely low: about 11 cases of myocarditis for every million doses. Marks said that to minimize that risk, officials are directing that…

title: “Covid 19 Vaccine Everything You Need To Know About Omicron Boosters Klmat” ShowToc: true date: “2022-11-28” author: “Raymond Brooks”

Here’s everything you need to know about bipolar amplifiers. These new bivalent vaccines carry instructions to help our cells defend against two strains of the virus that causes Covid-19. The shots direct cells to make antibodies that bind to certain parts of the spike proteins from both the original SARS-CoV-2 virus strain and the BA.4 and BA.5 Omicron subvariants, which share the same spike. BA.4 and BA.5 are the predominant variants in the United States, causing an average of 91,000 new infections each day.
“These are vaccines that are designed, manufactured and delivered identically to the Covid mRNA vaccines that most of us already have,” said Dr. Gregory Poland, who leads the vaccine research team at the Mayo Clinic in Rochester, Minnesota. “In a sense, you’ve just changed the blueprints.” However, having twice the plans doesn’t mean you’re getting twice the dose of active ingredients. “The total mRNA content — the business part of the vaccine — that drives the immune response is the same amount,” said Dr. William Gruber, senior vice president of vaccine research and development at Pfizer, which is one of the updated vaccines. Pfizer’s booster is a 30 microgram dose containing 15 micrograms of mRNA against the parent strain and 15 micrograms against the BA.4 and BA.5 variants. It is approved for people 12 years of age.
The company is also updating its shots for children ages 5 to 11, and will seek FDA approval of these updated boosters in early October. Works with FDA to update vaccines for children ages 6 months to 4 years. Moderna’s bivalent booster is a 50-microgram dose, with 25 micrograms of mRNA designed to fight the ancestral strain of the coronavirus and 25 micrograms of mRNA designed to fight the BA.4 and BA.5 variants. It is authorized for persons 18 years of age and older.

Where and when can I get an updated Covid-19 booster?

The government has already taken orders for these vaccines, and now that the FDA has approved them, millions of doses will be shipped to tens of thousands of locations across the country. These include community health centres, health departments and pharmacies. As with previous Covid-19 vaccines, these vaccines will be available free of charge. But they may be some of the last Covid-19 freebies from the government, which has said it is set to start marketing treatments and vaccines this autumn. Pfizer says it has the ability to ship up to 15 million doses by September 9. The panel of experts that advises the U.S. Centers for Disease Control and Prevention on vaccine recommendations reviewed the science behind the vaccines Thursday and voted to recommend them. Then CDC Director Dr. Rochelle Walensky, signed off, which means people can start taking the shots right away. “What I expect is, after the CDC action, you’re going to start to see some places start giving some shots over the weekend, but very relatively few because [of the] Labor Day weekend. And my expectation is over the next week, or certainly in the next 10 days, you’ll start to see these bivalent vaccines become widely available across the country,” said Dr. he told CNN. The Biden administration expects appointment availability to increase in the first few days, with widespread availability in a few weeks. People will be able to find locations on Vaccines.gov. The administration is also preparing to launch a campaign urging Americans to get their annual flu shot along with an updated Covid-19 booster. Research on this approach shows that it is safe. Updated Covid-19 vaccinations will be the only game in town in terms of boosters, at least for those aged 12 and over. The FDA says the older boosters are no longer authorized for this age group, but will still be available as boosters for children ages 5 to 11.

How do we know the updated Covid-19 vaccines work?

These are the first Covid-19 vaccines to be approved for use in humans after being tested only in mice. This is roughly the same process that is followed each year when the annual flu shots are updated. The FDA has allowed companies to submit data from animal testing in order to expedite these downloads to the public. Human studies are ongoing, according to Pfizer’s Gruber. Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said he expects it will be a month or two before human data are available. Officials say the urgency with these boosters is warranted since the fall, when Covid-19 is still circulating at high levels and the flu is expected to return. But the decision to rely on animal studies has caused some controversy. Some vaccine experts believe that animal studies do not provide sufficient evidence for these vaccines at this stage of the pandemic. “You’re asking people to take a new product that has no data,” Dr. Paul Offit, who directs the vaccine education center at the Children’s Hospital of Philadelphia. “Mice data insufficient to launch 100-plus billion-dose effort.” Offit says it makes sense to use data from animal studies for updates to annual flu shots because we’ve used these vaccines for decades and understand what biomarkers to look for when measuring whether they’re working. These so-called protective associations are not as well understood for Covid-19 vaccines.
It’s not just the shots that are different, Poland said. At this point in the pandemic, our immune systems are too. Almost all Americans have been infected with the coronavirus, vaccinated, or both. Some people have had four or five doses of the vaccine. “If you say to me, ‘can you assure me that getting dose five or dose six of this new vaccine on top of getting these previous doses is perfectly safe?’ I’d say ‘no, I can’t.’ We’re extrapolating. And I think we should be clear about that,” Poland said. FDA officials point out that animal studies weren’t the only data they looked at in making their decision. They looked at two other lines of evidence.
The first is vaccine history. The same basic vaccines have now been given to hundreds of millions of people around the world. They have proven highly effective in preventing serious illness and death from Covid-19. The risks associated with mRNA vaccination are very, very low.
The second line of evidence comes from bivalent vaccines that may soon be used in Europe.
Earlier this year, Pfizer and Moderna presented an independent panel of experts advising the FDA with data on a bivalent vaccine designed to target Omicron’s original strain, BA.1. These data showed that the vaccines boosted antibody responses and were well tolerated. The UK has approved these vaccines, but they will not be available in the US. The BA.1 strain is no longer available, and the FDA has asked manufacturers to update their US downloads to include BA.4 and BA.5 instead.
Marks said in a briefing Wednesday that some evidence suggests that the BA.4 and BA.5 strains generate a stronger immune response than BA.1, which is another reason officials wanted to include them in the updated shots. FDA Commissioner Dr. Robert Califf said he understands people may want to know more, but he is confident these vaccines are safe and effective. “It’s fair for people to raise questions. But this is really the best consensus we have among experts that this is the best way to go… It’s just painful to see people die needlessly when there’s a free treatment that will prevent death told them. “I’ll be in the front line at the pharmacy to get my shot,” said Califf, who turns 71 next month. “I am very sure of it.” In the past, vaccine trials for specific variants have had inconclusive results. It is difficult to know what effect these bivalent vaccines might have.
In a recent preprint study, published before peer review, scientists tried to assess this with a meta-analysis, or review of studies. They gathered estimates of antibody levels after booster doses against the ancestral strains, as well as against specific variants, and tried to use those levels to predict how well the shots would work. They found that people get the most benefits from reinforcement, period. A booster against the ancestral strain of the virus that causes Covid-19 increased neutralizing antibodies 11-fold. The scientists calculated that this would increase a person’s protection against symptomatic infection over the next six months from 50% to 86.5%.
Variant-specific amps performed slightly better, but the difference wasn’t dramatic. After these shots, protection against symptomatic infection over the next six months rose to 90.2%, just a 4.6% increase.

Are Covid-19 boosters safe?

A recent review of adverse events following mRNA booster vaccinations in adults in the United States found that adverse events were less common after booster doses than after second doses of the vaccine, and most were mild. About 1 in 8 adults reported headache, fever, or pain after a booster. In children and adolescents, the most commonly reported side effects after boosters were injection site pain, fatigue, headache, and muscle aches. Very rarely, mRNA vaccines can cause myocarditis, or swelling in or around the heart. After more than 80 million booster doses were given in the United States, government safety surveillance systems received 37 verifiable reports of myocarditis. Most of these were in men. The highest rates of myocarditis in adults were in younger men — ages 18 to 24. For every million booster doses given to men this age, the CDC expects about that many will have myocarditis. For teenagers, the rate is slightly higher but still extremely low: about 11 cases of myocarditis for every million doses. Marks said that to minimize that risk, officials are directing that…

title: “Covid 19 Vaccine Everything You Need To Know About Omicron Boosters Klmat” ShowToc: true date: “2022-10-30” author: “Shaina Toland”

Here’s everything you need to know about bipolar amplifiers. These new bivalent vaccines carry instructions to help our cells defend against two strains of the virus that causes Covid-19. The shots direct cells to make antibodies that bind to certain parts of the spike proteins from both the original SARS-CoV-2 virus strain and the BA.4 and BA.5 Omicron subvariants, which share the same spike. BA.4 and BA.5 are the predominant variants in the United States, causing an average of 91,000 new infections each day.
“These are vaccines that are designed, manufactured and delivered identically to the Covid mRNA vaccines that most of us already have,” said Dr. Gregory Poland, who leads the vaccine research team at the Mayo Clinic in Rochester, Minnesota. “In a sense, you’ve just changed the blueprints.” However, having twice the plans doesn’t mean you’re getting twice the dose of active ingredients. “The total mRNA content — the business part of the vaccine — that drives the immune response is the same amount,” said Dr. William Gruber, senior vice president of vaccine research and development at Pfizer, which is one of the updated vaccines. Pfizer’s booster is a 30 microgram dose containing 15 micrograms of mRNA against the parent strain and 15 micrograms against the BA.4 and BA.5 variants. It is approved for people 12 years of age.
The company is also updating its shots for children ages 5 to 11, and will seek FDA approval of these updated boosters in early October. Works with FDA to update vaccines for children ages 6 months to 4 years. Moderna’s bivalent booster is a 50-microgram dose, with 25 micrograms of mRNA designed to fight the ancestral strain of the coronavirus and 25 micrograms of mRNA designed to fight the BA.4 and BA.5 variants. It is authorized for persons 18 years of age and older.

Where and when can I get an updated Covid-19 booster?

The government has already taken orders for these vaccines, and now that the FDA has approved them, millions of doses will be shipped to tens of thousands of locations across the country. These include community health centres, health departments and pharmacies. As with previous Covid-19 vaccines, these vaccines will be available free of charge. But they may be some of the last Covid-19 freebies from the government, which has said it is set to start marketing treatments and vaccines this autumn. Pfizer says it has the ability to ship up to 15 million doses by September 9. The panel of experts that advises the U.S. Centers for Disease Control and Prevention on vaccine recommendations reviewed the science behind the vaccines Thursday and voted to recommend them. Then CDC Director Dr. Rochelle Walensky, signed off, which means people can start taking the shots right away. “What I expect is, after the CDC action, you’re going to start to see some places start giving some shots over the weekend, but very relatively few because [of the] Labor Day weekend. And my expectation is over the next week, or certainly in the next 10 days, you’ll start to see these bivalent vaccines become widely available across the country,” said Dr. he told CNN. The Biden administration expects appointment availability to increase in the first few days, with widespread availability in a few weeks. People will be able to find locations on Vaccines.gov. The administration is also preparing to launch a campaign urging Americans to get their annual flu shot along with an updated Covid-19 booster. Research on this approach shows that it is safe. Updated Covid-19 vaccinations will be the only game in town in terms of boosters, at least for those aged 12 and over. The FDA says the older boosters are no longer authorized for this age group, but will still be available as boosters for children ages 5 to 11.

How do we know the updated Covid-19 vaccines work?

These are the first Covid-19 vaccines to be approved for use in humans after being tested only in mice. This is roughly the same process that is followed each year when the annual flu shots are updated. The FDA has allowed companies to submit data from animal testing in order to expedite these downloads to the public. Human studies are ongoing, according to Pfizer’s Gruber. Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said he expects it will be a month or two before human data are available. Officials say the urgency with these boosters is warranted since the fall, when Covid-19 is still circulating at high levels and the flu is expected to return. But the decision to rely on animal studies has caused some controversy. Some vaccine experts believe that animal studies do not provide sufficient evidence for these vaccines at this stage of the pandemic. “You’re asking people to take a new product that has no data,” Dr. Paul Offit, who directs the vaccine education center at the Children’s Hospital of Philadelphia. “Mice data insufficient to launch 100-plus billion-dose effort.” Offit says it makes sense to use data from animal studies for updates to annual flu shots because we’ve used these vaccines for decades and understand what biomarkers to look for when measuring whether they’re working. These so-called protective associations are not as well understood for Covid-19 vaccines.
It’s not just the shots that are different, Poland said. At this point in the pandemic, our immune systems are too. Almost all Americans have been infected with the coronavirus, vaccinated, or both. Some people have had four or five doses of the vaccine. “If you say to me, ‘can you assure me that getting dose five or dose six of this new vaccine on top of getting these previous doses is perfectly safe?’ I’d say ‘no, I can’t.’ We’re extrapolating. And I think we should be clear about that,” Poland said. FDA officials point out that animal studies weren’t the only data they looked at in making their decision. They looked at two other lines of evidence.
The first is vaccine history. The same basic vaccines have now been given to hundreds of millions of people around the world. They have proven highly effective in preventing serious illness and death from Covid-19. The risks associated with mRNA vaccination are very, very low.
The second line of evidence comes from bivalent vaccines that may soon be used in Europe.
Earlier this year, Pfizer and Moderna presented an independent panel of experts advising the FDA with data on a bivalent vaccine designed to target Omicron’s original strain, BA.1. These data showed that the vaccines boosted antibody responses and were well tolerated. The UK has approved these vaccines, but they will not be available in the US. The BA.1 strain is no longer available, and the FDA has asked manufacturers to update their US downloads to include BA.4 and BA.5 instead.
Marks said in a briefing Wednesday that some evidence suggests that the BA.4 and BA.5 strains generate a stronger immune response than BA.1, which is another reason officials wanted to include them in the updated shots. FDA Commissioner Dr. Robert Califf said he understands people may want to know more, but he is confident these vaccines are safe and effective. “It’s fair for people to raise questions. But this is really the best consensus we have among experts that this is the best way to go… It’s just painful to see people die needlessly when there’s a free treatment that will prevent death told them. “I’ll be in the front line at the pharmacy to get my shot,” said Califf, who turns 71 next month. “I am very sure of it.” In the past, vaccine trials for specific variants have had inconclusive results. It is difficult to know what effect these bivalent vaccines might have.
In a recent preprint study, published before peer review, scientists tried to assess this with a meta-analysis, or review of studies. They gathered estimates of antibody levels after booster doses against the ancestral strains, as well as against specific variants, and tried to use those levels to predict how well the shots would work. They found that people get the most benefits from reinforcement, period. A booster against the ancestral strain of the virus that causes Covid-19 increased neutralizing antibodies 11-fold. The scientists calculated that this would increase a person’s protection against symptomatic infection over the next six months from 50% to 86.5%.
Variant-specific amps performed slightly better, but the difference wasn’t dramatic. After these shots, protection against symptomatic infection over the next six months rose to 90.2%, just a 4.6% increase.

Are Covid-19 boosters safe?

A recent review of adverse events following mRNA booster vaccinations in adults in the United States found that adverse events were less common after booster doses than after second doses of the vaccine, and most were mild. About 1 in 8 adults reported headache, fever, or pain after a booster. In children and adolescents, the most commonly reported side effects after boosters were injection site pain, fatigue, headache, and muscle aches. Very rarely, mRNA vaccines can cause myocarditis, or swelling in or around the heart. After more than 80 million booster doses were given in the United States, government safety surveillance systems received 37 verifiable reports of myocarditis. Most of these were in men. The highest rates of myocarditis in adults were in younger men — ages 18 to 24. For every million booster doses given to men this age, the CDC expects about that many will have myocarditis. For teenagers, the rate is slightly higher but still extremely low: about 11 cases of myocarditis for every million doses. Marks said that to minimize that risk, officials are directing that…

title: “Covid 19 Vaccine Everything You Need To Know About Omicron Boosters Klmat” ShowToc: true date: “2022-11-14” author: “Laura Ybarra”

Here’s everything you need to know about bipolar amplifiers. These new bivalent vaccines carry instructions to help our cells defend against two strains of the virus that causes Covid-19. The shots direct cells to make antibodies that bind to certain parts of the spike proteins from both the original SARS-CoV-2 virus strain and the BA.4 and BA.5 Omicron subvariants, which share the same spike. BA.4 and BA.5 are the predominant variants in the United States, causing an average of 91,000 new infections each day.
“These are vaccines that are designed, manufactured and delivered identically to the Covid mRNA vaccines that most of us already have,” said Dr. Gregory Poland, who leads the vaccine research team at the Mayo Clinic in Rochester, Minnesota. “In a sense, you’ve just changed the blueprints.” However, having twice the plans doesn’t mean you’re getting twice the dose of active ingredients. “The total mRNA content — the business part of the vaccine — that drives the immune response is the same amount,” said Dr. William Gruber, senior vice president of vaccine research and development at Pfizer, which is one of the updated vaccines. Pfizer’s booster is a 30 microgram dose containing 15 micrograms of mRNA against the parent strain and 15 micrograms against the BA.4 and BA.5 variants. It is approved for people 12 years of age.
The company is also updating its shots for children ages 5 to 11, and will seek FDA approval of these updated boosters in early October. Works with FDA to update vaccines for children ages 6 months to 4 years. Moderna’s bivalent booster is a 50-microgram dose, with 25 micrograms of mRNA designed to fight the ancestral strain of the coronavirus and 25 micrograms of mRNA designed to fight the BA.4 and BA.5 variants. It is authorized for persons 18 years of age and older.

Where and when can I get an updated Covid-19 booster?

The government has already taken orders for these vaccines, and now that the FDA has approved them, millions of doses will be shipped to tens of thousands of locations across the country. These include community health centres, health departments and pharmacies. As with previous Covid-19 vaccines, these vaccines will be available free of charge. But they may be some of the last Covid-19 freebies from the government, which has said it is set to start marketing treatments and vaccines this autumn. Pfizer says it has the ability to ship up to 15 million doses by September 9. The panel of experts that advises the U.S. Centers for Disease Control and Prevention on vaccine recommendations reviewed the science behind the vaccines Thursday and voted to recommend them. Then CDC Director Dr. Rochelle Walensky, signed off, which means people can start taking the shots right away. “What I expect is, after the CDC action, you’re going to start to see some places start giving some shots over the weekend, but very relatively few because [of the] Labor Day weekend. And my expectation is over the next week, or certainly in the next 10 days, you’ll start to see these bivalent vaccines become widely available across the country,” said Dr. he told CNN. The Biden administration expects appointment availability to increase in the first few days, with widespread availability in a few weeks. People will be able to find locations on Vaccines.gov. The administration is also preparing to launch a campaign urging Americans to get their annual flu shot along with an updated Covid-19 booster. Research on this approach shows that it is safe. Updated Covid-19 vaccinations will be the only game in town in terms of boosters, at least for those aged 12 and over. The FDA says the older boosters are no longer authorized for this age group, but will still be available as boosters for children ages 5 to 11.

How do we know the updated Covid-19 vaccines work?

These are the first Covid-19 vaccines to be approved for use in humans after being tested only in mice. This is roughly the same process that is followed each year when the annual flu shots are updated. The FDA has allowed companies to submit data from animal testing in order to expedite these downloads to the public. Human studies are ongoing, according to Pfizer’s Gruber. Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said he expects it will be a month or two before human data are available. Officials say the urgency with these boosters is warranted since the fall, when Covid-19 is still circulating at high levels and the flu is expected to return. But the decision to rely on animal studies has caused some controversy. Some vaccine experts believe that animal studies do not provide sufficient evidence for these vaccines at this stage of the pandemic. “You’re asking people to take a new product that has no data,” Dr. Paul Offit, who directs the vaccine education center at the Children’s Hospital of Philadelphia. “Mice data insufficient to launch 100-plus billion-dose effort.” Offit says it makes sense to use data from animal studies for updates to annual flu shots because we’ve used these vaccines for decades and understand what biomarkers to look for when measuring whether they’re working. These so-called protective associations are not as well understood for Covid-19 vaccines.
It’s not just the shots that are different, Poland said. At this point in the pandemic, our immune systems are too. Almost all Americans have been infected with the coronavirus, vaccinated, or both. Some people have had four or five doses of the vaccine. “If you say to me, ‘can you assure me that getting dose five or dose six of this new vaccine on top of getting these previous doses is perfectly safe?’ I’d say ‘no, I can’t.’ We’re extrapolating. And I think we should be clear about that,” Poland said. FDA officials point out that animal studies weren’t the only data they looked at in making their decision. They looked at two other lines of evidence.
The first is vaccine history. The same basic vaccines have now been given to hundreds of millions of people around the world. They have proven highly effective in preventing serious illness and death from Covid-19. The risks associated with mRNA vaccination are very, very low.
The second line of evidence comes from bivalent vaccines that may soon be used in Europe.
Earlier this year, Pfizer and Moderna presented an independent panel of experts advising the FDA with data on a bivalent vaccine designed to target Omicron’s original strain, BA.1. These data showed that the vaccines boosted antibody responses and were well tolerated. The UK has approved these vaccines, but they will not be available in the US. The BA.1 strain is no longer available, and the FDA has asked manufacturers to update their US downloads to include BA.4 and BA.5 instead.
Marks said in a briefing Wednesday that some evidence suggests that the BA.4 and BA.5 strains generate a stronger immune response than BA.1, which is another reason officials wanted to include them in the updated shots. FDA Commissioner Dr. Robert Califf said he understands people may want to know more, but he is confident these vaccines are safe and effective. “It’s fair for people to raise questions. But this is really the best consensus we have among experts that this is the best way to go… It’s just painful to see people die needlessly when there’s a free treatment that will prevent death told them. “I’ll be in the front line at the pharmacy to get my shot,” said Califf, who turns 71 next month. “I am very sure of it.” In the past, vaccine trials for specific variants have had inconclusive results. It is difficult to know what effect these bivalent vaccines might have.
In a recent preprint study, published before peer review, scientists tried to assess this with a meta-analysis, or review of studies. They gathered estimates of antibody levels after booster doses against the ancestral strains, as well as against specific variants, and tried to use those levels to predict how well the shots would work. They found that people get the most benefits from reinforcement, period. A booster against the ancestral strain of the virus that causes Covid-19 increased neutralizing antibodies 11-fold. The scientists calculated that this would increase a person’s protection against symptomatic infection over the next six months from 50% to 86.5%.
Variant-specific amps performed slightly better, but the difference wasn’t dramatic. After these shots, protection against symptomatic infection over the next six months rose to 90.2%, just a 4.6% increase.

Are Covid-19 boosters safe?

A recent review of adverse events following mRNA booster vaccinations in adults in the United States found that adverse events were less common after booster doses than after second doses of the vaccine, and most were mild. About 1 in 8 adults reported headache, fever, or pain after a booster. In children and adolescents, the most commonly reported side effects after boosters were injection site pain, fatigue, headache, and muscle aches. Very rarely, mRNA vaccines can cause myocarditis, or swelling in or around the heart. After more than 80 million booster doses were given in the United States, government safety surveillance systems received 37 verifiable reports of myocarditis. Most of these were in men. The highest rates of myocarditis in adults were in younger men — ages 18 to 24. For every million booster doses given to men this age, the CDC expects about that many will have myocarditis. For teenagers, the rate is slightly higher but still extremely low: about 11 cases of myocarditis for every million doses. Marks said that to minimize that risk, officials are directing that…