Here are a couple of new articles on the new vaccines followed by ordering information. One has to do with whether one should get a second booster vaccine before the new ones are out from the New York Times. There is also an article of Pfizer’s approval request to the FDA for its new vaccine.
Should I get a fourth shot now, or wait for an Omicron-specific booster?
On Aug. 15, Britain became the first country to authorize a booster vaccine designed to target the Omicron variant in addition to the original coronavirus. The new vaccine is bivalent, meaning it will combat two variants of the virus.
A similar booster is likely coming to the U.S. in the fall. (The shot that Britain approved is meant to protect against the first strain of Omicron, which sent cases surging this past winter, while the U.S. is waiting on a vaccine that can specifically target BA.5, the version of the virus that is currently dominant.) The Biden administration expects to roll out these retooled vaccines in September, although it is unclear exactly when Pfizer and Moderna, the companies producing the vaccines, will make them available; when the Food and Drug Administration will authorize them; and which populations will be cleared to receive them first. The new boosters may roll out first to groups that are at higher risk of severe outcomes from Covid, such as older and immunocompromised people, before being made available to others.
With that new booster shot on the horizon, doctors and infectious disease experts said they were fielding questions as to whether people should get a fourth shot now or wait for the Omicron-specific booster.
If you are eligible for a fourth shot:
The C.D.C. recommends that people receive booster shots as soon as they become eligible. Currently, all adults who are 50 or older, and people who are 12 and older and are immunocompromised can receive a fourth shot.
Experts agreed that those who qualified for the booster shot now should get it. The older you are, the more important it is to get a fourth shot, said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco.
In general, if you have not received a vaccine or recovered from a Covid infection in the past six months, “getting a booster is a good idea,” said Shane Crotty, a virologist at the La Jolla Institute for Immunology.
If you are not yet eligible for a fourth shot:
Despite the C.D.C.’s recommendations, experts acknowledged that people who are not technically eligible for a fourth shot are getting them. Some have timed their second boosters to strategically “top up” their antibodies, Dr. Chin-Hong said, scheduling shots before a wedding or a trip abroad.
However, experts said, if you are under 50 and do not have underlying health conditions, and you have already received one booster shot previously, you can wait for the Omicron-specific booster shot.
People with “hybrid immunity” — those who have received a booster shot in the past and recovered from a Covid infection — should also consider waiting for the Omicron-specific shot, said Dr. Paul Sax, an infectious disease expert at Brigham and Women’s Hospital and a professor at Harvard Medical School. Unless someone is immunocompromised or elderly, “it doesn’t make a whole lot of sense for them to run out and get another vaccine now,” he said.
Aubree Gordon, an epidemiologist at the University of Michigan, said the general recommendation was for people to wait five months between booster doses. While the Covid vaccines are safe and effective, back-to-back booster shots are unlikely to add much benefit.
“If you get a booster now and you get another booster Sept. 15, don’t expect that second shot to do anything,” Dr. Crotty said.
While the anticipated Omicron-specific shot will offer better protection against the variant currently circulating in the United States, it won’t guarantee protection from infections.
“Boosters against Omicron are not going to be a magic shield,” Dr. Crotty said. But experts agree that any Covid vaccine you get — the booster available now or an Omicron booster in the fall — is meant to prevent severe disease. So far, all Covid vaccines have been extremely effective in preventing hospitalizations and death.
Dani Blum is an associate writer for Well at The Times.
The following article is from CNBC.
Pfizer asks FDA to authorize Covid booster shots that target omicron BA.5 for people ages 12 and older
- Pfizer and its German partner BioNTech have asked the FDA to authorize updated Covid booster shots that target the omicron BA.4 and BA.5 omicron subvariants.
- The U.S. is planning a fall booster campaign with the new shots amid concerns about another wave of infection.
- Public health officials hope the new shots will provide more durable protection against infection and mild illness, but some experts say not enough data has been presented.
The U.S. is preparing for a fall vaccination campaign using updated vaccines that target the dominant omicron subvariants. Public health officials expect another wave of infection this fall and winter as immunity from the currently authorized shots wears off and people head indoors to escape the colder weather.
The updated vaccines would target the original strain of the virus that first emerged in Wuhan, China, in 2019 as well as omicron, known as a bivalent vaccine. Scientists and public health officials hope the new shots will provide broader and more durable protection against infection and mild illness.
The currently authorized shots were developed to target the version of Covid that first emerged in China. Though the original vaccines are still preventing severe disease, they are not providing substantial protection against infection and mild illness.
Dr. Ashish Jha, the White House Covid response coordinator, has said the new shots will become available to the public by early to mid-September. Pfizer said it can ship the omicron BA.4/BA.5 boosters as soon as the FDA authorizes them. The U.S. government has secured 105 million doses of Pfizer’s updated shots and 66 million doses of Moderna’s new vaccine.
The FDA is working closely with the vaccine manufacturers to ensure the updated Covid boosters are available in the fall after a review of the safety and effectiveness of the shots, according to agency spokesperson Abby Capobianco.
“The agency will work expeditiously to review this and any other submissions once received in order to make modified COVID-19 vaccines available for booster vaccination in this timeframe,” Capobianco said.
However, some infectious disease and public health experts are calling for the FDA and the vaccine companies to present more data on the new shots before they receive authorization. It’s unclear whether or not the FDA’s independent vaccine advisory committee will meet to review more data on the shots before the agency authorizes them.
Publicly available data on the Pfizer’s shots that target omicron BA.4 and BA.5 is sparse right now and based on studies in mice. In June, Pfizer presented data to the FDA’s independent vaccine advisory committee that showed the bivalent omicron shots increased antibodies in mice that protect against infection by about 2.6 fold compared with the original vaccine.
Dr. Paul Offit, a member of the FDA advisory committee, said it makes sense that a vaccine which includes the omicron subvariants would bolster the immune response in humans. But Offit said data from mice is not enough to demonstrate that is the case. The vaccine companies and the FDA need to present human data to the public that shows a dramatic increase in neutralizing antibodies from the omicron BA.4 and BA.5 shots in people compared with the original vaccine, he said.
“You have to show some evidence in people that the immune response that you’re getting with the bivalent vaccine is clearly better, and those data haven’t been presented,” said Offit, an infectious disease and vaccine expert at Children’s Hospital of Philadelphia.
“You can’t ask millions of people to get this booster dose without showing some human data that you have a dramatic increase in neutralizing antibodies to the BA.4/BA.5 strains as compared to boosting with the ancestral type,” Offit said, referring to the currently authorized shots based on the version of Covid that emerged in Wuhan, China, more than two years ago.
Michael Osterholm, a leading epidemiologist at the Center for Infectious Disease Research and Policy in Minnesota, also said more data needs to be presented on how the BA.4/BA.5 shots perform in humans.
“It’s not that I don’t think it could work,” Osterholm said. “But I think we need the data first to show that the immune response to this vaccine is equivalent to or better than what we have already.”
Dr. Peter Hotez, an infectious disease and vaccine expert at Baylor College of Medicine in Texas, said it’s worth waiting a little longer for human data on the omicron shots. Hotez led a team that developed a Covid vaccine based on protein technology that is authorized in India.
“I would be surprised if the FDA would move forward on the whole show just based on mouse data alone,” Hotez said. “It’s just a matter of a few extra weeks to get essentially human data. I think it’s worth it because remember, the American people are not rushing to get boosted anyway,” he said.
Omicron BA.5 is the dominant strain of Covid circulating in the U.S. right now, making up about 90% of new infections, according to the Centers for Disease Control and Prevention. The omicron BA.4 and BA.4.6 subvariants represent a little more than 10% of new infections taken together. These versions of omicron are more contagious than past variants of Covid.
Pfizer was originally developing a booster that targets the first version of omicron, BA.1, that caused the massive wave of infection over the winter. But omicron has continued to mutate, and the FDA asked the vaccine makers this summer to switch gears and focus on BA.4 and BA.5.
TO ME IT DOES MAKE SENSE TO WAIT FOR HUMAN DATE RATHER THAN JUST RELYING ON DATA FROM MICE. I THINK WE WILL STILL WANT TO GET THIS ONE, BUT I”D LIKE TO SEE WHAT THE DATA IN HUMANS IS.
And finally, ordering information from the Texas Department of State Health Services:
August 22, 2022
Dear COVID-19 Vaccine Providers,
In anticipation of the potential Emergency Use Authorizations (EUAs) by the Food and Drug Administration of new bivalent COVID-19 vaccine boosters, Texas Department of State Health Services (DSHS) is requesting all providers place a pre-order for these new COVID-19 vaccines in the Vaccine Allocation and Ordering System (VAOS) for both Pfizer and Moderna products.
Pre-ordering Wave 1 is open effectively immediately through August 23, 2022. Wave 2 pre-ordering will be from August 24 through August 30, 2022.
Vaccine orders will begin shipping only after the issuance of the EUAs which is unknown at this time. DSHS will provide a shipping update once EUAs are issued.
Bivalent COVID-19 Vaccine Booster
- The new vaccine will contain the current COVID-19 vaccine plus an Omicron BA.4/5 variant specific vaccine in equal parts (bivalent).
- Both Pfizer and Moderna have developed a COVID-19 bivalent vaccine booster that are available for pre-ordering.
- The bivalent COVID-19 vaccines will likely be authorized as a single dose.
- Additional clinical considerations will follow after the CDC makes its recommendations.
- Pfizer bivalent COVID-19 vaccine booster is expected (pending EUA) for individuals >12 years.
- Moderna bivalent COVID-19 vaccine booster is expected (pending EUA) for individuals >18 years.
- The new bivalent COVID-19 vaccine booster will have the same storage and handling requirements as the current vaccine products from the respective manufacturers.
- Pfizer bivalent COVID-19 vaccine booster will be available in 6-doses per vial with a minimum order quantity of 300 doses.
- Moderna bivalent COVID-19 vaccine booster will be available as 5-doses per vial, with a minimum order quantity of 100 doses.
- Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. An ancillary opt-out continues to be available for all non-diluent kits.
DSHS will provide updates on the expected EUAs and shipping as they become available. DSHS greatly appreciates your continued partnership with COVID-19 vaccination efforts.
Texas Department of State Health Services
STAY TUNED!
