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But doctors often recommended the monoclonal antibody for people taking certain immunosuppressive medications, such as cancer patients or transplant recipients, since Paxlovid can interact negatively with several of those drugs. Casadevall said convalescent plasma is an effective alternative to monoclonal antibodies, but it's more complicated to administer and oversee. Pharma companies haven't given up on the promise of new monoclonal antibody drugs, however. A spokesperson for Eli Lilly said the company is searching for and evaluating monoclonal antibody candidates. Casadevall said new monoclonal antibody drugs are still worth pursuing, since they have proven safe and effective against Covid.

☆ FDA pulls Covid antibody treatment because it's not effective against dominant omicron variants
▼ + stars: | 2022-12-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

A key monoclonal antibody used to treat people with weak immune systems who catch Covid is no longer authorized for use in the U.S. because it is not effective against emerging omicron subvariants. The FDA, in a notice Wednesday, said bebtelovimab is not approved for use because it is not expected to neutralize the omicron BQ.1 and BQ.1.1 subvariants. They are causing 57% of new infections nationally and make up a majority of cases in every U.S. region except one. But bebtelovimab stocks should be kept on hand in the event that Covid variants which the antibody can neutralize become dominant again in the future, according to FDA. Many people with weak immune systems, such as organ transplant patients, cannot take Paxlovid with other medications they need.

☆ FDA Pulls Lilly’s Covid Antibody Drug
▼ + stars: | 2022-11-30 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Eli Lilly and Co. said it has paused distribution of the drug until further notice by the Food and Drug Administration, and advised healthcare providers to store unused bebtelovimab in case it can be used against other coronavirus variants. The Food and Drug Administration said a Covid-19 antibody treatment from Eli Lilly & Co. is no longer authorized for use because it isn’t likely to be effective against certain Omicron offshoots now dominant in the U.S. The subvariants, called BQ. 1.1, now cause more than half of new Covid-19 cases in the U.S., the FDA said on Wednesday. Yet Lilly’s drug, bebtelovimab, doesn’t retain neutralizing activity against the subvariants, the company said.

☆ FDA pulls U.S. authorization for Eli Lilly's COVID drug bebtelovimab
▼ + stars: | 2022-11-30 | by ( ) www.reuters.com time to read: +1 min

Nov 30 (Reuters) - Eli Lilly and Co's COVID-19 drug bebtelovimab is not currently authorized for emergency use in the United States, the Food and Drug Administration said, citing it is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron. Wednesday's announcement takes away authorization from the last COVID-19 monoclonal antibody treatment, leaving Pfizer Inc's (PFE.N) antiviral drug Paxlovid, Merck's (MRK.N) Lagevrio and Gilead Sciences' (GILD.O) Veklury as treatments for the disease, besides convalescent plasma for some patients. AstraZeneca Plc's monoclonal antibody Evusheld is also authorized for protection against COVID-19 infection in some people. The drug, which was discovered by Abcellera (ABCL.O) and commercialized by Eli Lilly, received an authorization from the FDA in February. BQ.1 and BQ.1.1 have become the dominant strains in the United States after a steady increase in prevalence over the last two months, surpassing Omicron's BA.5 sub-variant, which had driven cases earlier in the year.

☆ Dr. Jha: The U.S. is ready to 'move on' from Covid if people 'keep their immunity up to date'
▼ + stars: | 2022-11-29 | by ( Renée Onque | ) www.cnbc.com time to read: +1 min

The U.S. is getting closer than ever to finally putting Covid in the rearview mirror, according to Dr. Ashish Jha. "The good news is: People can move on if they keep their immunity up to date." Currently, that means a primary series of Covid vaccines followed by a booster shot with an omicron component, according to the Centers for Disease Control and Prevention. The omicron booster shot provides a particularly strong immune response against omicron subvariants like BA.4 and BA.5, recent data from Pfizer and BioNTech shows. But Jha hopes that figure will rise in the coming weeks, as more people get flu shots and potentially knock out both vaccines simultaneously.

☆ Omicron BQ Covid variants that threaten people with compromised immune systems are now dominant in U.S.
▼ + stars: | 2022-11-25 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

A person receives a coronavirus disease (COVID-19) test as the Omicron coronavirus variant continues to spread in Manhattan, New York City, U.S., December 22, 2021. The omicron BQ coronavirus subvariants have risen to dominance in the U.S. as people gather and travel for the Thanksgiving holiday, putting people with compromised immune systems at increased risk. The omicron BA.5 subvariant, once dominant, now makes up only a fifth of new Covid cases. The BQ subvariants are more immune evasive and likely resistant to key antibody medications, such as Evusheld and bebtelovimab, used by people with compromised immune systems, according to the National Institutes of Health. President Joe Biden, in an October speech, told people with compromised immune systems that they should consult with their physicians and take extra precautions this winter.

☆ New subvariants, family gatherings may bring more Covid-19 after holiday, but experts don’t expect severe surge
▼ + stars: | 2022-11-24 | by ( Brenda Goodman | ) edition.cnn.com time to read: +9 min

Experts expect that Thanksgiving gatherings will stir up social networks and give new coronavirus subvariants fresh pockets of vulnerable people to infect. And we are concerned that after holiday gathering, lots of people coming together, that we may see increases in Covid-19 cases as well,” Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said Tuesday on CNN. For the week ending Nov. 19, the CDC estimates that BQ.1 and BQ.1.1 were causing about half of all new Covid-19 cases in the US. Covid-19 cases, hospitalizations and deaths have remained flat for the past four weeks. “It’s probably got a bit more of a fitness advantage, so what we’re seeing is gradual replacement without a massive change in the total number of Covid-19 cases,” he said.

Nov 24 (Reuters) - Recent uptake of COVID-19 vaccine booster doses in the European Union has been "rather disappointing," an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter. WHO data released late on Wednesday showed that 724,000 new COVID-19 cases were reported in the EU over the past week, down 11% from the previous week. In early October, when experts were warning of a new COVID-19 wave, the number of weekly cases reached 1.5 million. The EMA intends to issue new guidelines for health care providers on the issue of such treatments, he said. But prompt access to Paxlovid remains an issue in the EU, and the EMA is working with governments to change this, he said.

☆ Thanksgiving Poses Next Covid-19 Test as U.S. Looks to Dodge Severe Surge
▼ + stars: | 2022-11-23 | by ( Jon Kamp | ) www.wsj.com time to read: +1 min

Thanksgiving once again comes at a precarious time this year, as new Covid-19 subvariants take over and the cold weather brings people indoors, often in family gatherings where the virus can easily spread. The U.S. is heading into its third Covid-19 Thanksgiving in better shape than the last two, but holiday gatherings will provide a test of whether the nation can avoid another major winter surge, epidemiologists and virus experts say. Thanksgiving once again comes at a precarious time, as new subvariants take over and the return of cold weather brings people back indoors, often in family gatherings where the virus can easily spread. The holiday last year coincided with the arrival of an early version of the Omicron variant that kicked off an explosive rise in cases and the second-deadliest Covid-19 wave. Only the prior winter, when vaccination efforts were just beginning, saw a higher peak in deaths.

People who got the updated booster shots after two or more shots of the original vaccine were compared to another group of people who received only two or more doses of the original vaccine. The updated booster shots performed better in preventing infections in all adult age groups, with higher vaccine efficacy seen in people who waited longer before getting the updated booster, the CDC found. He noted that studies have shown longer intervals between Covid vaccine doses can lead to higher antibody levels. Previous Covid infections may be underreported, the agency said, and low uptake of the updated boosters could have affected the results. New subvariants BQ.1.1 and BQ.1 are on the rise in the U.S., she said, and it’s unclear how the updated boosters will perform against those strains.

☆ Updated boosters add limited protection against Covid-19 illness, first real-world study shows
▼ + stars: | 2022-11-22 | by ( Brenda Goodman | ) edition.cnn.com time to read: +8 min

The new study found that the updated boosters work about like the original boosters. Compared with people who were unvaccinated, adults 18 to 49 who had gotten bivalent boosters were 43% less likely to get sick with a Covid-19 infection. The relative vaccine effectiveness showed the added protection people might expect on top of whatever protection they had left after previous vaccine doses. So overall, the updated boosters got them to around 50% effectiveness against symptomatic infection. According to CDC data, roughly two-thirds of Americans have completed at least their primary series of Covid-19 vaccines.

☆ Updated COVID vaccines offer better protection than original -U.S. study
▼ + stars: | 2022-11-22 | by ( ) www.reuters.com time to read: +2 min

Nov 22 (Reuters) - Updated COVID-19 boosters offer increased protection against new variants in people who have previously received up to four doses of the older vaccine, a real-world study in the United States showed. The study of over 360,000 people, published in Morbidity and Mortality Weekly Report, offers the first evidence that the new vaccines by Pfizer-BioNTech (PFE.N)(22UAy.DE) and Moderna (MRNA.O) provide better protection compared to the original shots. Since their introduction in September, the vaccine boosters, which contain both original and Omicron BA.4/5 coronavirus strain, provided greater benefit to younger adults aged 18-49 years that those in the older age group. The variation in effectiveness was lower, in the range of 28-31%, when the boosters were given 2-3 months apart. The authors warned that the study may not be generalizable to future variants, as the dominant variants keep changing.

☆ Pfizer says omicron booster is better against new subvariants like BQ.1.1 than old shots
▼ + stars: | 2022-11-18 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Pfizer said its omicron booster triggers a stronger immune response against a number of emerging Covid subvariants circulating the U.S. Pfizer developed its booster against omicron BA.5 at the request of the Food and Drug Administration. Among the emerging subvariants, the omicron booster elicited the strongest immune response against BA.4.6 with antibodies 11 times higher, and the weakest response against XBB.1 with antibodies about 5 times higher. Moderna on Monday said its omicron booster induces an immune response against BQ.1.1 though the company didn't provide specifics. Pfizer and Moderna's new boosters target both omicron BA.5 and the original strain of Covid that emerged in Wuhan, China in 2019.

☆ Pfizer/BioNTech's updated COVID shot shows strong response against BQ.1.1
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +2 min

Nov 18 (Reuters) - Pfizer Inc (PFE.N) and its German partner BioNTech SE said on Friday their Omicron-tailored shot produced higher virus-neutralizing antibodies in older adults against the emerging subvariant BQ.1.1 than its original vaccine. Antibody levels against the variant rose nearly nine-fold in older adults, aged 55 and above, who received the Omicron shot compared to a roughly 2-fold increase in participants with the original shot, according to data posted on online archive bioRxiv. The variant and related BQ.1 are gaining ground in the United States, and are expected to cause a rise in cases in the winter in Europe. The companies had recently released data that showed their Omicron-tailored shot produced a strong antibody response in older adults than the original shot after one month against the BA.4/5 subvariants. Pfizer and BioNTech said the bivalent shot also produced an immune response against newer Omicron subvariants including BA.4.6, BA.2.75.2 and XBB.1.

☆ Loads of Covid-19 Boosters Are Going Unused This Fall and Here’s Why
▼ + stars: | 2022-11-17 | by ( Stephanie Armour | Brianna Abbott | ) www.wsj.com time to read: 1 min

Uptake of fall Covid-19 booster shots remains anemic well into November, frustrating public-health experts who blame the lackluster interest on pandemic fatigue and insufficient outreach from officials. About 31 million people in the U.S. have gotten the updated shots, or roughly 10% of people ages five and older, according to data from the Centers for Disease Control and Prevention. The federal government purchased more than 170 million doses of the new bivalent boosters that target two Omicron subvariants and the original virus strain.

Two new omicron subvariants have overtaken BA.5 as the prevailing versions of the coronavirus in the U.S.BA.5 became dominant in July, then consistently accounted for the majority of new Covid infections until last week. The two together make up around 44% of new Covid infections, whereas BA.5 makes up just 30%. BQ.1.1 and BQ.1 cases are also rising in the U.K. and elsewhere in Europe. Both of the subvariants are considered part of the BA.5 family — they're sublineages that evolved from BA.5. "There’s nothing in the signature of the clinical cases that are being reported that suggests that anything is changing in terms of symptoms with these omicron subvariants," Pekosz said.

In fact, Covid-related deaths and hospitalizations have fallen in recent months, despite the emergence of new omicron subvariants that evade immunity from previous infections and vaccination. Full coverage of the Covid-19 pandemicAccording to NBC News data, Covid deaths have fallen consistently since Aug. 31, when the seven-day average of daily Covid deaths was at 571. The average number of Covid hospitalizations per day has decreased by 27.9% since Aug. 28, according to NBC News data. While Covid-related hospitalizations are not currently increasing, Gupta warns that they could during the winter as immunity, especially from previous infection, diminishes. Now, he said, "Covid deaths don't all look the same."

Moderna’s updated Covid booster appears to increase the immune response to omicron subvariants BA.4 and BA.5, as well as another subvariant, called BQ.1.1, that's gaining ground in the United States, the company said in a release Monday. The results are based on blood samples taken from 511 adults who got the updated booster, which targets BA.4 and BA.5, along with the original coronavirus strain, in a single shot. In people who got the updated booster, neutralizing antibodies against BA.4 and BA.5 were about fivefold higher in those with a previous Covid infection and sixfold higher in those without a documented infection, the company said. Moderna also said an additional analysis of 40 people found the updated booster demonstrated “robust neutralizing activity” against the subvariant BQ.1.1, though the response wasn’t as strong as what was seen against BA.4 and BA.5. Earlier this month, Pfizer and BioNTech said their updated booster shot generated a stronger immune response against BA.4 and BA.5 compared with their original Covid vaccine.

☆ Moderna’s New Covid-19 Booster Produced Strong Immune Response in Study
▼ + stars: | 2022-11-14 | by ( Peter Loftus | ) www.wsj.com time to read: 1 min

Moderna’s updated booster shot targets both the original strain of the coronavirus and the BA.4 and BA.5 subvariants, which share an identical surface protein. Moderna Inc.’s new updated Covid-19 booster shot for the U.S. generated strong immune responses in people against Omicron subvariants, according to the first data from a company-sponsored study testing the new doses in volunteers. Moderna said Monday that people receiving the updated booster shot had more than five times the neutralizing antibodies against Omicron subvariants BA.4 and BA.5 than people who received Moderna’s original booster shot, which targeted an earlier strain of the coronavirus.

☆ Moderna's Omicron shots shows better immune response than original COVID vaccine
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +1 min

Nov 14 (Reuters) - Moderna Inc (MRNA.O) said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said. Moderna, however, said levels of neutralizing antibody response dropped nearly 5-fold against the emerging subvariant BQ.1.1 when compared with BA.4/5, in an analysis of about 40 participants, although the virus neutralizing activity still remained "robust". Rival Pfizer Inc (PFE.N) and its German partner, BioNTech SE , said earlier this month their Omicron-tailored shot targeting the BA.4/5 subvariants produced a strong antibody response in older adults than the original shot after one month. Reporting by Bhanvi Satija in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

☆ Moderna says Covid booster better against omicron BA.5, triggers immune response against BQ.1.1
▼ + stars: | 2022-11-14 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Moderna's new Covid booster triggered a stronger immune response against omicron BA.5 and also appears to work against the emerging BQ.1.1 subvariant, according to the company. Moderna, in clinical trial data published Monday, found that the new booster triggered five times more antibodies against omicron BA.5 than the old vaccines in people with prior Covid infections. Moderna said it also found the new booster triggered robust immune response against omicron BQ.1.1, an emerging Covid subvariant in the U.S. Pfizer also released data earlier this month indicating that the boosters provide better protection against omicron BA.5 than the old shots. Two independent studies from Columbia and Harvard found that the boosters did not do a much better job against omicron BA.5.

☆ Omicron BQ variants resistant to antibody treatments are quickly becoming dominant in U.S.
▼ + stars: | 2022-11-11 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

Omicron subvariants resistant to key antibody treatments will soon make up a majority of new Covid infections in the U.S., according to the Centers for Disease Control and Prevention. Many people with moderate or severely compromised immune systems take an antibody cocktail called Evusheld to protect them from severe disease. This leaves people with compromised immune systems increasingly vulnerable as these subvariants become dominant. White House Covid response coordinator Dr. Ashish Jha has blamed Congress for failing to pass additional funding for the nation's pandemic response. President Joe Biden last month altered people with compromised immune systems that they face a special threat from Covid this winter.

☆ U.S. is extending Covid public health emergency through spring 2023, administration official says
▼ + stars: | 2022-11-11 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The U.S. is extending the Covid public health emergency through the spring of 2023, a Biden administration official said on Friday. The decision to extend emergency comes as public health officials are expecting another Covid surge this winter as people gather more indoors where the virus spreads easier. The Health and Human Services Department previously extended the public health emergency until January. The public health emergency, first declared in January 2020 and renewed every 90 days since, has had a vast impact on the U.S. health-care system. The declaration has dramatically expanded public health insurance through Medicaid and the Children's Health Insurance Program.

☆ U.S. will keep Covid public health emergency in place at least until mid January
▼ + stars: | 2022-11-11 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The U.S. Covid public health emergency will remain in place past Jan. 11 after the federal government did not notify states or health-care provides on Friday of any intent to lift the declaration. In October, HHS extended the public health emergency until Jan. 11. Public health officials are expecting another Covid surge this winter as people gather more indoors where the virus spreads easier. The declaration has dramatically expanded public health insurance through Medicaid and the Children's Health Insurance Program. Correction: HHS clarified that public health emergency remains in place for at least another 60 days, which is mid January.

☆ COVID variants BQ.1/BQ.1.1 make up 44% of U.S. cases - CDC
▼ + stars: | 2022-11-11 | by ( ) www.reuters.com time to read: +1 min

[1/2] The word "COVID-19" is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. BQ.1.1 accounted for nearly 24.1% of circulating variants and BQ.1 was estimated to make up 20.1% of circulating cases for the week ending Nov. 12, the U.S. CDC said. While there is no evidence linked to the increased severity of the new variants compared to BA.4 and BA.5, they have shown an increasing presence in Europe, Singapore, Canada, among other places. The BA.5 subvariant is estimated to make up about 29.7% of cases in the United Sates, compared with nearly 41.1% in the week ended Nov. 5, according to the CDC. Reporting by Khushi Mandowara; Editing by Vinay Dwivedi and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

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