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A Covid outbreak at an American scientific research station in Antarctica has forced U.S. officials to temporarily halt all travel to the remote outpost. The agency confirmed that 10% of the research station’s population have tested positive for Covid during this recent outbreak. There are 885 people currently living and working at McMurdo Station. Though the station operates year-round, many scientists typically travel to McMurdo in November for field research during Antarctica’s summer season. It’s not yet clear what, if any, impact the outbreak could have on research and operations at the outpost.
BioNTech lifts lower end of vaccine sales target range
  + stars: | 2022-11-07 | by ( ) www.reuters.com   time to read: +1 min
FRANKFURT, Nov 7 (Reuters) - COVID-19 vaccine maker BioNTech (22UAy.DE) on Monday raised the lower bound of its 2022 COVID-19 vaccine revenue guidance for the full year, citing demand for its adapted shots and higher prices. The German biotech firm, the vaccines partner of U.S. pharma giant Pfizer (PFE.N), said in a statement that it is now targeting 16 to 17 billion euros ($16-$17 billion) in vaccine sales, compared with a previous range of 13-17 billion but down from 19 billion euros reported for last year. Partner Pfizer last week raised its forecast for its 2022 sales of the COVID-19 vaccine by $2 billion to $34 billion. Sales during the July-to-September quarter dropped 43% to 3.46 billion euros while net profit fell 44% to 1.78 billion euros. Sales of the Pfizer/BioNTech COVID vaccine are down from pandemic highs as many countries have neared the end of their primary vaccination campaigns.
The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. But there's a new batch of so-called "Scrabble" variants circulating globally. But experts still expect the shots to ramp up your immunity against all Covid variants, to some degree. The Scrabble variants are descendants of omicronThe new variants are descendants of omicron, which is a promising initial sign for the boosters. That can "restore a level of immunity and patch up the holes that some of these new Scrabble variants have found," she explains.
An outbreak of Covid at the McMurdo Station in Antarctica has disrupted life for researchers and support staffers at the southern end of the world. The research station has a population of 885, the statement said, meaning more than 8% of those have tested positive for the coronavirus so far. The outbreak is a reminder that Covid is still a threat to close-knit workplaces and that the virus is still roiling scientific research in remote sites. Because McMurdo is such a remote location, stringent measures were implemented during past field seasons to keep Covid from circulating. “As COVID cases and population at McMurdo Station continue to increase, individuals may be assigned to rooms with COVID positive roommates.”The email encouraged physical distancing and the use of masks.
CNN —Pfizer and BioNTech said Friday that the immune responses against Omicron BA.4/BA.5 subvariants were “substantially higher” in people who got its new bivalent booster compared with people who received the companies’ original Covid-19 vaccine. The bivalent booster that targets the original coronavirus strain and the Omicron BA.4 and BA.5 subvariants became available in the US in early September. When someone gets any vaccine, it can take a few weeks to build up immunity and generate its full protection. The Omicron BA.5 subvariant had dominated US Covid-19 infections since July, but a mix of other Omicron subvariants have been gaining against it. So far, 26.3 million people age 5 and older in the United States have received updated Covid-19 boosters.
Pfizer and BioNTech also found that people with and without prior Covid infections had a significant increase in their antibody levels after the omicron boosters. Pfizer and BioNTech released more human data Friday indicating the omicron BA.5 boosters perform better than the old Covid shots. Pfizer and BioNTech released the first human data in October showing the omicron boosters trigger a better immune response. They found the new boosters and the old shots performed about the same against omicron BA.5. The scientific community and public health officials are closely following data on the boosters because the FDA authorized them without direct human data.
BERLIN, Nov 2 (Reuters) - Swiss drugs regulator Swissmedic said on Wednesday it is examining potential risks in connection with bubbles that appeared in vials of COVID-19 vaccine boosters retooled to target the Omicron variant of the coronavirus. "Vials of the batch concerned contained bubbles after being removed from the fridge," said Swissmedic, adding that the phenomenon seems to be accentuated when the syringes were prepared several hours in advance. Cantons and vaccination centres have been informed as a precaution, the regulator said. A BioNTech spokesperson said Pfizer was in charge of the supply chain and distribution in Switzerland and had no further immediate comment. Writing by Miranda Murray; Editing by Thomas Escritt and Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.
Pfizer’s vaccine candidate is administered to pregnant women who then make antibodies that cross the placenta and protect the baby after birth. In March, the FDA designated Pfizer’s RSV vaccine a breakthrough therapy, a status that speeds its review. Pfizer’s vaccine contains the virus’ F-protein, the site that it uses to attach to human cells. Pfizer’s RSV vaccine is bivalent, containing F-proteins from both the A and B subgroups of the RSV virus, which are the two most commonly circulating strains. “Further analysis to better understand safety data from these trials is ongoing,” spokesperson Alison Hunt said in a statement to CNN.
The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. The Food and Drug Administration said two studies this week showing that the new omicron boosters weren't that much better than the old shots were too small to come to any real conclusions. The antibody responses were slightly higher with the omicron boosters, though the studies concluded the difference wasn't significant. The studies are of public interest because there's very limited human data on how the omicron BA.5 boosters perform right now. The FDA also looked at data directly on the BA.5 shots that came from animal studies.
Similar immune responsesThe studies have important limitations, and they aren’t the final word on the updated boosters. In Barouch’s study, antibody concentrations were 15 times higher after the original boosters, rising from 184 to 2,829. They were 17 times higher after the updated shots, jumping from 211 to 3,693. After waiting the recommended three months since his last Covid-19 infection, President Joe Biden got an updated booster Tuesday and urged eligible Americans to do the same. Worobey says that when the strains are combined as they are in the updated boosters, they actually end up competing.
CNN —New ads promoting the Covid-19 vaccines are making their debut this week, targeting specific communities that have had a slow uptake of the updated shots. “These ads also reflect our commitment to equity in our COVID response and the need to redouble efforts to reach Black and Hispanic communities about the benefits of the updated vaccines,” she said. We now have updated COVID-19 vaccines to protect you against the Omicron strain.”The new ads, first reported on CNN, will run in 15 US markets, according to HHS. The ads, with a special focus on communities that have historically been underserved, are part of the Biden administration’s effort to encourage people to get their updated vaccine ahead of winter. Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.
WASHINGTON — President Joe Biden will get the updated Covid-19 shot Tuesday after he delivers remarks about the pandemic and the administration’s efforts to get people in the U.S. boosted, a White House official said. It has been more than three months since Biden contracted the coronavirus, which is how long health experts recommend waiting before getting another shot. The White House is focused on reaching those at the highest risk of infection, including senior citizens. Top Biden administration officials have warned in recent weeks about a possible winter surge, particularly as more people head indoors. The White House Covid -19 coordinator, Dr. Ashish Jha, has stressed that timing is also a key factor, pushing people to ideally get their boosters before Halloween to have the best protection possible by the holidays.
Troubling recent reports reveal the emergence of new omicron subvariants that not only evade AstraZeneca’s Evusheld, the antibody drug authorized to prevent Covid infection, but also the sole antibody drug that has retained effectiveness as treatment for Covid, Eli Lilly’s bebtelovimab. Doctors have cautioned that should Laura get Covid, this could aggravate her autoimmune disease and lead to catastrophic kidney damage. Evusheld is a long-acting antibody injection given every six months that studies have suggested provides a robust buffer to the immunosuppressed. For now, immunocompromised people are anxiously watching the pandemic forecast to see if the subvariants that research indicates evade monoclonal antibodies will become predominant. “If fewer people are prescribed Evusheld,” she said, “there’s less incentive for drug companies to start developing newer therapeutics.
CNN —Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, tested positive for Covid-19 Friday. Walensky is experiencing mild symptoms and is up-to-date on her Covid-19 vaccines, according to a statement released by the agency. Walensky received an updated Covid-19 booster in September. The updated Covid-19 booster shots are bivalent, meaning they target the original coronavirus strain as well as the Omicron BA.4/BA.5 subvariants. The booster doses are recommended to given at least two months after the last dose of any Covid-19 vaccine and up to three months after an infection.
Experts say: prepare for more COVID infections this winter. But "among the new variants, XBB has the most significant immune evasion properties," market forecasters at Morgan Stanley said Thursday in a memo. Experts say we should expect many more infections this fall and winter, including infections in vaccinated, boosted Americans. But there are some simple things you can do to prepare to battle XBB and other evasive COVID variants on the horizon. Both have a slight growth advantage over BA.5, which is the dominant version of COVID right now in the US.
Some people are combining the latest COVID booster with this year's flu shot. Initially, Ros had planned to wait to get her flu shot a few weeks later. Several other people told Insider they experienced headaches and nausea after their flu shots and bivalent boosters, even though they hadn't had the same side effects after previous doses of COVID vaccines. The flu shot and bivalent booster packed a punch for some peopleLyn Craven told Insider that she had "little to no reaction" to her latest booster and flu shot, which she scheduled a week apart. Craven said her husband got both the annual flu shot and the bivalent booster on the same day, just like he did last year.
CNN —A flurry of new Covid-19 variants appears to be gaining traction globally, raising fears of a winter surge. As the US moves into the fall, Covid-19 cases are dropping. But virus experts fear that the downward trend may soon reverse itself, thanks to this gaggle of new variants. Lumped together, the variants accounted for almost 1 in 3 new Covid-19 infections nationwide last week, according to the latest estimates from the US Centers for Disease Control and Prevention. The updated bivalent booster vaccines and antiviral drugs like Paxlovid are expected to continue to be protective against severe outcomes from Covid-19 infections caused by the new variants.
Oct 19 (Reuters) - Moderna Inc (MRNA.O) said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months. Omicron-tailored shots by Pfizer Inc (PFE.N) and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron. "Clinical trial data now indicates that the superior immune response produced by our bivalent booster has durability for at least three months," Moderna Chief Executive Officer Stephane Bancel said in a statement. Moderna said it expects data from human trials of its BA.4/BA.5 targeted vaccine later this year.
The authorization of Novavax's booster could significantly increase the role that its shot plays in U.S. vaccination efforts. The Centers for Disease Control and Prevention still has to give the final go ahead before pharmacies can start administering Novavax's booster. Only 35,300 people have received Novavax's shots so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far. People who received Novavax's vaccine as their primary series are also eligible for Pfizer and BioNTech's new omicron booster.
Monkeypox and polio outbreaks, or new COVID-19 variants, have not been “planned” or orchestrated as “scare tactics” to manipulate the Nov. 8 midterm elections in the United States. As laid out in a Reuters explainer (here), experts agree that the major driver behind both vaccine-derived and wild polio outbreaks remains an under-vaccinated population. “Monkeypox is nothing more than a scare tactic to make you stay home and not vote in the November elections. Experts contacted by Reuters dismissed claims that these disease outbreaks are connected to election cycles and said they would not disrupt the upcoming electoral process. There is no evidence that monkeypox and polio outbreaks or new COVID-19 variants have been orchestrated as “scare tactics” to manipulate the U.S. midterm elections.
Fewer than 5% of Americans got an updated Covid-19 shot in the month after the new bivalent boosters rolled out, a comparatively slow start as the Biden administration encourages more Americans to get the vaccine this month. Health authorities have said they are counting on the new Omicron-targeting boosters to protect people during the cold-weather months from hospitalizations and deaths. Yet 7.6 million people in the U.S. got the shots in the four weeks after they were cleared for use, according to the Centers for Disease Control and Prevention.
Dr. Ashish Jha, head of the White House Covid taskforce, said everyone older than 50 and senior citizens in particular need to get an omicron booster as soon as possible. The elderly have faced the high risk of falling seriously ill with Covid since the beginning of the pandemic. Younger people should also get a booster this fall even though they're at lower risk of getting seriously ill from the virus, Jha said. The FDA and CDC rapidly authorized the omicron shots for children as young as 5 years old last week. But the CDC, in a study published last April, said the risk of myocarditis is higher after a Covid infection.
If you already got your omicron-specific Covid booster, you might have experienced some side effects. But there's no need to worry: Experts and new data say the new shots appear to work — regardless of whether you experience moderate, mild or no side effects at all. The new boosters gained approval from the U.S. Food and Drug Administration and the CDC before they finished clinical trials. Like previous Covid vaccines, the new boosters are designed to help you fight the virus by triggering an immune response in your body. Covid vaccines typically take two to three weeks to fully ramp up your immunity, which can help your body stop an infection from happening or keep it from progressing to severe disease.
Side effects of the latest COVID-19 booster are similar to those associated with previous doses. Health officials say it's safe to get your flu shot and COVID booster shot at the same visit. You can get a COVID-19 booster and a flu shot at the same timeThe CDC recommends that everyone over the age of 12 top off their COVID protection with a bivalent booster shot this season, especially if it has been more than two months since their previous dose. With the flu season approaching as well, some people may opt to get their boosters and flu vaccines in one visit. In a press conference in September, White House COVID-19 Response Coordinator Ashish Jha said, "God gave us two arms—one for the flu shot and the other one for the COVID shot."
Covid Vaccines Could Mirror the Flu Shot Process. Here’s What That MeansThe new bivalent vaccine might be the first step in developing annual Covid shots, which could follow a similar process to the one used to update flu vaccines every year. Here’s what that process looks like, and why applying it to Covid could be challenging. Illustration: Ryan Trefes
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