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CVS stops giving J&J Covid vaccines in pharmacies, nonetheless provides pictures at some MinuteClinics

A nurse will give a syringe to the FEMA-sponsored COVID-19 vaccination site at Valencia State College on the first day the site resumes offering the Johnson & Johnson vaccine.

Paul Hennessy | LightRakete | Getty Images

CVS Health has discontinued Johnson & Johnson’s single-dose Covid-19 vaccine in its pharmacies and only makes vaccinations available in about 10% of its retail locations, the company told CNBC on Wednesday.

The drugstore chain said it made the change in the past few weeks. Customers can still get the syringes at nearly 1,000 MinuteClinic locations in 25 states, and Washington DC MinuteClinics are located in some of the company’s drug stores and provide medical care and other services such as diagnostic tests and vaccines.

CVS pharmacies will continue to offer the two-dose vaccines Pfizer-BioNTech and Moderna Covid nationwide, according to CVS spokesman Mike DeAngelis. He declined to say how many pharmacies were affected by the change, however said it would help with vaccine supply to the drugstore chain.

CVS has more than 9,900 retail locations according to its 2020 annual report.

J&J did not immediately respond to CNBC’s request to comment on the change.

J & J’s vaccine was touted as a blessing by federal health officials when it was approved by the FDA in late February because it only requires one dose and can be stored at refrigerator temperatures for months. Since then, it has suffered from poor public perception of its overall effectiveness, concerns about rare side effects, and production delays.

For some Americans, concerns about the one-shot vaccine have increased with the advent of the Delta variant, which can spread more easily and cause more serious illness than the original coronavirus. Some people have even gone so far as to look for an extra dose not yet recommended by the Centers for Disease Control and Prevention. This week, San Francisco health officials announced they would allow patients who received a J&J vaccine to have a second vaccination from Pfizer-BioNTech or Moderna.

The change by CVS will affect the availability of the recordings for many Americans. J & J’s vaccine is already not getting as much uptake in the US as mRNA vaccines.

According to the CDC, approximately 13.5 million doses of the J&J vaccine had been administered in the US by Tuesday. This compares to a combined total of 333.6 million doses for the vaccine from Pfizer and Moderna.

Dr. Paul Offit, who served on advisory boards for both the CDC and the Food and Drug Administration, said J & J’s vaccine really “suffered” after federal health officials urged states in April to suspend vaccination “as a precaution.” “While examining six women who developed a rare but severe bleeding disorder, said

The recommended break was lifted 10 days later after U.S. officials determined that the benefits of the vaccinations outweigh their risks.

“I think the public is hearing that the vaccine is going off the market for a while and it’s just hard to get past that scarlet letter,” said Offit, also director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

The company and U.S. health officials have claimed the single-use vaccine is safe and highly effective, particularly against serious illness, hospitalizations, and death. J&J reported last month that new research found that its vaccine was effective against the highly contagious Delta even eight months after being vaccinated.

– CNBC’s Nate Rattner contributed to this report.

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J&J Covid vaccine recipients can get supplemental Pfizer or Moderna pictures in San Francisco

People queue at the bulk vaccination booth at the San Francisco Moscone Convention Center, which opened today on February 5, 2021 in San Francisco, California for healthcare workers and people over 65.

Amy Osborne | AFP | Getty Images

The San Francisco Department of Public Health and Zuckerberg San Francisco General Hospital announced Tuesday that they would allow patients who received the single-dose Covid-19 vaccine from Johnson & Johnson to have a second vaccination from Pfizer-BioNTech or Moderna.

J&J recipients can make special requests to get a “supplementary dose” of an mRNA vaccine, city health officials said in a statement to CNBC, declining to call the second shot a “booster.” J & J’s vaccine only requires one dose and recipients are considered fully vaccinated two weeks after receiving the vaccination.

In a call to reporters later Tuesday, San Francisco health officials said they would allow patients to take the extra syringes due to the high number of requests they received from local residents. They claimed that J & J’s vaccine was highly effective against the virus and its variants.

“We have received requests based on patients speaking to their doctors, so we are allowing the placement,” said Naveena Bobba, assistant director of health for the San Francisco Department of Public Health.

Health officials said they do not currently recommend a booster vaccination, which is in line with guidelines from the Centers for Disease Control and Prevention.

“This step does not represent a policy change for the EVS,” says a statement from the health department. “We are still following the guidelines of the Center for Disease Control and Prevention and currently do not recommend a booster vaccination. We will continue to review all new data and adjust our guidelines if necessary. “

The CDC is currently not recommending that Americans mix Covid vaccinations in most cases, and federal health officials say booster doses of the vaccines are not currently required.

The announcement by the San Francisco health authorities comes as some Americans say they are looking for ways to get extra doses of the Covid vaccines – some even go so far as to get extra vaccinations from various companies – due to concerns about the high contagious delta variant.

Dr. Angela Rasmussen, a virologist at Georgetown University, told CNBC last month that she received a booster of Covid-19 vaccine from Pfizer and BioNTech in late June, two months after receiving the single dose from J&J. She was concerned about her level of protection against Delta after studies showed that a single dose of a Covid vaccine was not enough.

Since Rasmussen received her booster, a new study has found that the J&J vaccine against the Delta and Lambda variants is much less effective than against the original virus. The researchers who led the study, which has not yet been peer-reviewed, are now hoping that J&J recipients will eventually receive a booster of the Pfizer or Moderna vaccines.

Of course, the new research contradicts a study by the company that found the vaccine to be effective against Delta even eight months after vaccination, especially against serious illness and hospitalization. It is likely that the mixing and matching debate in the US will rekindle as the highly contagious Delta variant continues to spread in the US

J&J did not immediately respond to a request for comment on the announcement by the San Francisco Department of Public Health.

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Some in Missouri Search Covid-19 Photographs in Secret, Physician Says

Even as the more contagious Delta variant drives a surge in infections, the Covid-19 vaccination effort has become so polarized in Missouri that some people are trying to get shots in secret to avoid conflicts with friends and relatives, a doctor there said.

In a video circulated by her employer, Dr. Priscilla A. Frase, a hospitalist and the chief medical information officer at Ozarks Healthcare in West Plains, Mo., said this month that several people had pleaded for anonymity when they came in to be vaccinated, and that some appeared to have made an effort to disguise themselves.

“I work closely with our pharmacists who are leading our vaccine efforts through our organization,” she said, “and one of them told me the other day that they had several people come in to get vaccinated who have tried to sort of disguise their appearance and even went so far as to say, ‘Please, please please, don’t let anyone know that I got this vaccine.’”

It was not clear how many people had tried to alter their appearance to avoid recognition, or how they had done so. Dr. Frase, who wore a mask in the video, did not immediately respond to a request for comment.

Some people, she said in the video, were “very concerned about how their people that they love, within their family and within their friendship circles and their work circles, are going to react if they found out that they got the vaccine.”

Coronavirus Pandemic and U.S. Life Expectancy

“Nobody should have to feel that kind of pressure to get something that they want, you know,” she added. “We should all be able to be free to do what we want to do, and that includes people who don’t want to get the vaccine as well as people who do want to get the vaccine. But we’ve got to stop ridiculing people that do or don’t want to get the vaccine.”

The video was circulating online as public health officials in Missouri were confronting a resurgent outbreak, driven by the Delta variant and concentrated in the state’s south and southwest.

Updated 

Aug. 1, 2021, 3:54 p.m. ET

The state’s vaccination rate lags that of most other states and the nation as a whole. According to a New York Times database, 41 percent of Missouri residents have been fully vaccinated against Covid-19, compared with more than 49 percent nationwide. In Howell County, Mo., where Ozarks Healthcare and Dr. Frase are based, only 20 percent of residents are fully vaccinated.

On Thursday, Missouri had a seven-day average of nearly 2,500 new cases of Covid-19 — an increase of 39 percent over the previous two weeks. Hospitalizations were up 38 percent over the same period.

Studies suggest that the approved vaccines remain effective against the Delta variant, but public health experts say Delta poses a serious threat to unvaccinated populations.

Understand the State of Vaccine Mandates in the U.S.

Despite that evidence, public health measures to slow the spread of the coronavirus, including vaccinations, have been politicized across much of the country. In some places, including in parts of Missouri, being unvaccinated has become a point of pride for some people. In a Politico report this week, few people who were interviewed at Lake of the Ozarks, a popular tourist destination, acknowledged that they had been vaccinated, and some said that they had been shamed by friends or relatives.

In the video, Dr. Frase said she was particularly troubled by the increased spread of misinformation about the vaccines.

“My fear is that people are getting information from the wrong sources and therefore actually making uninformed decisions rather than informed decisions,” she said.

“I want people to ask medical people,” she added, “or ask somebody that they trust who has good knowledge — not rely on the stuff that’s out there on social media, not rely on people who have opinions not based on facts.”

It was “disheartening,” she said, “to have gotten to that place where we, as health care providers, thought that maybe things were finally back to whatever our new normal is going to be after this pandemic.”

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Covid vaccine charges rise as Individuals rush to get photographs amid delta fears

Nurse Darryl Hana gives a dose of the Pfizer COVID-19 vaccine to a person at a three-day vaccination clinic at the Providence Wilmington Wellness and Activity Center on July 29, 2021 in Wilmington, California.

Mario Tama | Getty Images

The pace of US vaccinations is picking up again as the Delta variant leads to a new surge in coronavirus cases in the US, especially in states with the lowest vaccination rates and worst outbreaks.

Data from the Centers for Disease Control and Prevention shows that nearly 800,000 shots were recorded nationwide on Sunday, the highest total in a day in weeks. The 7-day average of reported vaccinations, including first and second vaccinations, rose by 16% over the past week to 615,000 vaccinations per day (as of Thursday).

The stark contrast in hospital stays and deaths between vaccinated and unvaccinated people has become evident in recent weeks and could convince people on the fence to get the syringes, said Jen Kates, senior vice president of the Kaiser Family Foundation. The overwhelming majority of severe Covid cases – 97% of hospital admissions and 99.5% of Covid deaths – occur in those who are not vaccinated, US health officials say.

“Cases are on the rise and almost everyone who is hospitalized and dies is not vaccinated,” she said. “The data is right there and I think people are realizing that vaccines are our best bet to control this.”

The number of first doses of vaccines has risen faster than the overall rate in the past few days, meaning new people are getting their very first vaccinations. According to the CDC, an average of about 390,000 first doses were given daily for the past seven days, 31% more than a week ago.

“That’s the marker you want to see – the first doses are going up,” Kates said, because it represents new people getting their first shots. This includes people receiving a first vaccination with the two-dose Pfizer or Moderna vaccine, or a single dose of the Johnson & Johnson vaccine.

The pace of daily vaccinations remains far from peak, with more than 3 million daily vaccinations (both doses counted) reported in mid-April. But the upward trend in first doses is encouraging, officials say.

Forty-eight states and the District of Columbia reported increases in average daily first doses compared to the previous week, up from 37 states with increasing first dose rates a week ago.

States with the worst outbreaks see the biggest jumps in vaccination rates, a CNBC analysis of data from the CDC and Johns Hopkins University shows. In the 10 states with the highest average daily new cases per capita, first doses increased 46% week-to-week, significantly higher than the 31% national increase. This group consists of Louisiana, Arkansas, Florida, Mississippi, Missouri, Alabama, Nevada, Oklahoma, Alaska, and Georgia.

“Y’all, we’re going to have a tough couple of weeks,” said Dr. Mississippi state health officer Thomas Dobbs told reporters last week. The state has only fully vaccinated 34.4% of its population, compared to 49.4% of the total US population.

“Delta hits us very hard. We expect we will continue to put additional pressure on the health system, ”he said, noting that there were 13 hospitals across the state with“ zero intensive care beds ”. The breakout there is a strong argument for getting the shots. About 93% of the state’s Covid cases and 89% of deaths in the past month were unvaccinated, he said.

The Delta variant is spreading across the country, causing new spikes in cases, hospitalizations, and deaths, especially in states with poor vaccination records. It is significantly more contagious than the original variety. And unlike the ancestral Covid strain, it is just as easily transmitted from both unvaccinated and fully vaccinated people who have contracted the virus, federal health officials have warned.

Many of the states that have seen dramatic increases in vaccination rates have high community infection rates and low vaccination rates. Louisiana, Mississippi, Alabama, and Georgia are among the top 10 least vaccinated states in the country.

State health officials attribute the rising rates to a combination of factors, including fears of the more contagious Delta variant.

“Last week we doubled the number of people who initiated the vaccine,” said Dr. Joseph Kanter, medical director of the Louisiana Department of Health, told reporters in a call hosted Thursday by the Association of State and Territorial Health Officials. “And this week we are well on the way to double that number again. So we are well on the way to quadruple our vaccination rate within two weeks.”

In Alabama, first doses rose 62% to about 7,400 a day in the past week. It has the fifth lowest vaccination rate in the country among people 12 years and older, while its outbreak, which averages 35 new cases per day per 100,000 population, is the sixth worst in the US

Alabama Health Officer Dr. Karen Landers said concerns about the Delta variant, along with educational efforts and partnerships with local leaders, were the likely reasons for the increased interest in the jab.

“We continue to emphasize the importance of getting vaccinated and we know that the increase in variants, and certainly the delta variant, is more contagious,” she said. “We have the feeling that more and more people understand this need.”

Still, Landers said, misinformation about vaccines is slowing progress. Many people don’t understand the drug approval process and wait for the FDA to give the vaccines full approval before receiving the syringes. Pfizer, Moderna, and Johnson & Johnson vaccines have all been granted temporary emergency approvals and are awaiting final approval.

“We know that many of our employees in Alabama are still not listening to the information we provide regarding scientific evidence,” she said. “We must continue to fight misinformation in our state.”

Conspiracy theories have also run amok and hampered vaccination efforts in neighboring Mississippi, local health officials say.

“We hear everything from the microchip insertion to the depopulation plan, which uses the vaccine to magnetize people. I mean, you name it, we heard it,” said Dr. Dan Edney, chief medical officer for the Mississippi Department of Health, told reporters last week.

An analysis by the Kaiser Family Foundation released in early July shows that the vaccine rate gap between counties that voted for President Joe Biden and former President Donald Trump has widened as the vaccine rolled out, with Democrats much more common report that they were vaccinated Republicans.

Alabama Governor Kay Ivey recently joined Florida Governor Ron DeSantis and former White House press secretary and Arkansas gubernatorial candidate Sarah Huckabee Sanders in a growing chorus of Republican figures who have been voting in recent days asked to be vaccinated.

“It is time to blame the unvaccinated people, not the normal people. It’s the unvaccinated people who are failing us, ”Ivey said last week.

A health care worker at a drive-through location established by Miami-Dade and Nomi Health in Tropical Park prepares to administer a COVID-19 vaccine in Miami, Florida on July 26, 2021.

Joe Raedle | Getty Images

State health officials in Texas, where the proportion of the eligible population with a vaccination is about 5 percentage points below the US level of 66.9%, say the danger of the Delta variant is pushing people to get vaccinated. According to Johns Hopkins data, the state’s average daily case numbers rose 72% over the past week.

“We have seen increases in vaccine doses over the past few weeks,” wrote Chris Van Deusen, director of media relations for the Texas Department of State Health Services, in an email. “We’ve talked a lot about how serious the situation is with the Delta variant as cases and hospitalizations increase, and people seem to get the news.”

California saw a 16% weekly increase in the number of people getting their first dose of vaccine, Governor Gavin Newsom told reporters Monday, including an increase in the vulnerable zip codes “hardest hit by this pandemic”.

“In part because of the Delta and increases in the number of cases and hospital admissions, we are now seeing increased interest in the Covid vaccination in select areas and states,” said Dr. Arthur Reingold, epidemiology director at the University of California, Berkeley.

Officials hope the trend will continue as governments and companies increase pressure on employees and customers to get the shots.

The U.S. Department of Veteran Affairs requires that all health care workers working in Veterans Health Administration facilities be fully vaccinated against Covid vaccinations. Governors in California and New York last week announced plans to mandate vaccines for state employees or to have strict health protocols. Biden put forward a similar federal policy on Thursday, urging governors to offer $ 100 payments to people who receive their first doses of vaccine. Google was one of the first major employers to say it will make vaccines mandatory for anyone who returns to the office this fall.

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Israel to provide Pfizer Covid booster pictures to aged

A man receives his third dose of COVID19 vaccine at Sheba Medical Center on July 14, 2021 in Ramat Gan, Israel.

Amir Levy | Getty Images

Israeli health officials plan to offer booster shots of the Pfizer-BioNTech Covid-19 vaccine to people over age 60 as the shot’s effectiveness appears to wane as the delta variant spreads across the world, NBC News confirmed Thursday.

The heads of health maintenance organizations that have been administering the Pfizer vaccine will begin administering third shots Sunday, according to NBC News. The booster shots are available for patients above 60 who have already received their second shot at least five months earlier.

The country’s Health Ministry reported last week that the two-dose vaccine is now just 39% effective in Israel where the highly transmissible delta variant is the dominant strain. The shot still works very well in preventing people from getting seriously sick, Israeli officials said, demonstrating 88% effectiveness against hospitalization and 91% effectiveness against severe illness.

The data out of Israel, which began vaccinating its population ahead of many other countries, is bolstering arguments from drugmakers that people will eventually need to get booster shots to protect against emerging variants.

Pfizer CEO Albert Bourla on Wednesday doubled down on his comments that people will need a third dose of the vaccine to maintain its high level of protection against the virus. The U.S. drugmaker published new data Wednesday from a company-funded study that showed the vaccine’s efficacy dropped to about 84% after four to six months.

“We have seen also data from Israel that there is a waning of immunity and that starts impacting what used to be what was 100% against hospitalization. Now, after the six-month period, is becoming low 90s and mid-to-high 80s,” Bourla said on CNBC’s “The Exchange.”

The Centers for Disease Control and Prevention, the Food and Drug Administration and the World Health Organization have said they don’t recommend Covid booster shots at this time, citing a lack of data. U.S. and world health officials have said they are looking at the Israeli research, which was not peer-reviewed and was scant on details.

“We have to be mindful that, with time, the effectiveness of these vaccines may wane,” Dr. Isaac Bogoch, an infectious disease professor at the University of Toronto, said in a recent interview.

He stressed that the shots still appear to be highly effective in preventing severe infection, helping hospital systems not get too overwhelmed heading into the colder months. That being said, “we’re still in the Covid era and anything can happen,” he said.

“We have to be prepared and we have to be nimble that people may need a booster at some point,” he added. “This close surveillance that’s happening in countries like Israel, the U.K. and other parts of the world is going to be very helpful in driving policy if and when we do need boosters.

Israel’s plans to boost its population come two days after the CDC reversed course on its prior guidance and recommended fully vaccinated Americans who live in areas with high Covid infection rates begin to wear face masks indoors again. The guidelines cover about two-thirds of the U.S. population, according to a CNBC analysis.

While the delta variant is hitting unvaccinated people the hardest, some vaccinated people could be carrying higher levels of the virus than previously understood and are potentially transmitting it to others, CDC Director Dr. Rochelle Walensky said Tuesday.

Walensky added new data shows the variant behaves “uniquely differently from past strains of the virus,” indicating that some vaccinated people infected with the delta variant “may be contagious and spread the virus to others.”

“This pandemic continues to pose a serious threat to the health of all Americans,” Walensky told reporters on a call. “Today, we have new science related to the delta variant that requires us to update the guidance regarding what you can do when you are fully vaccinated.”

– CNBC’s Kevin Stankiewicz contributed to this report.

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Citing New Knowledge, Pfizer Outlines Case for Booster Photographs

Pfizer reported on Wednesday that the power of its two-dose Covid vaccine wanes slightly over time, but nonetheless offers lasting and robust protection against serious disease. The company suggested that a third shot could improve immunity, but whether boosters will be widely needed is far from settled, the subject of heated debate among scientists.

So far, federal health officials have said boosters for the general population are unnecessary. And experts questioned whether vaccinated people should get more doses when so many people have yet to be immunized at all.

“There’s not enough evidence right now to support that that is somehow the best use of resources,” said Natalie Dean, a biostatistician at Emory University in Atlanta.

Still, the findings raise questions about how well the Pfizer vaccine will prevent infection in the months to come. And with coronavirus cases surging again in many states, the data may influence the Biden administration’s deliberations about delivering boosters for older people.

If third shots are cleared for the general population, the boosters would likely represent a multi-billion-dollar business for Pfizer.

In a study posted online but not yet peer-reviewed or published in a scientific journal, Pfizer and BioNTech scientists reported that the vaccine had a sky-high efficacy rate of about 96 percent against symptomatic Covid-19 for the first two months following the second dose. But the figure declined by about 6 percent every two months after that, falling to 83.7 percent after about four to six months.

Against severe disease, however, the vaccine’s efficacy held steady at about 97 percent.

“This drop is very slight — I wouldn’t say it’s waning,” said Akiko Iwasaki, an immunologist at Yale University. She did not see in the new study any evidence that boosters should go into use for the general population. “These data don’t support a need for that right now,” she said.

The findings fit with what scientists have learned about how the immune system fends off viruses. Antibodies are the only defense to prevent an infection, but their levels typically drop in the months after vaccination or recovery from the disease. If the coronavirus takes hold, immune cells can swoop in to destroy infected cells and make new antibodies.

That enduring defense produced by the vaccine may explain how the virus can sometimes breed in the nose — producing a cold or sore throat — but fail to reach the lung where it can cause serious disease.

“Everything that’s engaged by the vaccine is able to fight off that spread that ultimately leads to severe disease,” Dr. Iwasaki said. “That’s probably not declining at all.”

The study period ended before the rise of the Delta variant, the highly contagious version of the virus that now dominates in the United States and makes vaccines somewhat less effective against infection.

The findings come from 42,000 volunteers in six countries who participated in a clinical trial that Pfizer and BioNTech began last July. Half of the volunteers got the vaccine, while the other half received a placebo. Both groups received two shots spaced three weeks apart.

The researchers compared the number of people in each group who developed symptoms of Covid-19, which was then confirmed by a P.C.R. virus test. When the companies announced their first batch of results, the vaccine showed an efficacy against symptomatic Covid-19 of 95 percent.

Updated 

July 28, 2021, 8:48 p.m. ET

In other words, the risk of getting sick was reduced by 95 percent in the group that got the vaccine, compared with the group that got the placebo. That result — the first for any Covid-19 vaccine — brought an exhilarating dose of hope to the world in December when it was riding what had been the biggest wave of the pandemic.

Since then, the Pfizer-BioNTech vaccine has made up the majority of shots that Americans have received, with more than 191 million doses given so far, according to the Centers for Disease Control.

In the new study, the researchers followed the volunteers for six months after vaccination, up to March 13. Over the entire period, the researchers estimated, the vaccine’s efficacy was 91.5 percent against symptomatic Covid-19. (The study did not measure the rate of asymptomatic virus infections.)

But within that period, efficacy did gradually drop. Between one week and two months after the second dose, the figure was 96.2 percent. In the period from two to four months following vaccination, efficacy fell to 90.1 percent. From four months after vaccination to the March cutoff, the figure was 83.7 percent.

Understand the State of Vaccine Mandates in the U.S.

Those figures still describe a remarkably effective vaccine, however, and may not convince critics that booster shots are widely needed.

The study comes on the heels of data from Israel suggesting that the Pfizer-BioNTech vaccine’s protection may be waning there. But experts have pushed back against a rush to approving a booster there. The data have too many sources of uncertainty, they say, to make a precise estimate of how much effectiveness has waned. For example, the Delta-driven outbreak hit parts of the country with high vaccination rates first and has been hitting other regions later.

“Such an analysis is still highly uncertain,” said Doron Gazit, a physicist at Hebrew University who analyzes Covid-19 trends for the Israeli government.

Earlier on Wednesday, Pfizer reported that a third dose of its vaccine significantly increases blood levels of antibodies against several versions of the virus, including the Delta variant.

Results were similar for antibodies produced against the original virus and the Beta variant, which was first identified in South Africa. Pfizer and BioNTech expect to publish more definitive research in the coming weeks.

The announcement was a preliminary snapshot of data contained in an earnings statement. And although antibody levels are an important measure of immunity, they are not the only metric. The body has other defenses that turn back infection.

Pfizer also said in its statement that vaccines for children ages 5 through 11 years could be available as early as the end of September. The vaccine is already authorized in the United States for everyone ages 12 and up.

Pfizer’s vaccine brought in $7.8 billion in revenue in the last three months, the company said, and is on track to generate more than $33.5 billion this year.

The vaccine is poised to generate more sales in a single year than any previous medical product, and by a wide margin. Pfizer did not disclose its exact profits on the vaccine, but reiterated its previous estimate that its profit margins on the vaccine would be in the high 20 percent range. Even if the drugmaker’s profits fall on the lower end of that range, that would work out to about $3 billion in profit so far this year.

Rebecca Robbins contributed reporting.

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Biden Officers Now Count on Weak People to Want Booster Pictures

WASHINGTON – Biden government health officials increasingly believe that vulnerable populations will need a booster dose even as research continues into how long coronavirus vaccines will remain effective.

Senior officials now say they believe that people over 65 or with compromised immune systems will most likely need a third vaccination from Pfizer-BioNTech or Moderna, two vaccines based on the same technology that were used to vaccinate the vast majority of Americans until now. That’s a significant shift from a few weeks ago when the government said there wasn’t enough evidence to support boosters.

On Thursday, a key official with the Centers for Disease Control and Prevention said the agency is looking into ways to give immune-compromised patients a third dose before regulators expand emergency approval for coronavirus vaccines, a move soon for Pfizer vaccination could be done.

Dr. Amanda Cohn, the chief medical officer of the CDC’s immunization division, told an agency advisory committee that officials are “actively seeking ways” to give certain people access to booster vaccinations “sooner than any possible change in government decisions”.

“So stay tuned,” she added.

The growing consensus within the government that at least some Americans need a booster dose is in part to do with research suggesting that the Pfizer vaccine is less effective against the coronavirus after about six months. More than half of those fully vaccinated in the United States to date have received Pfizer’s vaccine in two doses three weeks apart.

Pfizer’s ongoing global study of its clinical trial participants shows the vaccine’s effectiveness against symptomatic infections drops from a peak of 95 percent to 84 percent four to six months after the second dose, the company said.

Data from the Israeli government, which has fully vaccinated more than half of its population with doses of Pfizer since January, also suggests a downward trend in efficacy over time, though administrative officials view these data cautiously due to the large margin of error.

The latest figures from the Israeli Ministry of Health, released later this week, suggest that Pfizer’s vaccine was only 39 percent effective in preventing infections in the country in late June and early July, compared with 95 percent from January through April.

The vaccine remained more than 90 percent effective in preventing serious illnesses and almost as effective in preventing hospital stays. Israel began offering a third dose of Pfizer to citizens with severely compromised immune systems on July 12th.

Dr. Anthony S. Fauci, who heads the infectious diseases division of the National Institutes of Health, said he was surprised at the apparently steep drop in the effectiveness of the Pfizer vaccine suggested by the Israeli data. He said he wanted to compare it to data the CDC has collected from cohorts of thousands of people in the United States. “People raise their eyebrows a little,” he said.

While other questions abound, senior administrative officials said it was becoming increasingly clear that the vaccines would not provide unlimited immunity to the virus and that at least some people might need booster sessions nine months after their first vaccination. The government has already purchased more than enough vaccine to deliver the third dose of Pfizer and Moderna and has been quietly preparing to step up distribution efforts if necessary.

With so little data left public, many health officials and experts have spoken cautiously about booster vaccinations. Dr. Paul A. Offit, a member of the Food and Drug Administration’s external advisory committee of vaccine experts, said an increase in mild or moderate cases of Covid-19 in people who have been vaccinated does not necessarily mean that a booster is needed.

“The goal of this vaccine is not to prevent mild or mild, moderate infectious diseases,” he said. “The aim is to prevent hospitalization until death. At the moment this vaccine has withstood that. “

Updated

July 23, 2021, 10:06 p.m. ET

An early prospect of a third dose could also act as a deterrent against vaccination, warn other health experts. If Americans feel that immunity to the vaccines is short-lived, they are less likely to get their first vaccination.

“We don’t want people to believe that the vaccines are not effective when you talk about booster vaccinations,” said Dr. Fauci at a hearing before Congress on Tuesday. “You are highly effective.”

Among vaccine manufacturers, Pfizer has been particularly proactive in sharing its data with the government. But the government was stunned by the company’s public announcement earlier this month that it was planning to seek emergency FDA approval for a booster vaccination.

The company said early data from its booster study showed neutralizing antibody levels in clinical trial participants who received a third dose six months after the second was five to 10 times higher than those in recipients who received two doses.

Fearing that the American public would get the wrong news, the FDA and CDC responded with an unusual public statement: “Americans who have been fully vaccinated don’t need a booster right now.” They added, “We are prepared for booster doses, if and when science shows they are needed. “

Ordinarily, the FDA would approve the use of a booster, perhaps after a meeting of its external advisory committee. Then the CDC, which has its own advisory committee, would have to officially recommend it, said Dr. Offit.

Understand the state of vaccine mandates in the United States

But if the FDA fully licensed a vaccine, doctors would have much more leeway to prescribe a booster to their patients. Some health experts believe Pfizer could get this approval by fall this year.

At the CDC advisory board meeting on Thursday, Dr. Cohn, the medical director of the vaccines division, suggested that it might be possible to offer booster shots to people with compromised immune systems through a trial study or other means without waiting for the FDA

Dr. Camille Kotton, an infectious disease expert at Massachusetts General Hospital, told the panel that some patients, especially those who are more educated or “able to look after their own health care,” manage to get a third dose on their own, despite lack of green light from the government.

“Many took matters into their own hands,” she says. “I’m worried they might do this unattended,” she said, while the doctors’ hands are tied due to the lack of regulatory approval.

According to the CDC, people with a weakened immune system make up 2.7 percent of the population and include cancer, organ or stem cell transplants or HIV.

At the Senate Health Committee hearing Tuesday, several senators questioned administration health officials about how quickly they would act on the booster issue. Senator Mitt Romney, a Republican from Utah, said he was unhappy that officials couldn’t come up with a better schedule.

Senator Richard M. Burr, a Republican from North Carolina, noted that Israel is already offering a third chance to some of its most vulnerable citizens. “Why don’t we make the same decisions?” he asked.

Dr. Rochelle Walensky, the director of the CDC, testified that scientists studied the effectiveness of the vaccines in tens of thousands of people, including nursing home residents and more than 5,000 key workers.

“Fortunately, we expect this to wear off, not go down,” she said of her effectiveness. “As we see that fade, we will – this will be our time to act.”

Pfizer is expected to soon publish its clinical studies on immunity declining and the benefits of booster shoots in articles in a peer-reviewed journal. Moderna hasn’t released any data on booster studies, officials said.

Johnson & Johnson’s single-use vaccine has so far played a minor role in the country’s vaccination campaign. Clinical trial data on the mode of action of this two-shot vaccine is expected next month.

Noah Weiland contributed the reporting.

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Some portion of the U.S. inhabitants will get booster photographs, Dr. Scott Gottlieb says

Former Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb said Thursday that Covid booster vaccinations could become a reality for certain segments of the population. Gottlieb made the prediction, following the news, that a panel of expert advisors from the Centers for Disease Control and Prevention is planning to consider booster vaccinations for immunocompromised patients.

“I think the bottom line is that we will strengthen part of the population,” Gottlieb told CNBC’s “The News with Shepard Smith”. “I think it’s something we need to do to consider boosters, especially among the older, more vulnerable populations.”

Gottlieb noted that Israel already offers booster shots to adults with severe pre-existing conditions and that France and the UK are planning to give booster shots. The former FDA chief in the Trump administration also cited data from Israel showing that the shelf life of Covid vaccines does not last as long as researchers would have expected from the start.

“I think we will achieve our goal in terms of boosters, especially for the older population, who were vaccinated in December and January,” said Gottlieb. “You might get a very permanent reaction after the third dose.”

Host Shepard Smith also asked Gottlieb about the reintroduction of mask mandates across the country as a result of the highly transferable Delta variant. Los Angeles County issued a new mask mandate on Thursday that requires residents to wear masks indoors regardless of their vaccination status.

Gottlieb told Smith that he believed Los Angeles was the exception and advised individuals to take masking measures into their own hands.

“I think individuals in these hot spots across the country who are at risk need to take action and take precautions if they think they are at risk, as it is widespread in states that have already done so takes place affirmed that they will not return to mandates, “said Gottlieb.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina.

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Dr. Anthony Fauci says speak of Covid booster photographs does not imply vaccines aren’t working

The Senior Medical Advisor to the White House, Dr. Anthony Fauci told CNBC on Tuesday that Covid booster vaccinations are currently unnecessary.

“The discussion about boosters is really adequate preparation on the part of the [drug] Company are working with the NIH and CDC and others to be prepared in the event you may need a boost, “Fauci said in the Squawk Box.

“But if you translate that into ‘We’re going to need a boost; everyone is going to get a boost’, that’s not appropriate. We still haven’t vaccinated enough people in the main part of it,” he added, emphasizing the booster discussion. ” has absolutely nothing to do with the effectiveness of the vaccine “.

With schools reopening in the fall and the spread of new coronavirus variants, questions are circulating about the need for booster vaccinations, even if the pace of primary vaccinations in the US has slowed since the spring.

On Monday, Pfizer officials met with federal health officials to advocate for the potential need for Covid boosters as the drug company prepares for US approval of a third dose of its current vaccine.

Pfizer announced last week that it is also developing a booster vaccine to combat the highly transmissible Delta variant – now the dominant strain of the virus in the US – and said the immunity was boosted by its Two, developed with German partner BioNTech Shot vaccine wears off.

However, the Centers for Disease Control and Prevention and the Food and Drug Administration released a joint statement blaming Pfizer’s insistence on a third dose, saying that fully vaccinated Americans do not currently need a booster dose.

The officials’ conversation with Pfizer was mostly “a courtesy meeting,” Fauci, director of the National Institute of Allergies and Infectious Diseases, also told CNBC on Tuesday. He said the real question right now is how long protection against the vaccines will last and at what level of protection, a view shared by other health experts.

Former Obama administration official, Dr. Kavita Patel told CNBC on Monday ahead of the Pfizer meeting that booster shots seem like “inevitable” due to newer variations, but questioned when it will happen. She also stressed that when discussing boosters in the US, it is important to take into account the global impact on vaccine adoption in other parts of the world.

Dr. Ashish Jha, dean of Brown University’s School of Public Health, told CNBC on Friday that he had “seen no evidence yet of anyone needing a third injection”.

According to CDC data, the majority of Americans were vaccinated with Pfizer, followed by the two-shot Moderna vaccine and Johnson & Johnson’s single-shot course. More than 184 million people in the United States, or 55.5% of the population, have had at least one injection. Almost 160 million people, or 48% of the population, are fully vaccinated.

Fauci also told CNBC on Tuesday that he would be “amazed” if Pfizer, Moderna and J & J’s coronavirus vaccines don’t get full approval from US drug regulators. These three vaccines are the only ones approved by the FDA in the United States, and they were approved for emergency approval.

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Citing the Delta Variant, Pfizer Will Pursue Booster Pictures and a New Vaccine

Pfizer and BioNTech announced Thursday that they are developing a version of the coronavirus vaccine that will target Delta, a highly contagious variant that has spread to nearly 100 countries. The companies expect to begin clinical trials of the vaccine in August.

Pfizer and BioNTech also reported promising results from studies of people who received a third dose of the original vaccine. A booster shot six months after the second dose of the vaccine increases the effectiveness of the antibodies against the original virus and beta variant by five to ten-fold, the companies say.

The vaccine’s effectiveness could decline six months after immunization, the companies said in a press release, and booster doses may be needed to fight off virus variants.

The data were neither published nor peer-reviewed. The vaccine manufacturers said they expected to submit their results to the Food and Drug Administration in the coming weeks, a step toward approval for booster shots.

But the companies’ claims contradict other research, and several experts dismissed the claim that boosters are needed.

“Given the variants currently circulating, there is really no evidence of a third booster or a third dose of an mRNA vaccine,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “In fact, many of us wonder if you’ll ever need boosters.”

Federal authorities also sounded dubious on Thursday night. In general, Americans who have been fully vaccinated currently do not need a booster vaccination, the FDA and the Centers for Disease Control and Prevention said in a joint statement.

“We are prepared for booster doses when science shows they are needed,” the authorities said.

The Delta variant, first identified in India, is believed to be about 60 percent more contagious than Alpha, the version of the virus that ripped through the UK and much of Europe earlier this year, and perhaps twice as contagious as the original coronavirus.

The delta variant is now causing outbreaks among unvaccinated populations in countries like Malaysia, Portugal, Indonesia and Australia. In the USA, too, Delta is now the dominant variant, the CDC reported this week.

Until recently, infections in the US were at their lowest level since the pandemic began. Hospital stays and deaths related to the virus have continued to decline, but new infections could increase.

It is not yet clear to what extent the variant is responsible for this; A slower vaccination campaign and quick reopenings also play a role.

Citing data from Israel, Pfizer and BioNTech suggest that the effectiveness of their vaccine “in preventing infections and symptomatic illnesses decreased six months after vaccination.” Given the surge in Delta and other variants, the companies said “a third dose may be required within 6 to 12 months of full vaccination”.

Updated

July 11, 2021 at 1:57 p.m. ET

Health officials in Israel have estimated that full vaccination with the Pfizer BioNTech is only 64 percent effective against the Delta variant. (It is more than 90 percent effective against the original virus.)

But Israel’s estimates have been disproved by a number of other studies which found the vaccine to be very effective at preventing infection – against all variants. For example, a recent study showed that mRNA vaccines like those from Pfizer trigger a sustained immune response in the body that can protect against the coronavirus for years.

“Pfizer is looking opportunistic by putting an announcement on the back of very early and undigested data from Israel,” said John Moore, a virologist at Weill Cornell Medicine in New York. “When the time comes to use boosters here, the decision is not up to you.”

The companies described their plan to develop a new vaccine against Delta as a kind of backup measure in case the original vaccine replenishment fails. The new vaccine targets all of the spike protein, not a portion, and the first batch has already been made.

The delta variant poses challenges for the immune system. In the journal Nature on Thursday, French researchers reported new evidence that the delta variant can partially bypass the body’s immune response, as changes to the spike protein on its surface make it difficult for antibodies to attack.

The team analyzed blood samples from 59 people after they received the first and second doses of the vaccine. Blood samples from just 10 percent of those immunized with a dose of the AstraZeneca or Pfizer-BioNTech vaccines were able to neutralize the Delta and Beta variants in laboratory tests.

“A single dose of Pfizer or AstraZeneca was either poorly effective or not effective at all against beta and delta variants,” the researchers concluded. Data from Israel and the UK largely support this finding, although those studies also suggested that one dose of vaccine was still enough to prevent hospitalization or death from the virus.

But a second dose increased the effectiveness to 95 percent. There was not much difference in the levels of antibodies produced by the two vaccines.

“When you receive two doses of an mRNA vaccine, you are very well protected against serious illness, hospitalization and death for each of the variants,” said Dr. Gounder.

The researchers also looked at blood samples from 103 people infected with the coronavirus. Delta was much less sensitive than Alpha to samples from unvaccinated individuals in this group, the study found.

One dose of vaccine increased sensitivity significantly, suggesting that people who have recovered from Covid-19 may still need to be vaccinated to fight off some variants.

Taken together, the results suggest that two doses of the vaccine provide strong protection against all variants, as does one dose for people who have recovered from Covid-19 and have some natural immunity.

Some experts also questioned discussions about boosters for Americans while much of the world has not yet received a single dose.

“It’s impossible to ignore the global situation,” said Natalie Dean, biostatistician at Emory University in Atlanta. “I find it hard to imagine getting a third dose when there are front line workers treating Covid patients who have not yet been vaccinated.”

Every unvaccinated person offers the virus additional opportunities to mutate into dangerous variants, said Dr. Gounder feast.

“If we are concerned about variants,” she said, “our best protection is to get the rest of the world vaccinated, and not to hoard more doses to give people here in the US third doses of mRNA vaccines. “