CDC endorses third Pfizer doses for high-risk adults

The Centers for Disease Control and Prevention did on Friday the distribution of Pfizer and BioNTech‘s Covid-19 booster vaccinations for older Americans and other vulnerable people, including those in high-risk professional and institutional settings.

Millions of Americans at the highest risk of Covid can now get a Pfizer BioNTech booster shot to increase their protection.

The Agency’s Advisory Committee on Vaccination Practices had previously unanimously endorsed Pfizer’s third vaccination for people 65 years and over and residents of nursing homes and made further recommendations.

CDC director Dr. However, Rochelle Walensky made a recommendation that the advisory panel rejected. The panel voted against giving a booster vaccination to those ages 18 to 64 who were at higher risk of exposure to the virus because of their work place or institutional setting, but Walensky reintroduced that recommendation.

Here’s what the CDC recommends:

  • Individuals 65 years of age and older and residents in long-term care facilities should receive a booster of Pfizer-BioNTech’s Covid vaccine at least 6 months after their Pfizer BioNTech Primary Series;
  • People between the ages of 50 and 64 with pre-existing conditions should receive a booster vaccination from Pfizer-BioNTech at least 6 months after their Pfizer BioNTech primary series;
  • Individuals aged 18 to 49 with underlying conditions may receive a booster dose of Pfizer BioNTech vaccine for at least 6 months after their Pfizer BioNTech Primary Series, depending on individual benefit and risk;
  • Individuals aged 18 to 64 who are at increased risk of exposure and transmission of Covid-19 due to their professional or institutional environment can, depending on the individual, receive a booster dose of the vaccine for at least 6 months after their Pfizer BioNTech primary vaccination course Pfizer-BioNTech receive benefits and risks.

“I believe that we can best meet the country’s public health needs by providing booster doses to the elderly, those in long-term care facilities, those with underlying medical conditions, and adults at high risk of illness from occupational and institutional exposure to COVID. 19, “said Dr. Walensky.

The move is in line with FDA booster approval, she added.

Earlier Thursday, the CDC advisory panel battled a controversial proposal to boost large swaths of the US population and rejected the plan by 9-6 votes. It would have distributed the shots to nursing home staff, people who live or work in prisons and homeless shelters, frontline health workers, unpaid caregivers, and other key workers like teachers.

“I mean, we might as well say give it to anyone over the age of 18,” said committee member Dr. Pablo Sanchez before voting against the proposal.

Lisa Wilson receives a syringe of the Pfizer vaccine at a mobile COVID-19 vaccination center in Orlando, Florida.

Paul Hennessy | SOPA pictures | LightRakete | Getty Images

Dr. Leana Wen, emergency doctor and former Baltimore health commissioner, called the CDC panel’s vote to reject boosters more generally a “mistake” on Twitter.

“Really, are we not allowing health workers, many of whom were vaccinated back in December, to be boostered? What about teachers in cramped classrooms that don’t require masks? ”She tweeted, adding that CDC Director Dr. Walensky should override the recommendation.

The recommendation goes nowhere near as far as President Joe Biden sought. His government said it plans to give booster shots to people aged 16 and over this week. While the CDC panel’s recommendation doesn’t give the Biden administration everything it wanted, boosters will still be around for millions of Americans who originally received Pfizer’s shots.

Confirmation comes a day after the Food and Drug Administration issued emergency use authorization give many Americans third Pfizer shots six months after completing the first two doses. While the CDC committee’s recommendation is non-binding, Walensky is expected to accept the committee’s approval shortly.

Walensky addressed the committee on Thursday ahead of the vote, thanking them for their work and setting out what is at stake.

“These dates are not perfect, but together they paint a picture for us, and they are what we have right now to make a decision about the next phase of this pandemic,” she said.

Before the vote, some committee members expressed concern that the wide range of boosters on offer could affect efforts to get unvaccinated vaccines or reduce confidence in the vaccines’ effectiveness. Others were frustrated that only Pfizer recipients were eligible for the syringes, leaving millions of Americans out of the picture for receiving the Modern and Johnson & Johnson Vaccinations.

The vote came at the end of a two-day meeting during which CDC advisors listened to several presentations of data to support the widespread adoption of booster vaccinations, including one from a Pfizer executive showing data showing a third Injection appears to be safe and increases antibody levels in recipients.

During a presentation on Thursday, CDC officer Dr. Sara Oliver observational studies from Israel in which officials in front of many other countries began vaccinating the country’s population and offering third vaccinations to their citizens in late July.

The Israeli data has been criticized by at least one FDA official for being based on so-called observational studies, which do not meet the same standards as formal clinical studies.

“We can use Israel’s experience to reinforce our knowledge of booster safety,” Oliver said, adding that the country reported only one case of a rare heart infection known as myocarditis out of nearly 3 million third doses administered .

CDC officer Dr. Kathleen Dooling said the data also suggest a third dose may reduce the risk of serious illness in older adults and people with comorbidities. Possible risks include myocarditis, although this risk is very rare and mostly occurs in men under 30, she said.

“The third dose of the Pfizer-BioNTech Covid-19 vaccine appears to have a similar reactogenicity as the second dose,” she added.

The issue of who and when to get boosters has been a controversial issue in the scientific community since the Biden government outlined its plan last month to distribute them widely.

In published a paper Days before an FDA advisory session last week, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, claimed in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

In the outlines of the plans for last month’s launch Distribute boosters this week, Biden administration officials cited three CDC studies showing that vaccine protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

– CNBC’s Robert Towey contributed to this report.

Fauci defends FDA panel determination to reject third doses for all People

The leading expert on infectious diseases, Dr. Anthony Fauci, responds to allegations made by Senator Rand Paul (R-KY) as he testifies before the Senate Health, Education, Labor, and Pensions Committee on Capitol Hill in Washington, DC on July 20, 2021.

J. Scott Applewhite | Swimming pool | Reuters

Dr. Anthony Fauci defended the Decision of the Board of the Food and Drug Administration refuse to offer a third booster shot PfizerBioNTech Covid-19 vaccine for the general US population.

“I don’t think you made a mistake,” the White House chief medical officer told CNN’s State of the Union on Sunday.

Fauci added that he would support a third dose if future data shows it is effective. As the FDA continues to gather new information about boosters, persuading unvaccinated Americans to get vaccinated remains a priority.

Fauci’s comments come after the FDA advisory committee on Friday Voted against giving third shots of Pfizer’s Covid-19 vaccine to all Americans, although she recommended booster doses for people aged 65 and over and those with underlying medical conditions.

The FDA panel’s decision added to the confusion over the booster dose after President Joe Biden said last month that boosters would be available to all Americans starting the week of September 20th.

“I understand why there might be confusion because I think people have not understood the difference between planning something and actually not understanding what element of it, what portion of it is actually being introduced, and that’s exactly what happened,” he said “Meet the Press” from NBC.

He later told ABC’s This Week that the government had set the September 20 deadline as a wildcard, depending on input from the FDA and the Centers for Disease Control and Prevention.

“The plan was that we have to be ready to do this as soon as a decision is made,” he said. “And when you have a plan, put a date on it and say, ‘We want to be able to prepare for the week of September 20th'” “

Current data from Israel indicates the effectiveness of the vaccine As time decreases, a third shot of Pfizer could restore infection protection to 95% six months after a second dose.

As of September 18, more than 181 million Americans were fully vaccinated. Nationwide, more than 670,000 people have died of Covid-19.

Data on boosters from Modern and Johnson & Johnson is expected in the coming weeks, said Fauci. He also said “This Week” that there will “certainly” be a vaccine for children this fall.

FDA panel recommends Pfizer’s Covid booster doses for individuals 65 and older

An influential advisory committee to the Food and Drug Administration on Friday rejected a proposal to distribute booster vaccinations from Pfizer and BioNTech Covid-19 Vaccine to the general public and scaled back those plans, unanimously recommending the third vaccination to people 65 and older and other at-risk Americans.

“In my opinion it is likely to be beneficial for the elderly and eventually could be indicated for the general population. I just think we’re not there yet in terms of the data, ”said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The panel voted 16-2 against distributing the vaccines to Americans 16 and older before unanimously adopting an alternative plan to give boosters to older Americans and those at high risk of developing serious illness if they got the virus receive. This previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

Pfizer stock closed 1.3% while BioNTech’s shares fell 3.6%.

The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products comes as the Biden government announced that it would begin offering booster vaccinations to the general public as early as next week pending approval from US health regulators . Although the agency has not always followed the advice of its committee, it often does. A final FDA decision could be made in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third syringes in the United States

“We’re not tied to your voice at the FDA just for you to understand. We can adjust this as needed,” recalled Dr. Peter Marks, the agency’s top vaccine regulator, joined the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, such as frontline health workers and other professions exposed to higher levels of exposure to Covid.

It was expected that the committee vote would be controversial, as some scientists included two senior FDA Officials involved in Friday’s meeting said they were not entirely convinced that every American who received the Pfizer vaccine now needs extra doses.

White House senior medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for anyone 16 and older. Fauci, who publicly supported Booster, hesitated in an interview on Friday “Closing bell“To guess what the committee would ultimately decide.

“I don’t want to pre-empt the advisory committee at the time they are deliberating,” he said.

Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.

Allen J. Cockroaches | Los Angeles Times | Getty Images

In published a paper Days before the advisory committee meeting, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists, even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, argued Monday in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

In the outlines of the plans for last month’s launch Distribute booster next week, Biden administration officials cited three CDC studies showing that vaccine protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Before the vote, some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third shot should be limited to specific groups, e.g. illness. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Hayley Gans, a voting member, said she was “concerned” that the FDA asked the committee to review the entirety of the evidence presented Friday because some data, including on safety, were still inadequate.

Another member, Dr. Paul Offit said he would support boosters for people over 60 but struggled to support a third vaccination for younger groups due to a higher risk of myocarditis.

Ahead of Friday’s vote, the committee listened to several presentations on data supporting the widespread use of booster vaccinations, including by health officials in Israel, where officials began vaccinating the country’s population before many other countries and their citizens later July.

Phil Krause, an FDA vaccine regulator and co-author of The Lancet, criticized the results presented Friday, saying that much of the data had not been federally vetted or peer-reviewed. He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In documents released by the FDA on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30, when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. Health officials began to see a trend that people in their 40s and 50s who were fully vaccinated became seriously ill with Covid.

“We didn’t want to wait for these results and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

She also said the booster was well tolerated by many people, citing data showing that out of approximately 2.9 million people who received the additional doses, there was only one case of myocarditis, a rare inflammation of the heart that occurred with mRNA vaccines.

Pfizer’s booster side effects are also similar to those seen after receiving the second dose of vaccine, said Dr. Joohee Lee, an officer with the FDA’s Office of Vaccines Research and Review, during the meeting.

Of the 289 booster recipients, ages 18 to 55 years old, observed in Pfizer’s Phase 3 study, 63.8% developed fatigue, 48.4% headache, and 39.1% muscle pain. The FDA examined side effects in 2,682 recipients of Pfizer’s second dose of Covid aged 16 to 55 years and reported fatigue in 61.5% of patients, headache in 54%, and muscle pain in 39.3%. One adverse event – swelling of the lymph nodes – occurred in 5.2% of booster recipients but only 0.4% of those who received their first two doses.

“The majority were mild to moderate and they resolved,” Lee said of the lymphadenopathy cases. “Though one is reported to be underway right now.”

Fauci says he wouldn’t be shocked if full routine is three doses

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a Senate hearing on Health, Education, Labor and Pensions in the Dirksen Senate office building in Washington, DC, the United States, July 20, 2021.

Stefani Reynolds | Reutesr

The Senior Medical Advisor to the White House, Dr. Anthony Fauci said Thursday he wouldn’t be surprised if the full cycle recommended for that Pfizer and Modern Covid-19 vaccines in the US are vaccinated with three instead of two doses.

Giving an extra dose, or perhaps a final dose, several months after the primary vaccination helps the immune system mature, said Fauci, also the director of the National Institute for Allergies and Infectious Diseases.

“I have to say from my own experience as an immunologist that I would not be at all surprised that the appropriate full vaccination schedule will likely be three doses,” Fauci told reporters during a Covid briefing at the White House.

The infectious diseases expert’s comments come as the Biden government prepares to begin widespread distribution of Covid booster vaccinations in the week of September 20.

The plan, outlined by senior health officials last month, calls for a third dose eight months after the second shot of the Pfizer or Moderna vaccine.

Federal health officials cited three new studies published by the Centers for Disease Control and Prevention, saying vaccine protection against Covid infection decreased several months after receiving the second dose.

Health experts say it’s not uncommon for vaccines to require more than two doses. Vaccinations against hepatitis B and HPV, for example, require a third dose, with several months between the second and third vaccination.

While Americans may need to have a third shot at some point, some health experts have urged officials not to refer to them as “boosters.” That’s because, like other vaccines, Americans may not need any booster vaccinations at a later date.

Fauci said Thursday he would leave it up to the Food and Drug Administration and other regulators to make a decision on the full regimen, but added that it was reasonable to believe that three doses would provide a more permanent immune response.

“If it is stable, you will very likely have a three-dose regimen which is the routine treatment,” he said.

U.S. to start vast distribution of third vaccine doses subsequent month

The United States will begin distributing Covid-19 booster vaccinations on a large scale next month as new data shows vaccine protection wears off over time, US health officials said on Wednesday.

It is now “very clear” that immunity declines after the first two doses, and with the dominance of the delta variant, “we see evidence of decreased protection against mild and moderate disease,” according to the CDC. signed declaration Director Dr. Rochelle Walensky, Acting FDA Commissioner Dr. Janet Woodcock, the White House Senior Medical Advisor, Dr. Anthony Fauci, and other US health leaders.

“Based on our latest assessment, current protection against serious illness, hospitalization and death could decline in the coming months, especially for those at higher risk or who were vaccinated during the earlier stages of vaccination.”

As a result, U.S. authorities are preparing to offer booster shots to all eligible Americans starting the week of September 20, eight months after their second dose of Pfizer or Moderna vaccines, officials said. As they said recipient of Johnson & Johnson‘s single vaccination will likely need a booster vaccination, they are waiting for more dates in the next few weeks before making a formal recommendation.

“With this data, we will also keep the public informed with a timely schedule for J&J booster shots,” officials said.

In a statement late Wednesday, J&J said, “We are working with the US FDA, CDC and other health authorities and will soon be releasing new data on the Johnson & Johnson COVID-19 vaccine refresher.”

The statement added: “In July, Johnson & Johnson shared data showing that our unique COVID-19 vaccine produced strong, sustained immune activity against the rapidly spreading Delta variant and other widely distributed SARS-CoV-2 virus variants. Intermediate results from a Phase 1 / 2a study published in the New England Journal of Medicine also showed that the duration of the immune response was strong and persistent for at least eight months, as long as previously assessed. “

Ensuring long-term and permanent protection against hospitalizations and deaths is critical to containing the COVID-19 pandemic.

The plan is subject to formal recommendation by a CDC Vaccine Advisory Committee and FDA approval, also a formality.

The announcement came ahead of a Covid press conference at the White House on Wednesday, where federal health officials further outlined their plan for boosters.

The booster “will boost your immune response,” President Joe Biden said in a speech at the White House on Wednesday. “It will increase your protection against Covid-19.”

Biden also responded to criticism from some health advocates who say the US should focus on sending vaccine doses to countries with shortages rather than prioritizing booster vaccinations for Americans.

“I disagree,” said Biden. “We can take care of America and help the world at the same time.”

The decision to recommend booster vaccinations comes as the public becomes increasingly concerned about the Delta variant and an increase in breakthrough cases – infections in fully vaccinated individuals. It marks a departure from previous comments by U.S. health officials who said in recent months that fully vaccinated Americans did not need a booster at this point.

U.S. officials changed their embassy to boosters in the past few days as cases continued to rise. Fauci said Thursday that everyone is “likely” to need a booster vaccination Sometime. On Friday, federal officials approved the administration of booster shots to Americans with compromised immune systems, which include cancer and HIV patients, as well as people who have had organ transplants.

The director of the National Institutes of Health, Dr. Francis Collins, who also signed the statement, said Tuesday that new Covid data, including from Israeli health officials, caused US health leaders to rethink their position on vaccination boosters. Israel on Monday released new data showing a reduction in the effectiveness of Pfizer’s Covid vaccine against serious illness in people 65 and over who were fully vaccinated in January or February.

There are similar trends in vaccine effectiveness in the United States, Collins said. He said the surge in breakthrough cases could be due to a combination of the rapidly spreading Delta variant and the deterioration in Covid vaccine protection over time.

The effectiveness of Pfizer’s Covid vaccine is steadily decreasing over time. drops to about 84% for vaccinated people about four to six months after the second dose, according to CEO Albert Bourla. Moderna said his vaccine remained 93% effective in the first six months after the second dose, however, expect protection to wear off and need boosters.

During a news conference on Wednesday, Walensky said officials based their decision on studies showing immunity to Pfizer and Moderna vaccines decreased over several months. A study in New York from May 3 to July 25 showed that the vaccine’s effectiveness in protecting against infection decreased from around 92% to 80%. Another study by the Mayo Clinic showed that the effectiveness of Pfizer’s vaccine decreased from around 76% to 42%, while that of Moderna’s decreased from 86% to 76%.

“Right now, it’s still like our vaccine protection is working really well,” said Collins. “But we don’t want to wait until it’s oh, too late.”

The move to recommend boosters is likely to trigger criticism, especially since a large part of the world population has not even received a dose of a Covid vaccine.

Earlier this month, the World Health Organization urged rich nations to stop distributing booster vaccinations until at least the end of September to allow poorer countries to vaccinate their populations with the first rounds of vaccination. The application is part of WHO Director General Tedros Adhanom Ghebreyesus’ plan to vaccinate 40% of the world’s population by December.

The US released the statement minutes after the WHO condemned wealthy nations who support boosters for the general public.

“We clearly believe that the data so far does not suggest the need for boosters,” said Dr. Soumya Swaminathan, WHO senior scientist, during a press conference. “And we need to know which groups and at what point in time after the vaccination and which specific vaccinations the people received in their basic course.”

Lawrence Gostin, director of the WHO Collaborating Center for National and Global Health Law, called the US booster shot plan “a slap in the face” of the international health agency.

“There is a better way to create a win-win situation,” he said in a telephone interview. “We should only empower our health workers and vulnerable people. At the same time, Biden should undertake a bold campaign to vaccinate the world, including significantly increased donations and an increase in vaccine production. “

“In this way we are doing good to America and good to the world. It is in our national interest to stop the development of even more dangerous varieties,” he added.

During a briefing at the White House Tuesday, press secretary Jen Psaki said the government believes it can empower the American people while ensuring that the rest of the world is vaccinated.

“We believe this is a wrong decision. We can do both,” said Psaki. “The United States is by far the largest contributor to the global fight against Covid. We will continue to be the vaccine arsenal around the world. We also have enough supplies and had planned long enough should a refresher be required for those eligible. “Population.”

Giving third shots appears safe. Early dates from small studies of the effects of booster doses in immunocompromised patients showed no serious side effects from a third shot of an mRNA vaccine, nor did recipients develop side effects beyond those seen after the initial two-dose treatment.

Once the booster is approved, nursing home residents, health care providers and the elderly – the first groups to be vaccinated in December and January – will likely be given priority for additional vaccinations, Collins said Tuesday. He said “ideally” people should stick with the same manufacturer that they got their first two doses from.

“But if for some reason you don’t have access to it, get the other one,” he said. “Again, as a scientist, I would be more comfortable fixing our plans on real dates, and that means sticking to the same type of vaccine that you had to start with.”

– CNBC’s Rich Mendez and Robert Towey contributed to this report.

Africa wants a minimum of 20 million doses within the subsequent six weeks, WHO says

A medical worker injects a dose of the COVID-19 vaccine into a man at a hospital in Accra, capital of Ghana, on May 19, 2021.

Seth | Xinhua News Agency | Getty Images

Africa needs at least 20 million cans AstraZenecas Covid-19 vaccine within the next six weeks to get the second round of shooting for people who have already received the first, the World Health Organization said on Thursday.

The data show that one dose of the AstraZeneca vaccine is 70% effective for at least 12 weeks, but the second dose is 81% protection against Covid for a longer period of time according to the WHO. Antibodies have been seen in the body for up to six months after a dose.

In order for the continent to be able to vaccinate at least 10% of its population by September, another 200 million doses of an approved Covid-19 vaccine are urgently needed, according to the WHO.

As of Thursday, 28 million doses of Covid-19 had been administered in Africa by various drug manufacturers that have nearly 1.4 billion people, which is less than two doses for every 100 people on the continent. By comparison, the U.S. has given more than 165 million doses to nearly half of the U.S. population, according to the Centers for Disease Control and Prevention.

“Africa needs vaccines now. Any break in our vaccination campaigns will result in deaths and a loss of hope,” said Dr. Matshidiso Moeti, WHO Regional Director for Africa. “We urge countries that have vaccinated their high-risk groups to speed up dose distribution to fully protect the most vulnerable.”

France has pledged to share half a million cans with six African countries over the next few weeks and has already sent 31,000 cans to Mauritania. Another 74,400 doses are to be delivered soon, the WHO announced.

The European Union has announced that it will send 100 million doses to low-income countries by the end of 2021, and the United States has pledged 80 million doses. Other countries around the world have also expressed an interest in sharing the doses. Countries in Africa that don’t use all of their cans are also sharing them with other countries on the continent, according to the WHO.

Redistributing vaccine doses is helpful, but expensive. WHO says Africa needs to increase its vaccine production capacity.

“Giving up intellectual property is a critical first step, but it needs to go hand in hand with sharing expertise and critical technologies,” the WHO wrote in a press release.

In Africa, 54 countries are involved in WHO efforts in more than 100 countries to submit a draft resolution to the World Health Assembly. The resolution aims to “strengthen local production, promote technology transfer and innovation and examine the agreement on trade-related aspects of intellectual property rights and intellectual property rights from the point of view of increasing local production,” according to the WHO.

Around 40 African countries have also followed WHO training on building production capacities. The WHO claims to be working with the African Union on a plan to support feasibility studies and technology transfers upon request.

“It’s too early to say if Africa is on the verge of a third wave. We do know, however, that cases are rising and the clock is ticking,” said Moeti.

FDA finds poor circumstances at Baltimore plant that ruined J&J doses

The Food and Drug Administration said Wednesday a facility in Baltimore that ruined millions of Johnson & Johnson Covid-19 vaccine doses was unsanitary and unsuitable for making the shots.

The FDA asked Emergent BioSolutions, which operates the facility, to temporarily suspend production of materials for Covid-19 vaccines earlier this month as the U.S. agency initiated an inspection.

“The company has not adequately trained personnel involved in manufacturing operations, quality control sampling, weighing and dispensing, and engineering operations to prevent drug cross-contamination,” FDA investigators wrote in the report.

The eight-day inspection earlier this month revealed a number of alarming quality issues throughout the facility.

In one 13 page reportInspectors wrote that the facility used to manufacture the vaccine “was not kept in a clean and hygienic condition” and was “not of the appropriate size, design and location to facilitate cleaning, maintenance and proper operation “.

FDA inspectors said paint was peeling in multiple places and walls were damaged, which could affect the facility’s “ability to adequately clean and disinfect.” They also found that when handling waste or materials used to make vaccines, employees did not follow standard operating procedures to ensure they were not contaminated.

The facility has not been approved by the FDA to manufacture or distribute Johnson & Johnson’s Covid-19 vaccine, and none of the doses manufactured at this facility have been marketed for use in the United States. Emergent has agreed to cease production of materials until the issues identified by the FDA are resolved, the agency said.

In a statement, J&J said it had “stepped up its oversight of drug manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure that the quality standards of our company and the US Food & Drug Administration ( FDA) are complied with. “”

“Johnson & Johnson will exercise its regulatory authority to ensure that all FDA observations are promptly and fully considered,” it said.

Emergent said it is determined to work with the FDA and J&J to resolve the issues.

“While we are never satisfied with defects in our production facilities or processes, these can be corrected and we will take quick action to correct them,” it said in a statement.

Robert Califf, former FDA commissioner under the Obama administration, said that while the problems at the Baltimore plant appear “troubling”, manufacturing issues are emerging and one reason FDA oversight is so important.

“Supply chain and manufacturing are really complicated issues, but that’s why you need an FDA and inspections, and it’s the shared responsibility of the FDA and the companies themselves,” he told CNBC in a telephone interview.

At the beginning of this month the Biden administration appointed J&J to manage the Baltimore facility after US officials learned that Emergent, a contract manufacturer, made vaccines for J&J and J&J AstraZeneca, Ingredients mixed for the two shots. Officials also stopped production of the AstraZeneca vaccine.

The stoppage in the production of new materials is the most recent setback for J&J. Last week the FDA and the Centers for Disease Control and Prevention did advised states to stop temporarily J & J’s use of the vaccine “out of caution” after six women developed a rare but potentially life-threatening bleeding disorder in which one was dead and one in critical condition. A key CDC panel is due to meet on Friday to make a recommendation on how to use the vaccine.

The FDA said Wednesday that its actions at the Baltimore facility had nothing to do with the ongoing evaluation of the coagulation cases.

U.S. tops 100 million Covid vaccine doses administered, 13% of adults now absolutely vaccinated

Residents wait in line to be vaccinated on March 10, 2021 in Chicago, Illinois at a COVID-19 mass vaccination center set up in a parking lot outside the United Center, home of the Chicago Bulls and Blackhawks.

Scott Olson | Getty Images

The U.S. exceeded 100 million Covid-19 vaccine doses administered on Friday, according to the Centers for Disease Control and Prevention.

According to the CDC, more than 35 million people have been fully vaccinated, which is 13.5% of the adult US population. About 65.9 million people have received at least one intake of two-dose therapy, the CDC said.

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Biden administration to purchase an extra 100 million doses

Johnson & Johnson’s Janssen COVID-19 vaccine will be stored in Chicago, Illinois for use with United Airlines employees at the United Clinic at O’Hare International Airport on March 9, 2021.

Scott Olson | Getty Images

The US plans to buy an additional 100 million cans of Johnson & JohnsonCovid-19 vaccine, two government sources told NBC News.

president Joe Biden will announce plans on Wednesday during a White House meeting with executives from J&J and Merck.

J&J currently has a contract with the US government to provide 100 million cans by the end of June. The federal government shipped nearly 3.9 million doses of the single vaccine last week and plans to distribute an additional 16 million by the end of this month.

The announcement comes as administration is working to ramp up production of J & J’s vaccine after learning earlier this year that the company was lagging behind in vaccine production.

The Food and Drug Administration approved J & J’s vaccine on February 27 for use in people 18 years of age and older. not how Pfizerand ModernWith J & J’s vaccines, the patient no longer has to return for a second dose and it can be stored at refrigerator temperature for months.

The New York Times first reported in January These unexpected delays in manufacturing would result in reduced first aid supplies of J & J’s medicines if it were given an emergency approval.

Last week, Biden announced This pharmaceutical company Merck would help manufacture J & J’s Covid vaccine. Under the terms of the agreement, Merck will deploy two facilities in the US for J & J’s vaccine. One will make the vaccine and the other will provide “fill-finish” services when the vaccine is put into vials.

The Department of Health and Human Services said the U.S. would provide Merck with $ 105 million under the Defense Production Act to upgrade, upgrade, and equip the company’s facilities to the standards necessary to safely manufacture the vaccine are.

The Chief Medical Officer of the White House, Dr. Anthony Fauci said last month he was “disappointed” with the number of doses J&J originally expected, adding that the federal government had assumed there would be “significantly more”.

“It could be June, July and August before everyone is vaccinated,” Fauci told CNN February 16. “So when you hear how long it will take for the vast majority of the population to be vaccinated, no one will agree that it will be good by the end of summer and that we will get to early fall.”

How CVS and different retailers will dole out any surplus Covid vaccine doses

A health care worker wearing a protective mask fills a syringe with a dose of Pfizer-BioNTech Covid-19 vaccine at a large-scale vaccination site in Sacramento, Calif., On February 4, 2021.

David Paul Morris | Bloomberg | Getty Images

As a Covid-19 vaccination effort at major retailers and pharmacies like begin CVS and WalgreensWhat to do with excess vaccine becomes a bigger question.

Both versions of the vaccine must be stored at very low temperatures. Once thawed, the vaccine must be administered within hours. In addition, vaccine bottles contain multiple doses.

The companies said The Wall Street Journal that they plan to use waiting lists and consider vaccinating employees who are eligible when excess supplies are available. The aim is not to waste any doses that are still tight.

From Thursday, Vaccine doses are sent to thousands of pharmacies and grocery stores like CVS and Walmart in the US This move will start with approximately 6,500 retail locations and will help speed rollout to ensure more Americans are protected Covid-19.

The companies schedule appointments based on the amount of vaccine they receive at each location. However, you could get an excess vaccine if customers don’t show up for an appointment or if a vaccine bottle contains more vaccine than expected.

Currently only two vaccines, one of Pfizer– –BioNTech and another off Modernhave received emergency clearance from the Food and Drug Administration. Both types require two doses of the shot to take effect.

Retailers must adhere to different state and local rules for licensing requirements when managing waiting lists and what to do with excess doses. In some states, retail workers qualify for the vaccine, while in other states they are not considered a high priority group unless they are over a certain age or have a specific illness.

A Walmart spokeswoman told the newspaper that the retailer has reached out to buyers or workers who qualify under a state’s guidelines to get vaccinated in the event of oversupply.

Walmart worked with state health departments on logs to avoid waste, a Walmart spokesman told CNBC. These protocols allow the administration of excess opened and available doses to individuals, including employees, who fall under authorized groups in order of priority.

A Walgreens spokesman told CNBC that they will consider their staff for the remaining doses and will communicate with state and local jurisdictions about any excess doses.

In the meantime, CVS pharmacists will keep a list of qualified patients by state and use that list to determine who will receive the remaining doses of the vaccine, CVS Health senior vice president Chris Cox told CNBC.

Read the full story in the Wall Street Journal.