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U.S. increasing Covid vaccine manufacturing to donate extra doses to world

U.S. expanding Covid vaccine manufacturing to donate more doses to world

The United States is expanding manufacturing of Covid-19 vaccines to donate more doses to countries that don’t have as much access to the lifesaving shots.

“We are now working on greatly expanding the capacity to allow us to donate hundreds and hundreds of millions of doses to the low- and middle-income countries,” Dr. Anthony Fauci, medical advisor to President Joe Biden, said in an interview Thursday on CNBC’s “Closing Bell.”

Scientists around the world, including officials at the World Health Organization, have condemned wealthy nations for administering booster shots to fully vaccinated people while millions in other countries cannot get the vaccine.

Dr. Mike Ryan, director of the WHO’s health emergencies program, said wealthy nations that decide to give booster doses are “handing out extra life jackets” to those who already have one while letting other people drown.

Fauci said the U.S. has given more than 120 million doses to 80 countries and has donated $4 billion in resources to the COVAX vaccine-sharing initiative, which is coordinated by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations and the WHO.

“We are doing both,” Fauci said of distributing booster shots and helping other countries. “We’re very sensitive to the needs of the developing world who need vaccine doses, but we believe we can do both.”

Worries about the delta variant continue to be on the minds of many Americans as health systems in states with high infection rates struggle to keep up with the demand for hospital beds. A continued acceleration of cases could be avoided in the U.S. if more people get vaccinated, Fauci said.

“There’s a lot we can do about it,” Fauci said, noting that 90 million people in the U.S. are eligible for vaccines but still haven’t gotten the shots. “We want to vaccinate the unvaccinated to the highest extent that we possibly can.”

He said it’s hard to know when the current delta outbreak will peak.

“It’s very difficult to predict. We’ve seen in the U.K. that after several weeks of a high acceleration, it’s turned around,” Fauci said.

Once delta infections begin to slow down, Covid could become an endemic disease that remains in the population at low levels, like the flu, though Covid is much deadlier. Fauci said he doubts that Covid — unlike the flu, which requires annual shots — will need recurrent boosters to maintain high levels of protection.

“I don’t think that’s going to be the case. I think this third shot will take us a long way,” Fauci said.

Correction: This article has been updated to reflect that the COVAX vaccine-sharing initiative is coordinated by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations and the WHO.

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

U.S. to begin wide distribution of third vaccine doses next 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. While they said recipients of the Johnson & Johnson single vaccine will likely need booster vaccinations, 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.

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. President Joe Biden is expected to speak about the U.S. efforts after the briefing, the White House told reporters on Tuesday.

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 at some point. 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, had caused US health leaders to reconsider their position on vaccine 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 has steadily declined over time, dropping to around 84% around four to six months after receiving the second dose for vaccinated people, according to CEO Albert Bourla. Moderna said his vaccine remained 93% effective for the first six months after the second dose, but expects protection to decrease and boosts to be needed.

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 data from small studies on the effects of booster doses in immunocompromised patients showed no serious side effects from a third vaccination with an mRNA vaccine, nor did recipients develop side effects beyond those already 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.

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F.D.A. Aiming to Velocity Additional Vaccine Doses for Immunocompromised Sufferers

F.D.A. Aiming to Speed Extra Vaccine Doses for Immunocompromised Patients

The Food and Drug Administration is accelerating efforts to approve additional doses of the coronavirus vaccines for Americans with compromised immune systems, a change that reflects growing concern within the Biden government about these at-risk patients as the contagious Delta variant rises nationwide.

The regulatory move would mean that people with an impaired immune response who need additional vaccination, such as certain cancer patients, could receive legal vaccination. It’s a safer alternative than having patients looking for syringes on their own, as many are doing now, several experts said.

“The data is clear that they did not get a good response initially” and require additional doses, said Dr. Anthony S. Fauci, White House senior medical advisor on the pandemic, in an interview Friday.

Compared to other Americans, “there are much, much more compelling reasons to do this sooner rather than later,” he said.

The benefits of vaccinating these patients can extend well beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more communicable or virulent variants, according to the latest research. Protecting these patients can help prevent variants from occurring.

Officials from the Centers for Disease Control and Prevention and the FDA had been reviewing special programs to give immunocompromised patients additional vaccinations. Now the FDA wants to change the emergency approvals of at least two of the vaccines if data from the CDC supports such a move, according to two people who are aware of the discussions.

The move, expected this month, was first reported by the Washington Post.

Full approval of the Pfizer BioNTech vaccine is expected in early September, maybe even earlier. “If you tell me that full approval is expected by February, I would say that it is a long time for immunocompromised people,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University. “But the next month will bring us a lot of data.”

Dr. At the beginning of the week, Fauci made a distinction between booster vaccinations for people who are fully vaccinated but may have declining immunity, for which the scientific justification is not yet clear, and extra vaccinations for people with weakened immune systems. Research shows that at least some of the latter group require additional doses.

The World Health Organization (WHO) on Thursday condemned the move towards booster vaccinations for fully vaccinated people in rich countries, saying that poor countries urgently need the extra doses. But officials went out of their way to add that this criticism did not apply to additional doses for people with compromised immune systems who may not have been fully protected to begin with.

France has been offering third doses to certain people with weak immune responses since April, and recently Germany and Hungary have followed suit. In many European countries, however, the strategy is not limited to these patients, but also includes, for example, older adults or those who have received vaccines from AstraZeneca or Johnson & Johnson.

In the United States, at least 3 percent of the population is immunocompromised due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or from commonly prescribed drugs such as rituxan, steroids, and methotrexate.

With the rise of the Delta variant, some of these patients and their doctors have begged federal agencies to open a regulatory pathway for the third dose. Although CDC advisors had long appeared to have endorsed the idea, the FDA had not yet done so.

Updated

August 6th, 2021, 4:00 p.m. ET

Older adults and people with certain conditions that suppress the immune system are routinely given extra doses of the influenza and hepatitis B vaccines. This experience provides a good justification for offering extra doses to some older adults and people whose immune responses are subdued, said Dr Balazs Halmos, oncologist at Montefiore Medical Center in the Bronx.

“It makes sense for me to be very proactive,” said Dr. Halmos. “I would like the FDA to take a swift position and possibly pursue these countries on their proactive approach.”

However, other experts are more prudent. Scientists are not yet sure which groups of immunocompromised people will benefit from a third dose.

“I think you can justify both positions,” said Dr. Helen Boucher, an infectious disease doctor at Tufts Medical Center. “Germany is justified, but I also have the feeling that we are entitled to hold back because the information is far from perfect.”

Dr. Boucher says she has empathy for immunocompromised patients. But “the bottom line is we need more information,” she added.

This information has trickled in far too slowly for some Americans.

Deborah Rogow, 70, has multiple myeloma and is concerned about the spread of the contagious Delta variant. Ms. Rogow said it would have been ideal if a doctor would prescribe a third dose if necessary.

Understand the state of vaccine mandates in the United States

She is now alone, so Ms. Rogow plans to have a third dose of the Moderna vaccine at a pharmacy in Santa Barbara, California next week. The Moderna vaccine is still a long way from full approval, she noted, but she didn’t want a Pfizer BioNTech dose without more data on mixing the two vaccines.

“I would have definitely appreciated if I could have told my doctor that it was,” she said. “But it’s a little late.”

Extra doses may help some people with weak immune systems, but others may show little improvement even after a third dose, and still others may not need extra doses at all. In a study of organ transplant recipients, only a third of patients who received a third dose showed a benefit.

“I wish we had a more rational process of identifying people within these categories who actually need it or not,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for a reason. One patient in the transplant study refused her heart after receiving a third dose, said Dr. Segev, who led the research. People with autoimmune diseases can have flare-ups if their immunity is boosted.

“You walk this fine line between wanting to suppress the immune system and having the immune system activated in order to get a good vaccine response,” said Dr. Segev.

There isn’t a lot of long-term data on people who received a third dose either, he noted: “I don’t think there is strong evidence that a third dose is still safe – there is encouraging evidence.”

In the meantime, he suggests that the safest way for people with weak immune systems to get a third dose is to take part in research studies where they can be closely monitored.

The coronavirus persists in some immunocompromised people for much longer than usual and, according to a study published in the New England Journal of Medicine on Thursday, has the potential to make major evolutionary leaps.

Some variants that are now floating around could have originated this way, researchers said, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants.

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Ought to Folks With Immune Issues Get Third Vaccine Doses?

Should People With Immune Problems Get Third Vaccine Doses?

When it came to coronavirus vaccination, the third time was the charm for Esther Jones, a dialysis nurse in rural Oregon. After two doses of the Pfizer-BioNTech vaccine failed to jolt her immune system into producing antibodies, she sought out a third, this time the Moderna shot.

It worked. Blood tests revealed a reasonable antibody response, although lower than what would be detected in healthy people. She received a fourth dose last month in hopes of boosting the levels even more.

Ms. Jones, 45, had a kidney transplant in 2010. To prevent rejection of the organ, she has taken drugs that suppress the immune response ever since. She expected to have trouble responding to a coronavirus vaccine, and enrolled in one of the few studies so far to test the utility of a third dose in people with weak immune systems.

Since April, health care providers in France have routinely given a third dose of a two-dose vaccine to people with certain immune conditions. The number of organ transplant recipients who had antibodies increased to 68 percent four weeks after the third dose from 40 percent after the second dose, one team of French researchers recently reported.

The study in which Ms. Jones enrolled has turned up similar results in 30 organ transplant recipients who procured third doses on their own.

Being vulnerable to infection even after inoculation is “very scary and frustrating” for immunocompromised people, said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University who led the study. “They have to continue to act unvaccinated until we figure out a way to give them better immunity.”

But in the United States, there is no concerted effort by federal agencies or vaccine manufacturers to test this approach, leaving people with low immunity with more questions than answers. The Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health in fact recommend even against testing to find out who is protected. And academic scientists are stymied by the rules that limit access to the vaccines.

“There should be already a national study looking at post-transplant patients getting booster shots,” said Dr. Balazs Halmos, an oncologist at the Montefiore Medical Center in the Bronx, who led a study showing that some cancer patients did not respond to the vaccines. “It shouldn’t be our little team here in the Bronx trying to figure this out.”

An estimated 5 percent of the population is considered to be immunocompromised. The list of causes is long: some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, and drugs like Rituxan, steroids and methotrexate, which are taken by roughly 5 million people for disorders from rheumatoid arthritis and psoriasis to some forms of cancer.

“These are the people being left behind,” said Dr. Jose U. Scher, a rheumatologist at NYU Langone Health who led a study of methotrexate’s effect on the vaccines.

Not everyone who has one of these risk factors is affected. But without more research, it’s impossible to know who might need extra doses of the vaccines, and how many. Besides the risk of Covid-19, there is also evidence that low immunity may allow the virus to continue to replicate in the body for long periods, potentially leading to new variants.

An infusion of monoclonal antibodies may help some people who don’t produce antibodies on their own — but again, the idea is not being thoroughly explored, said John Moore, a virologist at Weill Cornell Medicine in New York.

Use of monoclonal antibodies “makes great sense for this group of people, so I would like to see the companies be more active in this area,” he said. “Government support or pressure would also help.”

Updated 

July 4, 2021, 4:20 p.m. ET

The third-dose approach has widespread support among researchers because there is clear precedent. Immunocompromised people are given booster doses of vaccines for hepatitis B and influenza, for example. And discontinuing methotrexate after getting a flu vaccine is known to improve the vaccine’s potency — evidence that compelled the American College of Rheumatology to recommend pausing methotrexate use for one week before being immunized against the coronavirus.

Several studies have indicated that a third coronavirus vaccine dose might succeed in patients who did not have detectable antibodies after the first or second dose. But research has lagged.

Moderna is gearing up to test a third dose in 120 organ transplant recipients, and Pfizer — which produces some immunosuppressant medications — is planning a study of 180 adults and 180 children with an immune condition.

The companies turned down at least two independent teams who hoped to study the effects of a third dose.

The N.I.H. is recruiting 400 immunocompromised people for a trial that would track their levels of antibodies and immune cells for up to 24 months — but has no trials looking at a third dose.

“It takes time, unfortunately, especially as a government agency,” said Emily Ricotta, an epidemiologist at the National Institute of Allergy and Infectious Diseases. “We have to go through a lot of regulatory and approval processes to do these sorts of projects.”

But that explanation does not satisfy some researchers. Many medical centers already have groups of patients who did not respond to the vaccines, so federal agencies could organize a clinical trial without too much difficulty, Dr. Scher noted. “It’s a very simple study,” he said. “There’s no rocket science here.”

Earlier studies suggested that many people with cancer would not respond to the vaccines, but those analyses were done after the patients had received a single dose. A new study published this month by Dr. Halmos of Montefiore Medical Center and his colleagues laid some of those fears to rest. The vaccines seem to work well in patients with a wide range of solid and liquid tumors, according to the large analysis.

But 15 percent of those who had blood cancers and 30 percent of those who took drugs that suppress the immune system had no detectable antibodies after the second dose. Dr. Halmos said he and his colleagues were eager to test whether a third dose could benefit those individuals, but have not yet been able to gain access to the vaccines.

Dr. Segev’s team found in an earlier study that less than half of 658 organ transplant recipients had measurable antibodies after both doses of an mRNA vaccine made by Pfizer-BioNTech or Moderna. But to follow up on the finding, they had to resort to recruiting volunteers like Ms. Jones who had obtained third doses on their own.

The scientists found that a third dose amped up antibody levels in all 30 organ transplant recipients who had low or undetectable levels of antibodies.

Ms. Jones said many people like her felt they had been abandoned by the federal government — especially with the threat of more contagious variants circulating in the United States.

Some members of a Facebook group for immunocompromised people desperate for protection have gotten a third dose at mass vaccination sites where providers don’t check records, or have even crossed state lines, she said. Even so, most continue to wear masks to protect themselves — and have sometimes had to endure harassment as a result.

“It really saddens me that so many people in this world have made masking like, this super political thing when it should never have been,” she said. “It makes it so it’s harder for us to take care of ourselves.”

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Behind Biden’s Pledge to Share 80 Million Vaccine Doses

Behind Biden’s Pledge to Share 80 Million Vaccine Doses

WASHINGTON – When an airliner carrying 2.5 million doses of the coronavirus vaccine took off from Moderna from Dallas to Islamabad, Pakistan on Wednesday, federal officials had just gone through a dizzying bureaucratic back and forth getting them there.

The United States had a donation agreement with Moderna and Covax, the longstanding vaccine exchange initiative. Covax had previously entered into indemnity agreements with Moderna that protect the company from liability for possible damage caused by the vaccine. Officials at the American embassy in Islamabad had worked with regulators there to assess the Food and Drug Administration’s review of the vaccine; Pakistani regulators had to sift through tons of materials on the vaccine batches and the factory that made them before approving their use there.

Once signed, the result was what is known as a tripartite agreement: a type of agreement that increasingly engages the Biden government’s pandemic response efforts and underscores how the demand for vaccines in the United States is lagging as many countries seek help ask of those who have a surplus.

Amid criticism from some public health experts that President Biden’s vaccine diplomacy has been slow and inadequate, the White House plans to announce Thursday that it has fulfilled the president’s pledge to distribute 80 million doses by June 30 around 50 countries, the African Union and the Caribbean consortium of 20 nations have been officially offered, with around half already delivered and the rest planned in the coming weeks, said Natalie Quillian, the Biden government’s deputy Covid-19 response coordinator .

The dose-sharing effort has become an ongoing activity across the federal government, with alternate-level meetings several times a week and daily operational reviews. The White House can hold up to 15 country-specific calls a day, starting at 7 a.m., often to the National Security Council, Centers for Disease Control and Prevention, the Department of State and Defense, and other agencies.

Approximately 75 percent of the doses are routed through Covax, which has delivered more than 91 million doses to both affluent and low-income countries. The rest is distributed through bilateral agreements that allow countries to retrieve and distribute cans more directly.

Researchers have estimated that 11 billion doses of vaccines are needed worldwide to potentially eradicate the coronavirus pandemic. In the past few months, tens of millions of doses of the three federally approved vaccines in the United States have gone unused, and more have come off the supply lines. White House officials said they wanted to ensure adequate supplies to Americans this spring before completing the overseas shipping overseas work.

To date, more than three billion vaccine doses have been administered worldwide, which is 40 doses per 100 people. Some countries have not yet reported a single dose, although the highly contagious Delta variant is spreading around the world, exposing other inequalities.

“If this is the pace at which it is continuing, then unfortunately it is much slower than necessary,” said Dr. Saad B. Omer, the director of the Yale Institute for Global Health, on the US effort.

Ms. Quillian said more doses would be shipped over the summer, in addition to the 500 million doses of the Pfizer BioNTech vaccine the Biden government promised this month to distribute to about 100 countries next year. She described this phase of vaccination diplomacy as procedurally more complex than the domestic vaccination program. Challenges with bilateral agreements, such as the three million doses of the Johnson & Johnson vaccine sent to Brazil last week, include: the recipient country is negotiating compensation agreements with the manufacturers.

When the cans destined for Pakistan were declared for shipping last week, attention shifted to packaging and transportation to the Dallas airport. The health authorities in Pakistan and an organization behind Covax – UNICEF, the United Nations Children’s Fund – will deliver it, an effort the Biden government wants to oversee. Less than two percent of the Pakistani population are fully vaccinated.

Dr. Hilary D. Marston, a member of the government’s Covid-19 Response Team and a former National Security Council and National Institutes of Health official who helped coordinate supplies, said the State Department and Centers for Control of Disease and Prevention had also worked with Pakistani officials to find out how many doses the country could store.

Pakistan is an obvious candidate for a vaccine donation, Ms. Quillian said. As a neighbor of India, which faced a devastating spike in virus cases this spring, Pakistan has likely been affected by the spread of the Delta variant, which was first identified in India. But the wider list of countries the United States has sent vaccines to required more consideration.

Updated

June 30, 2021, 6:05 p.m. ET

Jake Sullivan, the White House national security adviser, said at a news conference earlier this month that the government was initially prioritizing neighbors of the United States and Asian countries with spikes in virus cases.

The sharing of cans can sometimes appear to be an international matchmaking scheme. Some countries have requested the vaccine from Johnson & Johnson due to simpler storage requirements and its attractiveness as a one shot shot. Others have already approved one or more of the vaccines used in the US, which speeds up the process.

“Any country we offered a vaccine to,” said Ms. Quillian, “if they asked for a specific type, we were able to accommodate that request.”

Officials can still face significant hurdles. Since the donated cans were manufactured and sold according to American legal and official procedures, they must be approved separately by the recipient countries. The process often involves working out kinks with overseas regulators.

The use of Covax doses can sometimes stall, as in South Sudan and Congo, both of which put some of the initiative back due to logistical problems and vaccine reluctance. There have been clearer successes in bilateral agreements that the US has already negotiated. South Korea, which received a million doses of the Johnson & Johnson vaccine from the United States, reported that it used up 99.8 percent of the doses in just a few weeks, White House officials said.

Dr. Omer said that because of the time it takes vaccines to elicit an immune response, targeting donations to countries with outbreaks is insufficient.

“It has been six months, even since the vaccination program started, that we had some substantial movement on this issue,” he said of the dose-sharing campaign.

Ms. Quillian defended the government’s timing. “It’s hard to remember three months, or even February or January. We didn’t have enough vaccine for this country, ”she said. “The president wanted to make sure that we can take care of ourselves first and show that it can work here, and then we always wanted to share when we have surpluses.”

The government of Biden, said Dr. Omer said he needed to rely more on the CDC’s expertise in global vaccination campaigns, including its success in organizing the distribution of polio vaccines.

Dr. Michael H. Merson, professor of global health at Duke University and former director of the World Health Organization’s global program on AIDS, said a useful model for distributing vaccines overseas was the President’s Emergency Plan for AIDS Aid, or Pepfar. who worked with The Global Fund to provide, administer, and monitor the safety of antiretroviral drugs.

The CDC’s disease outbreak prediction operations recently received a financial boost from Mr Biden’s American rescue plan, which would enhance the White House’s efforts to identify potential virus hotspots overseas, White House officials said. A more organized program to do this work is underway, they said.

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Greater than 1 billion doses administered

More than 1 billion doses administered

A medical worker will receive the Covid-19 vaccine on April 7, 2021 at Sun Yat-sen University’s First Affiliated Hospital in Guangzhou, Guangdong Province, China.

Southern image | Visual China Group | Getty Images

GUANGZHOU, China – China has delivered more than a billion doses of its Covid-19 vaccines, a major milestone in the world’s largest vaccination drive.

As of Saturday, 1,100,489,000 doses had been administered to people in China, according to the country’s National Health Commission (NHC). More than 100 million doses were administered in the six days up to and including Saturday.

It is unclear how many people were fully vaccinated as the government does not publish these numbers. But Zhong Nanshan, one of the leading Chinese health experts at the NHC, said in March that the country is aiming to fully vaccinate 40% of the population by the end of June.

After the coronavirus outbreak in China last year, authorities tried to get it under control quickly and largely managed to reopen the economy and get life back to normal. One reason China’s vaccination campaign got off to a slow start earlier this year was because people failed to realize the urgency of vaccination.

But the campaign has now started. It took China 25 days to go from 100 million cans to 200 million cans – and just six days from 800 million to 900 million, according to state media Xinhua.

Still, there were new coronavirus outbreaks in the country last year. Since the end of May, the southern Chinese city of Guangzhou has been fighting against the delta variant that was first created in India. It is the first time this variant has been broadcast locally in mainland China.

The city reported no new locally transmitted cases on Sunday after a mass test drive and local lockdowns.

CNBC two visited vaccination sites in town earlier this month and saw long lines as people rushed to get vaccinated.

The World Health Organization has approved the Chinese-made Sinopharm since May and the Sinovac Covid-19 vaccine since June for emergencies.

China has shipped its vaccines to countries around the world including Brazil, the United Arab Emirates and Malaysia. However, US and European health officials have not approved Chinese emergency vaccines.

There were questions about the effectiveness of the vaccines made in China. The effectiveness rates for China’s Covid vaccines have been found to be lower than those developed by Pfizer-BioNTech and Moderna.

Chile, another recipient of Chinese vaccines, released the results of a real-world study of over 10 million people in April. The Sinovac vaccine was found to reduce deaths by 80%. Despite being one of the most heavily vaccinated countries in the world, Chile saw an increase in cases in April.

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U.S. Is Working to Ship Doses Overseas by Changing AstraZeneca Photographs With Others

U.S. Is Working to Send Doses Abroad by Replacing AstraZeneca Shots With Others

With less than two weeks left to fulfill President Biden’s promise to share 80 million doses of the coronavirus vaccine with countries in need, production problems at an Emergent BioSolutions manufacturing facility are forcing the government to revise its plan to send AstraZeneca doses overseas .

Officials are now working to replace tens of millions of doses of the AstraZeneca vaccine that were originally intended to be included in the donation with others from Pfizer and BioNTech, Moderna and Johnson & Johnson, according to people familiar with the discussions. These three vaccines are approved in the US for emergency use.

A pattern of serious neglect at the Baltimore facility has challenged the fate of more than 100 million doses of AstraZeneca and Johnson & Johnson vaccines manufactured there. The Food and Drug Administration reviews the records of virtually every batch that Emergent has produced to determine if the cans are safe. The FDA has so far decided that approximately 25 million Johnson & Johnson cans made at the factory can be cleared, but has not made a decision on the AstraZeneca cans.

AstraZeneca’s vaccine is significantly cheaper than the other three vaccines: the federal government paid less than $ 4 per dose, compared to up to $ 19.50 for Pfizer. A administration official said that if the AstraZeneca cans produced by Emergent are declared safe, the supply will ultimately be shared with other nations.

The cans the government plans to ship overseas this month will be part of existing orders from other manufacturers that have not yet shipped to states, said a person familiar with the planning. Ten million doses of the three US-approved vaccines that have already been shipped are unused. According to the Centers for Disease Control and Prevention, over 175 million people in the US have received at least one dose.

Until the White House announced last week it would share 500 million doses of the Pfizer vaccine with the rest of the world, the AstraZeneca doses made up the bulk of the government’s vaccine diplomacy.

Mr Biden pledged to share up to 60 million doses of AstraZeneca’s vaccine with other nations in late April pending the ongoing FDA review of Emergent. In May, the White House announced it would send at least another 20 million doses of other vaccines overseas, bringing the total to 80 million by the end of June.

Earlier this month, the White House stated how it would initially distribute 25 million of the 80 million cans across “a wide range of countries.” Millions of these have already been shipped and more will be shipped shortly, a White House spokesman said.

Jeffrey D. Zients, the White House’s Covid-19 response coordinator, said Thursday that 80 million doses would be allocated by the end of the month but did not specify the type. He said the government was working with other countries on complicated logistical issues, including securing needles, syringes and alcohol swabs that would fit the cans.

“We will allot all of the initial 80 million cans in the coming days and shipments will be sent out as soon as countries are ready to receive the cans,” Mr. Zients said at a press conference. “There will be an increasing number of broadcasts each week as we step up these efforts.”

To share vaccines other than AstraZeneca’s, said a person familiar with the plan, the administration will likely need permission from the manufacturers. These discussions are still going on, said the person.

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The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine

The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine

A detail of the Janssen Johnson & Johnson COVID-19 vaccine that is not currently being issued because it has been put on hold.

Allen J. Cockroaches | Los Angeles Times | Getty Images

Federal regulators are forcing Johnson & Johnson to scrap approximately 60 million doses of the Covid-19 vaccine made at a troubled Baltimore facility operated by Emergent BioSolutions due to possible contamination, the New York Times reported on Friday, citing with people familiar with the matter.

The facility closed in April after an inspection revealed several violations, including possible contamination of J & J’s vaccines with a key ingredient from AstraZeneca’s Covid vaccine. About 170 million doses of both vaccines were eligible after the inspection, the Times reported.

The FDA confirmed to CNBC that several lots were not “suitable for use” without confirming the exact number of doses discarded. According to an email statement, the agency announced that it is releasing two batches of vaccine materials made at the facility for use. The Associated Press reported that the two batches would make 10 million cans.

“The FDA has determined that several other lots are unsuitable for use, but additional lots are still being tested and the agency will inform the public of the completion of these tests,” said a statement sent via email.

The US currently has more than enough doses of two other vaccines approved by Pfizer and Moderna to complete vaccination of the American population.

Approximately 10 million doses of the Johnson & Johnson vaccine continue to be distributed in the United States and donated to other countries. The rescued cans will come with a warning stating that federal regulators cannot guarantee that the manufacturing facility operator, Emergent BioSolutions, is following good manufacturing practices, the Times reported.

“Before making this decision, the FDA conducted a thorough review of the facility records and the results of the manufacturer’s quality checks,” the agency said. “Although the FDA is not yet ready to include the Emergent BioSolutions facility in the Janssen EUA as an authorized manufacturing facility, the agency continues to address issues with Janssen and the management of Emergent BioSolutions.”

The Biden government planned to donate more cans of the shots, but those plans were stifled by the investigation of the emergent facility.

The World Health Organization said it would take 11 billion doses worldwide to stop the pandemic from getting worse. The US is buying 500 million doses of Pfizer’s two-shot vaccine to be distributed to countries in need, President Joe Biden is expected to announce at G-7 meetings this weekend.

– CNBC’s Berkeley Lovelace Jr. contributed to this article.

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World News

G-7 leaders to pledge 1 billion doses of Covid vaccines to poorer nations

G-7 leaders to pledge 1 billion doses of Covid vaccines to poorer nations

LONDON – The G-7 leaders are expected to pledge 1 billion doses of coronavirus vaccine to poorer nations this weekend to allay concerns about vaccine nationalism.

The world’s most advanced economies – as the G-7 defines itself – have been criticized for not sharing more vaccines with countries that have fewer resources. For example, the United States has a legal requirement that it cannot send vaccines abroad until it has reached satisfactory levels of vaccination within its borders. The UK and the EU have also received similar criticism.

However, the G-7 countries – the US, UK, Canada, France, Germany, Italy and Japan – want to end the pandemic next year and will increase their individual contributions, according to a statement released by the UK government on Thursday.

The UK already announced on Thursday that it would donate at least 100 million surplus coronavirus vaccine doses within the next year. The United States also announced earlier this week that it would donate 500 million doses of the Pfizer BioNTech shot to low-income countries.

On Thursday, EU Commission President Ursula von der Leyen, who will represent the EU in the G-7, also said: “We are signing the G-7’s goal of ending the pandemic by 2022 through increased global vaccination.”

Sharing vaccines is described by health officials as the only way to end the pandemic completely. Because as long as the virus exists, it can mutate and spread around the world. At the same time, measures like lockdowns and social distancing are likely to continue to affect global economic performance.

According to the Johns Hopkins University, there have been more than 174 million cases of Covid-19 and more than 3.7 million deaths worldwide since the pandemic broke out in early 2020.

The pandemic is at the center of discussions among G-7 leaders, whose three-day summit in Cornwall, England, kicks off on Friday.

In this context, the US surprised other heads of state and government last month by supporting the waiver of intellectual property rights for Covid vaccines.

Health experts, human rights groups and international medical charities argue that this is vital to urgently addressing the global vaccine shortage amid the pandemic and ultimately avoiding a prolongation of the health crisis. However, vaccine makers say this could disrupt the flow of raw materials and result in less investment in health research by smaller biotech innovators.

This opinion is also shared by some EU leaders, in particular French President Emmanuel Macron and German Chancellor Angela Merkel.

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Biden to Ship Thousands and thousands of Pfizer Vaccine Doses to 100 Nations

Biden to Send Millions of Pfizer Vaccine Doses to 100 Countries

WASHINGTON – President Biden, under pressure to aggressively address the global coronavirus vaccine shortage, will announce Thursday that his government will buy 500 million doses of the Pfizer BioNTech vaccine and deliver them to about 100 countries next year The donation will be made by people familiar with the plan.

The White House reached the deal just in time for Mr Biden’s eight-day tour of Europe, which will be his first opportunity to assert the United States as world leader and to re-establish ties that have been badly frayed by President Donald J. Trump.

“We have to end Covid-19, not just at home we do, but everywhere,” Biden told American troops after landing at RAF Mildenhall in Suffolk, England. “There is no wall high enough to protect us from this pandemic or the next biological threat we face, and there will be others. It requires coordinated multilateral action. “

People familiar with the Pfizer deal said the United States would pay for the cans at a “not for profit” price. The first 200 million cans will be distributed by the end of this year, followed by 300 million by next June, they said. The doses will be distributed through Covax, the international vaccine exchange initiative.

Mr Biden is in Europe for a week to attend the NATO and Group of 7 summits and to meet with President Vladimir V. Putin in Geneva. He will likely use the trip to urge other nations to step up vaccine distribution.

In a statement Wednesday, Jeffrey D. Zients, White House official in charge of developing a global vaccination strategy, said Biden will “bring the world’s democracies together to resolve this global crisis, with America leading the way, the vaccine arsenal that will be of vital importance in our global fight against Covid-19. “

The White House is trying to highlight its success in fighting the pandemic – especially its vaccination campaign – and using that success as a diplomatic tool, especially as China and Russia are trying to do the same. Mr Biden has insisted that unlike China and Russia, who share their vaccines with dozens of countries, the United States will not attempt to extort promises from countries that receive US-made vaccines.

The 500 million doses are still well below the 11 billion the World Health Organization estimates to vaccinate the world, but well above what the United States has promised so far. Other nations have asked the United States to give up some of its ample vaccine supplies. In some African countries, less than 1 percent of people are fully vaccinated compared to 42 percent in the United States and the United Kingdom.

Global health advocates welcomed the news but reiterated their stance that it is not enough for the United States to simply give away vaccines. They say the Biden government needs to create the conditions for other countries to manufacture vaccines themselves, including transferring technology to make the cans.

“The world desperately needs new productions to produce billions more doses within a year, not just pledges to buy planned inadequate supplies,” Peter Maybarduk, director of the Citizens’ Access to Medicines Program, said in a Explanation. He added, “We have not yet seen a US government or G7 plan with the ambition or urgency to add billions more doses and end the pandemic.”

The Pfizer deal has the potential to open the door to similar agreements with other vaccine makers, including Moderna, whose vaccine, unlike Pfizer’s, was developed with US taxpayers’ money. In addition, the Biden government has negotiated a deal whereby Merck will help manufacture Johnson & Johnson’s vaccine, and those doses may be available for use overseas.

The United States has already signed a contract to purchase 300 million doses of the Pfizer BioNTech vaccine, which requires two vaccinations to be distributed in the United States; the 500 million cans are on top of that, according to people familiar with the deal.

Biden in Europe

Updated

June 9, 2021, 8:50 p.m. ET

Neither Pfizer nor administrators would tell what the company is charging the government for the cans. Pfizer is also offering the Biden government the option to purchase an additional 200 million cans at cost to be donated overseas.

For Pfizer, the decision to sell so much of the supply to the Biden government for no profit is a significant step.

The vaccine accounted for $ 3.5 billion in sales for the first three months of this year, nearly a quarter of Pfizer’s total sales. By some estimates, the company made approximately $ 900 million in pre-tax income from the vaccine in the first quarter.

However, the company has also been criticized for disproportionately supporting wealthy nations, despite Pfizer’s CEO Albert Bourla promising in January to ensure that “developing countries have equal access to the rest of the world.”

The 200 million Pfizer cans the Biden government plans to donate accounts for about 7 percent of the three billion cans the company is expected to produce this year. Pfizer expects to deliver an additional 800 million doses to lower and lower middle income countries through other agreements with individual countries or Covax, a spokeswoman said.

For Mr Biden, the deal shows that his government is ready to intervene deeper in the treasury to help poorer countries.

Last week, Mr Biden said the United States would be distributing 25 million doses to countries in the Caribbean and Latin America this month; South and Southeast Asia; Africa; and the Palestinian Territories, Gaza and the West Bank.

These cans are the first of 80 million that Mr Biden intended to send abroad by the end of June; three quarters of these are sold by Covax. The rest will be used to address urgent and urgent crises in countries like India, the West Bank and Gaza Strip, government officials said. Many of the 80 million cans were manufactured by AstraZeneca and are still subject to a complex review by the Food and Drug Administration.

Mr Biden has also pledged to support a waiver of an international intellectual property treaty that would make it difficult for companies to refuse their technology. But European leaders are blocking the proposed exemption, and pharmaceutical companies are firmly against it. The World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights Council meets this week to review the derogation.

The president’s promise of vaccines for the world market comes as he prepares on Thursday for a meeting with British Prime Minister Boris Johnson, who has urged leaders to pledge to feed everyone in the world by the end of 2022 vaccinate. Mr Biden’s announcement is likely welcome news to Mr Johnson, whose critics have questioned where the money will come from to keep his promise.

“The truth is, world leaders have been stepping down the street for months – to the point where they ran out of streets,” Edwin Ikhouria, executive director for Africa at ONE Campaign, a nonprofit that dedicated to eradicating global poverty, said in a statement on Wednesday.

About 64 percent of adults in the United States are at least partially vaccinated, and the president’s goal is to increase that number to 70 percent by July 4th, following an accessibility strategy and incentives to reach Americans who have not yet received any injections.

Despite these efforts, there are unused doses of vaccine that could be wasted. Once thawed, cans have a limited shelf life and millions could expire within two weeks, according to federal officials.

Equal access to vaccines has become one of the most persistent challenges in containing the pandemic. Wealthier nations and private corporations have pledged tens of millions of doses and billions of dollars to sustain global supplies, but the disparities in vaccine allocations so far have been stark.

Dr. Tedros Adhanom Ghebreyesus, director general of the World Health Organization, warned this week that the world is facing a “two-pronged pandemic” with countries short of vaccines struggling with virus cases even as better-served countries return to normal.

These lower-income countries will largely depend on wealthier ones until vaccines can be distributed and produced on a more equitable basis, he said.

Daniel E. Slotnik contributed the coverage from New York and Michael D. Shear from Plymouth, England.