Tag: Moderna

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Moderna says its shot is 90% efficient 6 months after second dose

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC

A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination facility operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021.

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Moderna’s Covid-19 vaccine was more than 90% effective against Covid and more than 95% effective against serious diseases up to six months after the second dose, the company said Tuesday, referring to updated data from its clinical Phase 3 study.

The update brings Moderna one step closer to filing its application for full US approval for its vaccine. Full approval requires a more rigorous review process to show that the shot is safe and effective for its intended use. With full approval, Moderna can begin marketing the recordings directly to consumers and selling them to individuals and private companies in the United States

The new data included Covid-19 cases through April 9 and assessed over 900 cases, including more than 100 serious cases. The vaccine is currently approved for emergency use by the Food and Drug Administration for those aged 18 and over. The authority can revoke the emergency permit (EUA) at any time. Moderna only submitted safety data to the EEA for two months. The FDA typically takes six months for full approval.

The company said its results are preliminary. Moderna announced that updated data on effectiveness against asymptomatic infections and antibody persistence will be released later this year.

The new data comes from a study published in the New England Journal of Medicine that showed that antibodies induced by the Moderna vaccine were still present six months after the second dose. It also comes after Pfizer said earlier this month that its vaccine, which uses technology similar to Moderna’s, was also shown to be highly effective six months after the second dose.

Dr. Isaac Bogoch, an infectious disease specialist who served on various drug data and safety monitoring boards, described Moderna’s update as “amazing news” and is pleased to hear that both mRNA vaccines are highly effective after six months.

“I think it’s fair to estimate that both will have decent effectiveness over many months,” he said.

Moderna is still evaluating its vaccine in people aged 17 and younger.

The company announced Tuesday that its study testing the vaccine in adolescents ages 12 to 17 is now fully enrolled and has approximately 3,000 participants in the United States

Participants are currently enrolling in his study, which is testing the vaccine in children aged 6 months to 11 years. It is expected that 6,750 healthy pediatric participants will be enrolled in the US and Canada. As in Pfizer’s study, children first receive a low dose of the vaccine before gradually moving on to higher doses.

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Fauci says two photographs of Pfizer or Moderna are higher than one

Fauci says two shots of Pfizer or Moderna are better than one

46-year-old Edith Arangoitia (who came to accompany her older mother) was born on February 16, 2021 by Dr. Galen Harnden in La Colaborativa in Chelsea, Massachusetts, was vaccinated with the Pfizer-BioNTech Covid-19 vaccine.

Joseph Precious | AFP | Getty Images

The Chief Medical Officer of the White House, Dr. Anthony Fauci said Monday that Americans should continue to receive two doses of the Pfizer and Moderna Covid-19 vaccines, although a recent study in the US showed the shots were highly effective after just one dose.

A study by the Centers for Disease Control and Prevention published last week found that a single dose of the Covid-19 vaccine from Pfizer or Moderna was 80% effective in preventing coronavirus infections in healthcare workers and other key workers. Two doses are better than one, federal health officials said, adding that the vaccines’ effectiveness rose to 90% two weeks after the second dose.

While the 80% figure was good news, Fauci said Monday he was still concerned about the length of protection after a single dose, particularly the emergence of highly contagious variants that have shown they can evade the vaccines’ protection .

“If you look at the level of protection after a dose, you can say it’s 80%, but it’s a little weak 80%,” Fauci said during a White House press conference on the pandemic. “If you leave it at one dose, how long will it take?”

Highly infectious Covid-19 variants that have shown some resistance to vaccines also pose a challenge, Fauci said. “You’re in a weak zone if you don’t get the full effect of two doses,” he said.

Fauci’s comments come as some health experts and public health officials argue that the U.S. should prefer to give Americans just one dose of the vaccines before moving on to a second dose, accelerating the pace of vaccinations across the country.

Unlike the Johnson & Johnson vaccine, which requires one dose, the Pfizer and Moderna vaccines require two vaccinations three to four weeks apart. In the UK, health officials decided to increase the time between the first and second dose to 12 weeks to speed up vaccinations.

Fauci has said repeatedly over the past few months that the US should stick to the two-dose regime.

Dr. Paul Offit, a voting member of the FDA’s Vaccines and Related Biological Products Advisory Committee who reviewed both Pfizer and Moderna’s vaccines for emergency approval, told CNBC last week that studies showed immunity after the second dose actually appears to be “more permanent”, meaning that protection can last longer.

The two-dose vaccination schedule also produces ten times the amount of neutralizing antibodies, which play an important role in fighting the virus, from the first dose to the second, Offit told CNBC.

Second, and more importantly, after the second dose, scientists also discovered what are known as T cells, another important part of the immune response that usually provides longer-lasting immunity, he said.

Fauci said Monday he “respects” the case for a one-dose strategy, but added that the US currently has enough doses to provide Americans with the first and second dose. “Although we always stay open, we consider the route we are on to be the best route,” he said.

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CDC examine reveals single dose of Pfizer or Moderna Covid vaccines was 80% efficient

CDC changes Covid vaccine guidance to OK mixing Pfizer and Moderna shots

According to a new study by the Centers for Disease Control and Prevention of vaccinated health care workers, a single dose of the Covid-19 vaccine from Pfizer or Moderna was 80% effective in preventing coronavirus infections.

The effectiveness of the partial immunization was noted two weeks after the first dose, according to the CDC, which studied nearly 4,000 health care workers, first responders and frontline workers between December 14 and March 13, according to other key study staff, which began on Monday had no prior laboratory documentation of the Covid-19 infection.

Two doses are better than one, federal health officials said, adding that the vaccines’ effectiveness rose to 90% two weeks after the second dose.

“These results show that approved mRNA-COVID-19 vaccines in adults of working age effectively prevent SARS-CoV-2 infection under real conditions, regardless of symptom status,” wrote the US agency in the study. “The COVID-19 vaccination is recommended to all entitled persons.”

The new CDC results should back up arguments by some health experts and health officials that the US should give Americans only one dose of vaccines as a priority before moving on to a second dose, accelerating the pace of vaccination across the country.

The CDC results were released just minutes before the press conference by the agency’s director, Dr. Rochelle Walensky, the hospital also released as vaccinations nationwide expedite.

Unlike the Johnson & Johnson vaccine, which requires one dose, the Pfizer and Moderna vaccines require two vaccinations three to four weeks apart. The Chief Medical Officer of the White House, Dr. Anthony Fauci, has said repeatedly over the past few months that the US should stick to the two-dose regime.

Dr. Paul Offit, a voting member of the FDA’s Advisory Committee on Vaccines and Related Biological Products who reviewed both Pfizer’s and Moderna’s vaccines for emergency approval, said the CDC study was overall “good news” .

However, he said he feared people would now think a dose of the vaccines was “good enough” and would not return for a second shot. He said studies have shown that immunity actually appears to be “more permanent” after the second dose, meaning protection may last longer.

“The reason these are two-dose vaccines is because the second dose provides a titer of neutralizing antibodies, virus-specific neutralizing antibodies, that is nearly ten times greater than the first dose,” he told CNBC. Neutralizing antibodies play an important role in the defense of cells against the virus.

Second, and more importantly, scientists have also discovered what are known as T cells, another important part of the immune response that usually lasts longer Immunity, he said.

There are also still questions about the highly contagious variants and whether the vaccines protect mild to moderate forms of the disease, he said.

Of the 3,950 participants in the study, 2,479, or 62.8%, received both recommended doses, and 477, or 12.1%, received only one dose, according to the CDC. The infection rate among the vaccinated participants was 0.04 compared to 1.38 among the non-vaccinated participants.

The study was conducted in eight locations in the United States: Phoenix, Tucson, and other areas in Arizona; Miami, Florida; Duluth, Minnesota; Portland, Oregon; Temple, Texas; and Salt Lake City, Utah. The majority of the participants were female, white, and had no chronic illnesses, according to the CDC.

The study had limitations, the CDC said, adding that delays in deliveries could reduce virus detection sensitivity of Covid-19 tests.

Preliminary real-world vaccine efficacy results for both vaccines complement and expand on estimates of vaccine efficacy from other recent studies, the CDC said. A large study published in the New England Journal of Medicine in February found that Pfizer’s vaccine was 94% effective against symptomatic Covid.

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Moderna Begins Testing Its Covid Vaccine in Infants and Younger Kids

Moderna Starts Testing Its Covid Vaccine in Babies and Young Children

The pharmaceutical company Moderna has started a study testing its Covid vaccine in children under the age of 12, including babies as young as six months, the company said Tuesday.

The study is expected to enroll 6,750 healthy children in the United States and Canada. According to a spokeswoman, Colleen Hussey, Moderna declined to say how many had signed up or received their first recordings.

“There is a great demand for information about vaccination in children and how it works,” said Dr. David Wohl, the medical director of the University of North Carolina Vaccination Clinic, who is not involved in the study.

In a separate study, Moderna is testing its vaccine in 3,000 children ages 12-17 and could have results for that age group by summer. The vaccine would then have to be approved for use in children so that it would not be immediately available.

Many parents want protection for their children, and vaccinating children should help create the herd immunity that is believed to be critical to ending the pandemic. The American Academy of Pediatrics has called for vaccine studies to be expanded to include children.

Vaccine side effects like fever, sore arms, fatigue, and sore joints and muscles can be more intense in children than adults, and doctors say it’s important that parents know what to expect after their children are vaccinated.

Every child in Moderna’s study receives two recordings 28 days apart. The study will consist of two parts. In the first case, children aged 2 to under 12 can receive two doses of 50 or 100 micrograms each. People under the age of 2 may receive two exposures of 25, 50, or 100 micrograms.

Updated

March 21, 2021, 2:25 p.m. ET

In each group, the first children to be vaccinated are given the lowest doses and monitored for reactions before later participants are given higher doses.

Researchers then do an interim analysis to determine which dose is safest and most likely protective for each age group.

Children in Part 2 of the study receive the doses or placebo shots selected by the analysis, which consist of salt water.

Moderna developed its vaccine in collaboration with the National Institute for Allergies and Infectious Diseases. The company and the institute are working together with the Federal Agency for Biomedical Research and Development on the study.

The children will be followed for a year to look for side effects and measure antibody levels, which will allow researchers to determine whether the vaccine appears to offer protection. Antibody levels will be the main indicator, but researchers will also look for coronavirus infections with or without symptoms.

Dr. Wohl said the study was well designed and likely efficient, but asked why the children should only be observed for one year when adults in Moderna’s study were observed for two years. He also said he was a bit surprised that the vaccine was being tested in children so young so soon.

“Should we first learn what happens to the older children before we go to the really young children?” Asked Dr. Well. Most young children don’t get very sick from Covid, although some develop severe inflammatory syndrome that can be life-threatening.

Johnson & Johnson has also announced that it will test its coronavirus vaccine in babies and toddlers after first testing it in older children.

Pfizer-BioNTech is testing its vaccine in children ages 12-15 and plans to switch to younger groups. The product is already approved for use in the USA from the age of 16.

Last month, AstraZeneca began testing its vaccine in the UK in children 6 years and older.

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Moderna Begins Testing Its Covid Vaccine in Infants and Younger Kids.

Moderna Begins Testing Its Covid Vaccine in Babies and Young Children.

The pharmaceutical company Moderna has started a study testing its Covid vaccine in children under the age of 12, including babies as young as six months, the company said Tuesday.

The study is expected to enroll 6,750 healthy children in the United States and Canada.

“There is a great demand for information about vaccination in children and how it works,” said Dr. David Wohl, the medical director of the University of North Carolina Vaccination Clinic, who is not involved in the study.

In a separate study, Moderna is testing its vaccine on 3,000 children aged 12 to 17 years.

Many parents want protection for their children, and vaccinating children should help create the herd immunity that is believed to be critical to ending the pandemic. The American Academy of Pediatrics has called for vaccine studies to be expanded to include children.

Every child in Moderna’s study receives two recordings 28 days apart. The study will consist of two parts. In the first case, children aged 2 to under 12 can receive two doses of 50 or 100 micrograms each. People under the age of 2 may receive two exposures of 25, 50, or 100 micrograms.

In each group, the first children to be vaccinated are given the lowest doses and monitored for reactions before later participants are given higher doses.

The researchers then conduct an interim analysis to determine which dose is the safest and most effective for each age group.

Children in the second part of the study receive the doses or placebo shots selected by the analysis, which consist of salt water.

The children will be followed for a year to look for side effects and measure antibody levels, which will allow researchers to determine if the vaccine is effective. Antibody levels will be the main indicator, but researchers will also look for coronavirus infections with or without symptoms.

Dr. Wohl said the study was well designed and likely efficient, but asked why the children should only be observed for one year when adults in Moderna’s study were observed for two years. He also said he was a bit surprised that the vaccine was being tested in children so young so soon.

“Should we first learn what happens to the older children before we go to the really young children?” Asked Dr. Well. Most young children don’t get very sick from Covid, although some develop severe inflammatory syndrome that can be life-threatening.

Johnson & Johnson has also announced that it will test its coronavirus vaccine in babies and toddlers after first testing it in older children.

Pfizer-BioNTech is testing its vaccine in children ages 12-15 and plans to switch to younger groups. The product is already approved for use in the USA from the age of 16.

Last month, AstraZeneca began testing its vaccine in the UK in children 6 years and older.

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Detroit mayor rejects preliminary J&J vaccine cargo, calls Pfizer, Moderna ‘the very best’

Detroit mayor rejects initial J&J vaccine shipment, calls Pfizer, Moderna 'the best'

Vial of the Janssen Coronavirus Disease (COVID-19) vaccine from Johnson & Johnson

Johnson & Johnson via Reuters

Detroit Mayor Mike Duggan turned down an initial allocation of the Johnson & Johnson Covid-19 single vaccine this week, according to the Michigan State Department of Health.

At a news conference Thursday, Duggan confirmed that he had refused to grant J&J vaccines from the state this week, citing sufficient supply of Pfizer and Moderna vaccines to meet demand from eligible residents.

“Johnson & Johnson is a very good vaccine. Moderna and Pfizer are the best. And I’ll do everything I can to make sure the Detroit city residents get the best,” Duggan said at a news conference Thursday.

The FDA on Saturday approved J & J’s Covid-19 vaccine for emergency use. This makes it the third vaccine approved for distribution in the United States and the only vaccine that requires only one dose.

Clinical trial data shows that J & J’s vaccine provides 66% overall protection against Covid, compared to around 95% for Pfizer and Moderna vaccines. While some have raised concerns about the J&J vaccine’s lower rate of effectiveness, the J&J vaccine has been shown to prevent 100% of virus-related hospitalizations and deaths, according to clinical trial data.

“All vaccines are safe and effective, and I recommend that all vaccines be offered in all communities,” said Dr. Michigan chief medical executive Joneigh Khaldun in a statement to CNBC.

“Also, the Johnson and Johnson vaccine has been studied in a more recent period of time with more easily transmissible variants, so I would not recommend comparing the Pfizer and Moderna studies directly with the Johnson and Johnson studies,” Khaldun said.

At a news conference on Friday, Andy Slavitt, Senior White House Covid Advisor, said Duggan’s comments on the J&J vaccine had been misunderstood.

“We have had a constant dialogue with Mayor Duggan … He is very excited about the Johnson & Johnson vaccine. And I think we want to reiterate the message that the very first vaccine we can take makes perfect sense for all of us is take, “said Slavitt.

In a statement later Friday, Duggan reiterated the effectiveness of the J&J shot in preventing hospitalizations and Covid-related deaths.

“The only reason we decided not to take the first shipment from Johnson & Johnson was because we had the capacity with Moderna and Pfizer to handle the 29,000 first and second dose appointments planned for the coming week which has already brought us very close to our capacity at our current locations, “Duggan said in a statement on Friday.

The J&J allotment, rejected by Duggan, comprised 6,200 doses that were distributed to other local Michigan health departments, according to Bob Wheaton, spokesman for the state health department.

Wheaton said the state doesn’t expect to receive any more J&J vaccines “for a few weeks.”

Duggan said the city will open a new vaccination site for J&J shots if demand from eligible residents exceeds supply of Moderna and Pfizer cans.

“We always planned to distribute Johnson & Johnson as soon as demand warranted it, and we had our distribution plan so we could make it available to our residents as much as Moderna and Pfizer,” Duggan said in Friday’s statement. “By the time the next J&J broadcast arrives, we’ll have our plan to make it available.”

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$100 billion market cap is the blue sky state of affairs for Moderna: analyst

$100 billion market cap is the blue sky scenario for Moderna: analyst

The medic Robert Gilbertson loads a syringe with the vaccine Moderna Covid-19.

APU GOMES | AFP | Getty Images

Biotech and pharmaceutical company Moderna, a pioneer in developing coronavirus vaccines, has the potential to reach a market capitalization of over $ 100 billion, according to an analyst.

When asked what the blue sky scenario could look like for Moderna, whose coronavirus vaccine is 94% effective against severe Covid infections and who is already working on a booster shot to prevent the Hartaj Singh variant, which appears for the first time in South Africa CNBC, managing director and senior biotechnology analyst at Oppenheimer, told CNBC on Thursday that sales trends from similar companies showed what Moderna could see in the future.

“We’re alerting people to other companies in the biotech sector that have peaked or scored a rating when their first line of products was launched. Companies as diverse as Alexion, Regeneron, and Vertex are currently essentially peaking at about ten times future sales, future sales three to five years later. “

“I think with Moderna’s coronavirus vaccine franchise they are also starting to develop flu vaccines that should hit the market in the next few years. You know, we could see a $ 10 billion franchise in five to seven years. If you can If you put ten times the sales multiple and you can do the math, it’s a company with a market capitalization of over $ 100 billion, ”he told CNBC’s Street Signs Europe. The market value is currently just over 57 billion US dollars.

Moderna shares rose 3% in premarket trading on Thursday, as fourth-quarter revenue of $ 571 million far exceeded estimates of $ 318.9 million and was $ 14 million in the fourth quarter of 2019.

Covid-19 vaccine sales were projected to reach $ 18.4 billion in 2021, following $ 199.87 million in sales of Covid-19 vaccines in the fourth quarter. However, the company reported a quarterly stock loss of 69 cents, more than analysts’ forecast loss of 35 cents.

In the income statement, CEO Stephane Bancel said 2020 will be a historic year for Moderna and 2021 will be a “turning point” for the company.

“We used to believe that mRNA would lead to approved drugs, and our ambitions were constrained by the need for regular fundraising and multi-year cash holdings to manage funding risk. We now know that mRNA vaccines can be highly effective and approved and we are a cash flow generating trading company, ‘he said.

“We plan to accelerate and significantly increase our investment in science and expand our development pipeline faster. By implementing our priorities for 2021, we will advance our mission to deliver on the promise of mRNA science, a new generation of transformative drugs for patients This is just the beginning, “he said.

Booster vaccination

The drug maker announced on Wednesday that it would begin testing its new vaccine booster shot, Covid-19, which is said to provide better protection against a new variant of the virus, first discovered in South Africa. The biotech company said it sent cans of the shot to the U.S. National Institute of Health for testing.

Moderna’s current two-dose burst provokes a weaker immune response against the South African strain of the virus, which has been classified as more infectious than other variants, although the company said the antibodies in patients remain above levels expected to be prior to the virus protect.

“Moderna is committed to making as many updates as needed to our vaccine until the pandemic is under control,” Bancel said in a press release. “We hope to show that booster doses can be given at lower doses when needed, which will allow us to make many more doses available to the global community when needed in late 2021 and 2022.”

Separately, the company announced on Wednesday that it is expected to produce up to 700 million doses by 2021 and 1.4 billion Covid-19 vaccine doses by 2022, assuming the vaccine will be administered at its current level of 100 micrograms .

Should the vaccine turn out to be effective at a lower dose, the company could deliver up to 2.8 billion doses in 2022. Moderna has signed a contract with the US government to supply 300 million cans.

Disclaimer: Hartaj Singh does not hold any position in Modernas shares.

– CNBC’s Berkeley Lovelace contributed to this story.

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Moderna strikes ahead to extend Covid vaccine provide in every vial

Moderna moves forward to increase Covid vaccine supply in each vial

A detail of the Moderna COVID-19 vaccine.

Allen J. Cockroaches | Los Angeles Times | Getty Images

Moderna said Monday it had “positive feedback” from the Food and Drug Administration on its proposal to increase the number of Covid-19 vaccine doses in each of its vials.

One vial of Moderna’s two-shot vaccine contains ten doses, enough to vaccinate five people, according to the Centers for Disease Control and Prevention. CNBC reported last month that Moderna had asked the FDA for permission to fill their Covid-19 vaccine bottles with up to five extra doses to remove a manufacturing bottleneck.

In a prepared statement filed ahead of a House hearing on Tuesday, Stephen Hoge, President of Moderna, said the US agency had “given the company positive feedback on our proposal and we are pursuing a plan that will keep the withdrawal up.” allows up to 15 doses from each vial. “

“That way we can produce and deliver more cans faster,” Hoge told the House Energy and Commerce Committee’s Oversight and Investigation Subcommittee. “We will continue to work with our manufacturing partners and the federal government to increase the efficiency of our production process without.” Impairment of quality or safety. “

The announcement comes as President Joe Biden tries to accelerate the pace of vaccinations in the US after a slower-than-expected rollout under former President Donald Trump and states are complaining that they are running out of doses.

Biden announced on Feb. 11 that his government had signed contracts with Pfizer and Moderna for an additional 200 million doses of Covid-19 vaccine, bringing the US number to 600 million. Since both approved vaccines require two doses three to four weeks apart, a total of 600 million doses would be enough to vaccinate 300 million people. The Biden government expects all of this to happen by the end of July.

It is unclear whether Moderna expects to be able to dispense 300 million doses by the end of July due to the increase in the doses per vial.

In December, the FDA announced that healthcare providers could use additional doses from vials of Pfizer’s Covid-19 vaccine. These vials are said to contain five doses, but some vendors have been able to extract a sixth or even a seventh dose. As with Pfizer, some vendors were able to use special syringes to obtain an additional dose of the Moderna vaccine.

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Moderna to start trials of Covid vaccine booster photographs for variant from South Africa

NY will begin offering shots to people with underlying health conditions this month

A health care worker gives a picture of Moderna COVID-19 to a woman at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021 Vaccine.

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Moderna announced on Wednesday that a new Covid-19 vaccine, which is said to offer better protection against the highly contagious variant of coronavirus that is widespread in South Africa, has been delivered to the National Institutes of Health.

The vaccine – which Moderna names mRNA-1273.351 – can be tested in an early clinical trial to see if it can be used as a booster against the South African strain, also known as B.1.351. Moderna has found that its current two-dose regimen produces a weaker immune response against the South African strain, although the company said the antibodies in patients remain above levels expected to protect against the virus.

“Moderna is committed to making as many updates as necessary to our vaccine until the pandemic is under control,” said the company’s CEO, Stephane Bancel, in a press release. “We hope to show that booster doses can be given at lower doses when needed, which will allow us to make many more doses available to the global community when needed in late 2021 and 2022.”

US health officials are increasingly concerned about new, emerging variants of the virus, particularly strain B.1.351, which has been shown to reduce the effectiveness of vaccines both in market and in development. Over the past few weeks, the White House Chief Medical Officer, Dr. Anthony Fauci, urged Americans to get vaccinated as soon as possible before potentially new and even more dangerous variants of the virus emerge.

As of Tuesday, the Centers for Disease Control and Prevention had identified 1,881 cases of variant B.1.1.7, which were first found in the UK. The US authorities said they had identified 46 cases of the strain B.1.351 from South Africa and five cases of P.1, a variant first discovered in Brazil. The more people become infected, the more likely it is that even more problematic mutations will occur, say medical experts.

On Monday, the Food and Drug Administration released updated guidelines that modified Covid-19 vaccines that work to protect against new, emerging variants may be approved without the need for lengthy clinical trials. The FDA would approve the new vaccine as an amendment to a company’s originally approved emergency filing, thereby expediting the regulatory review process.

Moderna first announced on January 25 that it was working on a booster shot to protect itself against the variant in South Africa.

The company announced on Wednesday that it is evaluating three approaches to increasing immunity. The first approach would use variant-specific booster vaccinations such as mRNA-1273.351, but at a lower dose than the original vaccine. The second would combine the original vaccine with a variant-specific vaccine into a single shot at 50 micrograms or less, Moderna said. The third would test a third shot of the original vaccine at a lower dose.

Moderna said it also plans to test the original vaccine and new booster shot as a two-dose regimen in people without coronavirus antibodies.

Separately, the company also announced that it is expected to produce up to 1.4 billion doses of Covid-19 vaccine by 2022. It has also raised its global base production estimate from 600 million cans to 700 million cans this year.

According to Moderna, the 1.4 billion doses in 2022 assume the vaccine will be given at its current level of 100 micrograms. If the vaccine turns out to be effective at a lower dose, the company could deliver up to 2.8 billion doses by 2022, the company said.

Moderna has signed a contract with the US government for 300 million cans. The company has shipped around 55 million cans to the US to date. The first 100 million cans are expected to be shipped to the US by the end of the first quarter of 2021, the second 100 million cans by the end of May 2021, and the third 100 million cans by the end of July 2021.

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Moderna asks FDA to authorize 5 further doses per Covid vaccine vial to hurry distribution, supply tells CNBC

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC

A health care worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination station operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021 .

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Moderna has asked the U.S. Food and Drug Administration for permission to fill their Covid-19 vaccine bottles with up to five additional doses to help clear a manufacturing bottleneck, according to a person familiar with the matter.

The change would allow Moderna to fill 15 cans into vials of the same size, now cleared for 10, which eases the pressure on the manufacturing process known as filling / finishing, said the person who refused to named because the application is not public yet.

The availability of Covid-19 vaccines has caused frustration since their approval in the US in mid-December. While the pace of administration has increased to an average of more than 1 million a day, the limited supply has hampered states’ ability to operate mass vaccination centers. By Friday, the US had distributed 49.2 million doses and 27.9 million had been given, according to the Centers for Disease Control and Prevention.

“We have problems making these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and a physician at Philadelphia Children’s Hospital. “We have up to 1.2 million doses a day when we need 3 million doses a day.”

The FDA declined to comment and asked questions to the company. Moderna did not immediately respond to a request for comment.

The move from Moderna came after Pfizer requested and received a change in emergency approval from the FDA to specify that the Covid-19 vaccine bottles contain six doses instead of five after pharmacists determined that it had a bonus dose the correct syringes could be extracted. Pfizer then said it would ship fewer vials to the US, but the same number of doses specified in its contracts.

Moderna vials have also been found to contain a bonus dose, but a policy change is being sought to add volume to the vials.

The bottleneck is not the vials themselves, but the manufacturing capacity to fill the vials. The manufacturing filling / finishing process must be performed under aseptic conditions to ensure contamination does not occur and the capacity is high.

Companies have begun to form manufacturing partnerships that focus on this step in the process to increase production. Novartis announced on Friday that it has signed an initial vial fill agreement for BioNTech, Pfizer’s partner in Europe, for the Covid-19 vaccine.

“We expect this to be the first in a series of such agreements,” said Steffen Lang, head of technical operations at Novartis.