Tag: Moderna

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Moderna says it hasn’t discovered a hyperlink between its shot and coronary heart irritation

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

A healthcare worker stops during the coronavirus pandemic (COVID-19) in New York on Jan.

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Moderna has not found a link between its Covid-19 vaccine and the rare heart inflammation cases reported in young people who received the vaccination, the company said on Friday.

The Massachusetts-based biotech said it reached the conclusion after “carefully reviewing the safety data previously available for the Moderna COVID-19 vaccine for cases of myocarditis and / or pericarditis”.

“The company will continue to monitor these reports closely and is actively working with public health and regulators to further evaluate this issue,” said a statement.

A spokesman for the Centers for Disease Control and Prevention did not immediately respond to a request for comment.

A CDC advisory body is organizing on 18.

A CDC official said Thursday that by May 31, the agency had received reports of 275 cases of myocarditis or pericarditis in this age group, up from the 10 to 102 expected cases. The condition includes inflammation of the heart muscle or the lining around it.

“We clearly have an imbalance,” said Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office on Thursday at a meeting of the FDA’s Advisory Committee on Vaccines and Related Biological Products. The group met to discuss safety issues related to the use of Covid-19 vaccines in children 6 months and older.

The CDC’s vaccine safety group said last month it is studying heart infections in “relatively few” people who have received Covid vaccinations. Officials say they still don’t know if the condition is really related to the vaccines.

Some of the reported cases could be something other than myocarditis or pericarditis upon further investigation, Shimabukuro said Thursday.

Men make up the majority of reported cases and most cases appear to be mild, officials say. Of the 270 people who developed the disease and were discharged, 81% made a full recovery, according to a CDC presentation at Thursday’s meeting. By May 31, 15 people had been hospitalized, three of them in intensive care, the agency said.

Although no link has been found between the vaccines and the disease, health experts say side effects occur rarely once a vaccine or drug is administered to the general population. The US has distributed millions of Covid vaccines which have helped contain new cases and hospital stays across the country.

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Moderna Apples for Authorization of Its Covid Vaccine for Adolescents

Moderna Apples for Authorization of Its Covid Vaccine for Adolescents

Moderna applied to the Food and Drug Administration on Thursday for emergency clearance to use its coronavirus vaccine in 12-17 year olds. If approved as expected, the vaccine would offer a second option to protect teenagers from the coronavirus and speed the return to normal for middle and high school students.

The company has already applied for approval from Health Canada and the European Medicines Agency and plans to apply for approval in other countries, CEO Stéphane Bancel said in a statement. FDA approval usually takes three to four weeks.

Last month, the FDA expanded the emergency approval of Pfizer and BioNTech’s vaccine for use in children ages 12-15. This vaccine was already available to anyone over the age of 16. About 7 million children under the age of 18 have received at least one dose of the vaccine to date, and about 3.5 million are fully protected.

Moderna’s vaccine was approved for use in adults in December. His application to the FDA for young teenagers is based on study results published last month. This clinical trial enrolled 3,732 children, ages 12-17, with 2,500 receiving two doses of the vaccine and the remainder receiving a saltwater placebo.

The study found no cases of symptomatic Covid-19 in fully vaccinated adolescents, which is 100 percent effectiveness, the same number that Pfizer and BioNTech reported for this age group. The study also found that a single dose of the Moderna vaccine was 93 percent effective. Participants did not experience any serious side effects beyond those seen in adults: injection site pain, headache, fatigue, muscle pain, and chills.

An independent safety monitoring committee will follow all participants for 12 months after their second injection to assess long-term protection and safety.

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Moderna Seeks Full F.D.A. Approval for Covid Vaccine

Moderna Seeks Full F.D.A. Approval for Covid Vaccine

Moderna was the next pharmaceutical company to file with the U.S. Food and Drug Administration on Tuesday for full approval of its coronavirus vaccine for use in people aged 18 and over.

Last month Pfizer and BioNTech filed with the agency for full approval of their vaccines for use in people 16 years and older.

“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the ongoing filing,” said Stéphane Bancel, CEO of Moderna, in a statement.

Moderna’s emergency vaccine was approved in December, and by Sunday more than 151 million doses had been administered in the United States, according to the Centers for Disease Control and Prevention.

“I think there are a lot of people on the fence who are worried that things are moving too fast and about possible side effects,” said Dr. William Schaffner, National Foundation for Infectious Diseases medical director and vaccine expert. “But those concerns are allayed as they see more of their friends and acquaintances celebrating their vaccination.”

Jan Hoffman contributed to the coverage.

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Moderna applies for full FDA approval

Moderna applies for full FDA approval

A medical worker from Parrish Medical Center holds a vial of the Moderna COVID-19 vaccine at a drive through vaccination clinic for employees of Port Canaveral, workers at local hotels and restaurants, and residents of the Port Canaveral community.

Paul Hennessy | LightRocket | Getty Images

Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the shots directly to consumers.

The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of data. Over 100 million of the shots have already been administered, according to data compiled by the Centers for Disease Control and Prevention.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

The FDA approval process is likely to take months.

Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks, the company said Tuesday.

Once companies submit applications to the FDA, agency scientists painstakingly look through the clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “They want to make sure that the company has fairly and accurately displayed all those data,” he said.

Full U.S. approval will allow Moderna’s vaccine to stay on the market once the pandemic is over and the U.S. is no longer in a public health emergency, said former FDA commissioner Dr. Robert Califf. It also sets the stage for the company to begin advertising the shots on TV and other media platforms, he said, which is not permitted under an EUA.

Moderna is the second company to seek full U.S. approval of its Covid vaccine. On May 7, Pfizer and partner BioNTech said they started the process of seeking full approval for their vaccine for use in people 16 and older in the U.S.

Moderna’s vaccine, which requires two doses given four weeks apart, has been found to be more than 90% effective at protecting against Covid and more than 95% effective against severe disease up to six months after the second dose. The company said in an earnings report on May 6 that it planned to begin the process of seeking full FDA approval soon.

In addition to seeking full approval, the company is also expected to ask the FDA to expand the emergency use of its Covid vaccine for adolescents as young as 17. The company said last week its shots were found to be 100% effective in a study of kids ages 12 to 17.

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Moderna Vaccine Extremely Efficient in Adolescents, Firm Says

Moderna Vaccine Highly Effective in Adolescents, Company Says

The authorization of a second vaccine for adolescents could help convince more parents, some of whom have expressed reluctance about having their children vaccinated, that the shots are safe, experts said. “Most parents vaccinate their children,” Dr. O’Leary said. “With the Covid vaccines, we’ve seen a little bit more hesitancy, but the further along we get demonstrating safety and effectiveness, the more people we’re seeing wanting the vaccine.”

It would also give parents and teenagers a choice between vaccines, although experts noted that the Pfizer and Moderna vaccines appear to be equally safe and effective.

“This really give parents, I think, a little bit more confidence,” said Rupali Limaye, an expert on vaccine use and hesitancy at Johns Hopkins University. “If they’ve had personal experience, for example, with one of the mRNA products and not the other, they might feel more comfortable then saying, ‘You know, I had a great experience with Moderna, so I really want my child to get Moderna.’”

But because the Pfizer and Moderna vaccines both require two shots, spaced several weeks apart, ensuring that all teens have access to the vaccine may remain a challenge. “I think we’ll still unfortunately not be able to reach more underserved populations that are facing vaccine disparities, because it’s still the two-dose regimen,” Dr. Limaye said. Authorizing a one-dose vaccine, like the Johnson & Johnson shot, for use in adolescents may help close these gaps, she said.

The U.S. already has enough doses to vaccinate adolescents many times over. There are approximately 25 million American children between the ages of 12 and 17, according to estimates from the U.S. Census Bureau. That is roughly the same number of shots that Pfizer and Moderna are distributing, in total, per week in the U.S.

“Right now, we have more than enough supply to vaccinate our teens,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “So it’s not so much that the Moderna vaccine is critical for having supply for our population, but rather, having a second vaccine come online for that age group that could be available to the rest of the world — I think that is important.”

Many other countries, however, will not be ready to vaccinate their adolescents for quite some time. Although more than 1.7 billion vaccine doses have been administered globally, there are enormous inequities between countries; 84 percent of doses have gone to people in high- and upper-middle-income countries. Just 0.3 percent have gone to low-income countries.

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Moderna says shot is 100% efficient in teenagers, plans to hunt FDA OK in June

Moderna says shot is 100% effective in teens, plans to seek FDA OK in June

A young man receives his Covid-19 vaccination in a vaccination clinic. People are receiving the Moderna vaccine in Milford, Pennsylvania.

Preston Ehrler | LightRocket | Getty Images

Moderna said Tuesday that its Covid-19 vaccine was 100% effective in a study in adolescents ages 12 to 17. This makes it the second attempt after Pfizer that has demonstrated a high level of effectiveness in younger age groups.

The company plans to ask the Food and Drug Administration to expand emergency use of its Covid-19 vaccine to teenagers early next month. If approved, it would likely dramatically increase the number of recordings available to middle and high school students before the next school year. Pfizer and German partner BioNTech were approved to use their vaccine for 12 to 15 year olds earlier this month.

“We are encouraged that mRNA-1273 is highly effective in preventing COVID-19 in adolescents,” said Stephane Bancel, CEO of Moderna, in a press release. “We continue to strive to do our part to end the COVID-19 pandemic.”

The two-dose vaccine, given four weeks apart, is already approved for adults.

The phase 2/3 study the company cited on Tuesday included more than 3,700 teenagers. No cases of Covid-19 were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, according to the company.

No significant safety concerns have been identified to date, with side effects generally in line with a previous study in adults, the company said. The most common side effects after the second dose were headache, fatigue, muscle pain, and chills, Moderna said.

The new data comes less than three weeks after the company announced in an earnings report that early data showed the shot was 96% effective against Covid in teens ages 12-17. These data were based on those who had received at least one dose of the vaccine.

The company said Tuesday that the shot in the study was 93% effective after one dose. For this it used the definition of Covid-19 from the Centers for Disease Control and Prevention, which only requires one symptom and a positive Covid test.

US regulators are expected to approve Moderna’s application for teenage use. The approval process could take about a month, in time for some summer activities and fall Classes if Moderna submits the data by the beginning of June. Pfizer and BioNTech, for example, filed for expanded use of their shot in teenagers on April 9th ​​and were approved by the FDA on May 10th.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to medical experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity, and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

According to health experts, vaccinating children can also accelerate the return of personal learning and enable after-school activities such as sports, arts, and other personal activities after school.

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Health

Pfizer and Moderna Pictures Are Powerfully Efficient in opposition to Virus, Evaluation Says

Pfizer and Moderna Shots Are Powerfully Effective against Virus, Analysis Says

Pfizer-BioNTech and Moderna Coronavirus vaccines are 94 percent effective at preventing symptomatic Covid-19 disease, according to a new study of 1,800 US healthcare workers.

The research the Centers for Disease Control and Prevention published on Friday provides even more evidence that the vaccines work well outside of controlled clinical trials.

“This report provided the most compelling information yet that Covid-19 vaccines are working as expected in the real world,” said Dr. Rochelle Walensky, CDC director, in a statement Friday.

“This study, which was added to the many previous studies, was instrumental in changing the CDC’s recommendations for those fully vaccinated against Covid-19.”

The results are based on an ongoing study of healthcare workers in 25 states. This interim analysis included data on 1,843 healthcare workers who were routinely tested for coronavirus infection. More than 80 percent of the participants were female.

About 623 workers tested positive between January and mid-March. Those who were fully vaccinated were 94 percent less likely to develop symptomatic coronavirus infections than their unvaccinated counterparts, the researchers found. The numbers are consistent with the effectiveness estimates from the clinical studies.

The scientists also found that a single dose of the two-shot regimen was 82 percent effective in preventing symptomatic infection. This number is higher than reported in other studies and may be due to the relative youth of the study participants, who had an average age of 37 to 38 years. Less than 2 percent were 65 years of age or older.

CDC scientists had previously found that fully vaccinated health, frontline, and essential workers were 90 percent less likely to get coronavirus. These results helped allay fears that vaccinated people might even asymptomatically transmit the virus and spread it to others.

Concern was a major reason for asking vaccinated Americans to continue wearing masks, a recommendation the CDC overturned Thursday.

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Moderna says vaccine generates promising immune response in opposition to variants

Moderna says vaccine generates promising immune response against variants

A doctor draws a syringe of Moderna’s vaccine.

Oliver Berg | Image Alliance | Getty Images

A booster of Moderna’s Covid-19 vaccine triggered a promising immune response against variants B.1.351 and P.1, which were first identified in South Africa and Brazil, respectively, the company announced on Wednesday, citing early data from an ongoing clinical study.

In the study, Moderna is testing a 50 microgram dose of its vaccine in previously vaccinated people. The booster dose was found to increase neutralizing antibody responses against the original virus, as well as against B.1.351 and P.1, two variants that have since spread to other countries, including the United States

The company also said that a booster shot of its other vaccine, which it calls mRNA-1273.351, produced an even better immune response over its current vaccine against the B.1.351 variant from South Africa. The new vaccine is a variant-specific booster shot that targets B.1.351.

The preliminary results, which Moderna says will be published online, have not yet been peer-reviewed.

“As we seek to defeat the ongoing pandemic, we continue to seek to be proactive as the virus evolves,” said Stephane Bancel, CEO of Moderna, in a press release. “We are encouraged by this new data, which increases our confidence that our booster strategy should protect against these newly discovered variants.”

According to Moderna, the side effects were similar to those seen after the second dose of the vaccine in the previously reported studies. Side effects included injection site pain, fatigue and headache, and muscle and joint pain.

The new data comes as drug makers and scientists now say people will likely need a booster shot of Covid-19 vaccines and possibly additional shots each year, just like they did with seasonal flu.

Moderna’s vaccine requires two doses four weeks apart. As with Pfizer and Johnson & Johnson, the shot against Covid is very effective, although company executives and officials now say they expect this strong protection to wear off over time. Pfizer’s vaccine is also a two-dose therapy, while the J&J immunization is just one burst.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, previously said that Americans may need booster vaccinations to better protect themselves from variants.

Earlier Wednesday, US health officials said highly contagious variants are still a “wild card” in their nationwide campaign to vaccinate most American adults by July 4th.

A report by the Centers for Disease Control and Prevention published on Wednesday predicted that Covid-19 cases will increase until May due to the highly contagious variant B.1.1.7 first identified in the UK, before declining sharply by July, because vaccinations reduce infections. Still, variants threaten to reverse the nation’s progress, officials said,

“We are seeing that our current vaccines protect against the pollutants circulating in the country. Put simply, the sooner more people are vaccinated, the sooner we will all get back to normal,” said CDC Director Dr. Rochelle Walensky during a Covid press conference at the White House.

Moderna 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.

Bancel told CNBC last month that the company is hoping to have a booster shot for its two-dose vaccine in the fall.

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The Pfizer and Moderna vaccines are 94 % efficient at stopping hospitalization in older adults, a examine finds.

The Pfizer and Moderna vaccines are 94 percent effective at preventing hospitalization in older adults, a study finds.

Pfizer BioNTech and Moderna coronavirus vaccines prevent 94 percent hospitalization of fully vaccinated adults aged 65 and over, according to a small study published Wednesday by the Centers for Disease Control and Prevention.

The results, which are in line with clinical trial results, are the first real evidence from the US that the vaccines protect against severe Covid-19. Older adults are at the highest risk of being hospitalized and dying from the disease. More than 573,000 people have died from the virus across the country, according to a New York Times database. As of Wednesday, 142.7 million people had received at least one dose of one of three federally approved vaccines, including about 98 million people who were fully vaccinated.

“These results are encouraging and welcome news for two-thirds of people 65 and older who are already fully vaccinated,” said Dr. Rochelle Walensky, CDC director, in a statement. “Covid-19 vaccines are highly effective and these real world results confirm the benefits of clinical trials preventing hospitalizations among the most vulnerable.”

The study is based on data from 417 patients enrolled in 24 hospitals in 14 states between January 1 and March 26. About half were 75 years or older.

Both the Pfizer and Moderna vaccines require two shots three to four weeks apart. Older adults who were partially vaccinated – that is, received a dose of the vaccine more than two weeks earlier – were 64 percent less likely to be hospitalized with the coronavirus than unvaccinated seniors, the researchers reported.

The vaccines did not reduce hospitalization rates in people who received their first dose less than two weeks earlier. It takes time for the body to build an effective immune response, and people are considered fully vaccinated two weeks after the last dose in the series.

“This also underscores the persistent risk of serious illness shortly after vaccination, before a protective immune response has been achieved, and increases the need for vaccinated adults to continue physical distancing and prevention behaviors,” the scientists wrote.

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J&J requested Pfizer, Moderna to assist research blood clots however they declined: WSJ

J&J asked Pfizer, Moderna to help study blood clots but they declined: WSJ

A person walks past a sign that reads “The vaccine is our best shot against COVID-19” on the Upper West Side amid the coronavirus pandemic in New York City on March 30, 2021.

Noam Galai | Getty Images

Johnson & Johnson has privately asked Covid-19 vaccine competitors Pfizer and Moderna to participate in a study examining the potential risk of blood clots. The companies refused, however, the Wall Street Journal reported on Friday, citing people familiar with the matter.

Pfizer and Moderna executives said their vaccines were safe and they didn’t see the need to redouble efforts by regulators and companies already addressing the rare blood clot problem, the journal’s report said.

Only AstraZeneca, whose vaccine raised regulatory concerns about blood clots, agreed to join the effort, the Journal said.

CNBC has asked the four companies to comment.

On Tuesday, the Food and Drug Administration and Centers for Disease Control and Prevention advised states to temporarily suspend use of J & J’s vaccine “out of caution” after six women developed a rare but potentially life-threatening bleeding disorder Dead and one left in critical condition.

The women developed a condition known as cerebral venous sinus thrombosis (CVST) within about two weeks of receiving the shot, US health officials told reporters. CVST is a rare form of stroke that occurs when a blood clot forms in the venous sinuses of the brain. It can eventually leak blood into the brain tissue and cause bleeding.

A CDC panel on Wednesday decided to postpone a decision on J & J’s vaccine use while officials investigate the cases.

Read the full Wall Street Journal report here.