Tag: Moderna

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Covid breakthrough danger could also be a lot decrease with Moderna vaccine than Pfizer

Covid breakthrough risk may be much lower with Moderna vaccine than Pfizer

On this illustration from 19.

Given Ruvic | Reuters

The risk of developing a breakthrough COVID-19 infection with the Delta variant after being fully vaccinated with the Moderna vaccine may be much lower than that, according to a new study from the Mayo Clinic awaiting a full review Risk to those who received the Pfizer vaccine.

The study found that in July in Florida, where COVID cases have hit an all-time high and the Delta variant is widespread, the risk of a breakthrough in Moderna recipients was 60% lower compared to Pfizer recipients.

Similarly, last month in Minnesota, the authors found that the Moderna vaccine (also known as mRNA-1273) was 76% effective in preventing infection, but the Pfizer vaccine (known as BNT162b2) was 42% effective.

“Comparing infection rates between matched individuals fully vaccinated with mRNA-1273 with BNT162b2 at Mayo Clinic Health System sites in several states (Minnesota, Wisconsin, Arizona, Florida, and Iowa) found one with mRNA-1273 Twice the risk reduction compared to a breakthrough infection compared to BNT162b2 “, write the authors in their abstract.

The authors found that both vaccines “strongly protect” against serious illnesses; the difference seems to be more whether people become infected at all. The CDC has said that the risk of infection in the unvaccinated is 8 times higher than that of the vaccinated and the risk of hospitalization or death is 25 times higher.

The so-called pre-print study, which was neither peer-reviewed nor published in a scientific journal, was first published on Sunday but received more attention on Wednesday when Axios reported that the Biden administration was using the data as a “wake-up call.” . “

Pfizer told Axios that it and its partner BioNTech “can develop and produce a bespoke vaccine against this variant in about 100 days of a decision, subject to regulatory approval.”

The company confirmed the effectiveness of its vaccines in a subsequent statement, saying it was also determined to develop boosters.

“Pfizer and BioNTech have put in place a robust refresher research program to ensure that our vaccine continues to offer the highest level of protection possible. Initial data from a third dose of the current vaccine shows that a booster dose at least 6 months after the second dose elicits high neutralization titers against the wild-type, beta and delta variants, “Pfizer said in a statement.

Just last week, Moderna warned that breakthrough infections were on the rise, saying those who received his vaccine would likely need a booster shot before winter. And at the end of last month, Pfizer also said that a booster that is already being tested would be effective against the Delta variant.

Data from New Jersey, where Delta now accounts for 90% of all positive COVID samples tested, underscores the key points: Breakthrough infections still make up a very small percentage of new COVID hospital admissions, but that percentage has been increasing significantly in weeks recently.

Fully vaccinated New Jerseyans accounted for 18.5% of all new COVID cases in the July 20-26, said Governor Phil Murphy. More importantly, these cases accounted for 3% of all new hospital admissions.

Murphy cited the data Monday as evidence that vaccines are working, but the fact that as many as 3% of hospitalized COVID patients have been vaccinated is a concern – and with it the direction in which the breakthrough cases are headed to develop.

The proportion of 3% of vaccinated people who were hospitalized with the virus in the period from July 20 to July 26 has increased significantly compared to the proportion of 0.004% in the period up to July 26.

Pfizer accounts for 30% of the more than 10.6 million vaccine doses given in New Jersey to date, while Moderna accounts for about 21%, state data shows.

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Moderna, Canada agree on constructing manufacturing plant

Moderna, Canada agree on building manufacturing plant

Justin Trudeau, Canada’s Prime Minister, listens during a press conference in Ottawa, Ontario, Canada on Friday June 4, 2021. Trudeau said 65% of eligible Canadians received a first dose of the Covid-19 vaccine.

David Kawai | Bloomberg | Getty Images

Moderna said Tuesday it had reached an agreement with the Canadian government to build a “state-of-the-art” manufacturing facility in Canada to manufacture Covid vaccines and possibly vaccines for other respiratory viruses after the country suffered from supply shortages earlier this year.

The facility is designed to give Canadians access to domestically manufactured mRNA vaccines against respiratory viruses, including Covid, seasonal influenza, respiratory syncytial virus and possibly other vaccines, pending approval, the U.S. drugmaker said.

It is also to be used “urgently” to aid the country with health emergencies with direct access to vaccines, the company said.

Moderna said it was in talks with other governments about similar collaborations.

“We are very excited to expand our presence and continue our long-term relationship with Canada,” said Patricia Gauthier, Moderna’s head of Canadian business, in a statement. “With our industry-leading mRNA technology platform and rapid drug development capabilities, we look forward to being an active participant in Canada’s robust life science ecosystem.”

Canada has suffered repeated delays and supply shortages of Covid vaccines this year as it struggled to get the vaccines from other countries that manufactured them. The problem forced the government to postpone the second vaccinations for up to 16 weeks and advise residents to “mix and match” vaccines.

The Biden government, under pressure from allies worldwide to share vaccines, announced plans in March to ship about 4 million doses of AstraZeneca’s Covid vaccine that it was not using to Mexico and Canada.

Vaccine supplies and the pace of vaccinations have increased since then, Canadian health officials said, and residents have since received their second doses.

Moderna shares fell about 3% on Tuesday just before the announcement. The stock is up more than 360% since the beginning of the year.

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Covid delta will result in improve in breakthrough infections: Moderna

Covid delta will lead to increase in breakthrough infections: Moderna

The highly contagious Delta variant will lead to an increase in breakthrough infections in those who are fully vaccinated as people begin to exercise indoors after the summer, Moderna said Thursday.

While Moderna’s two-dose vaccine remains “stable” six months after the second vaccination, immunity to the coronavirus will continue to decline and ultimately reduce the vaccine’s effectiveness, the company said in the slides accompanying its second quarter earnings report were attached.

The company said its vaccine was 93% effective six months after the second dose. By comparison, Pfizer and BioNTech reported that their vaccine effectiveness decreased to about 84% after six months.

“Given this overlap, we believe a dose 3 refresh will likely be needed before the winter season,” wrote Moderna.

Moderna’s warning comes as the Delta variant becomes more widespread in more than 100 countries, including the United States. Delta, the predominant form of the disease in the United States, is more transmissible than the common cold, 1918 Spanish flu, smallpox, Ebola, MERS, and SARS, according to the Centers for Disease Control and Prevention.

A healthcare worker treats a patient in a negative pressure room in the Covid-19 Intensive Care Unit (ICU) at Freeman Hospital West in Joplin, Missouri, Tuesday, August 3, 2021.

Angus seed dressings | Bloomberg | Getty Images

For some Americans, concerns about the effectiveness of the vaccine have grown with the advent of the variant, which can cause more serious illnesses than the original coronavirus. Some people have even gone so far as to look for an extra dose not yet recommended by the CDC. This week, San Francisco health officials announced that they would allow patients who received the Johnson & Johnson vaccine to have a second vaccination from Pfizer-BioNTech or Moderna.

Drug makers have been saying for months that they expect people to need booster shots and perhaps additional doses annually at some point, just like they did with seasonal flu.

Moderna said Thursday that results from a Phase 2 study showed that a booster dose of its vaccine elicited a “robust” antibody response against three variants, including Delta.

The CDC and World Health Organization say booster doses are not currently required due to a lack of data. In fact, on Wednesday the WHO called on wealthy nations to stop distributing Covid booster vaccinations to give the world a chance to meet the WHO’s goal of vaccinating 10% of each country’s population by October.

“We need an urgent turnaround from moving the majority of vaccines to high-income countries and the majority to low-income countries,” said WHO Director-General Tedros Adhanom Ghebreyesus.

The move comes after Israel announced that the country will be giving booster doses to its elderly population. The Dominican Republic has also given its population booster doses, while neighboring Haiti recently secured its first vaccine doses.

People in the US are also finding ways to get booster vaccinations.

– CNBC’s Rich Mendez contributed to this report.

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

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

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

Amy Osborne | AFP | Getty Images

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

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

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

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

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

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

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

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

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

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

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

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

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Moderna says it plans to develop trial for teenagers 5 to 11

Moderna says it plans to expand trial for kids 5 to 11

With her husband Stephen by her side Erin Shih hugs her children Avery 6, and Aidan, 11, after they got their second Moderna COVID-19 vaccines at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021.

Sarah Reingewirtz | MediaNews Group | Getty Images

Moderna plans to expand the size of its clinical trial testing its Covid-19 vaccine in kids ages 5 to 11, the company confirmed to CNBC on Monday.

The U.S. drugmaker is expanding the trial, which began in late March, to increase the likelihood of detecting potential rare side effects, the company said, declining to say how many children it ultimately hopes to enroll. The Food and Drug Administration last month added a warning label to the Pfizer and Moderna Covid-19 vaccines to list a rare risk of heart inflammation, which was reported in young people, as a potentially rare side effect.

“It is our intent to expand the trial and we are actively discussing a proposal with the FDA,” the company told CNBC in a written statement. “At this point, we expect to have a package that supports authorization in winter 2021/early 2022, should the FDA choose to use the authorization avenue.”

The New York Times reported earlier Monday that the FDA asked both Moderna and Pfizer to include 3,000 children in the 5- to 11-year-old trials, citing unnamed sources. One source described that as double the original number of study participants envisioned, according to the Times.

In a statement to CNBC, Pfizer said it has not provided any updates to the previously stated timelines or details for its trial.

The update comes as parents in the U.S. patiently wait for their children to be eligible to get vaccinated. In May, the FDA permitted the use of the Pfizer-BioNTech Covid vaccine for kids ages 12 to 15. Moderna’s vaccine is expected to be authorized for children as young as 12 any day now.

Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a specific disease — until children can get vaccinated, scientists say.

Federal health officials will need to balance the risk of potentially rare side effects from the shots against the risks of getting Covid.

In June, health officials said there had been more than 1,200 cases of a myocarditis or pericarditis mostly in people age 30 and under who received the shots. Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart.

There have been just 12.6 heart inflammation cases per million doses for both vaccines combined, officials said at the time. They added the benefits still outweighed the risks.

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Pfizer and Moderna Vaccines Prone to Produce Lasting Immunity, Research Finds

Pfizer and Moderna Vaccines Likely to Produce Lasting Immunity, Study Finds

The vaccines from Pfizer-BioNTech and Moderna trigger a sustained immune response in the body that can protect against the coronavirus for years, scientists reported on Monday.

The results add to the growing evidence that most people immunized with the mRNA vaccines may not need a booster dose as long as the virus and its variants do not progress much beyond their current forms – which is not guaranteed. People who have recovered from Covid-19 before they were vaccinated may not need a booster vaccination, even if the virus goes through a significant transformation.

“It’s a good sign of how persistent our immunity to this vaccine is,” said Ali Ellebedy, an immunologist at Washington University in St. Louis who led the study, which was published in the journal Nature.

The study did not take into account the coronavirus vaccine manufactured by Johnson & Johnson, but Dr. Ellebedy said he believed the immune response was less permanent than that of mRNA vaccines.

Dr. Ellebedy and colleagues reported last month that in people who survived Covid-19, immune cells that recognize the virus remain dormant in the bone marrow for at least eight months after infection. A study by another team showed that so-called memory B cells continue to mature and strengthen for at least a year after infection.

Based on these results, the researchers suggested that immunity in people infected with the coronavirus and later vaccinated could last for years, possibly a lifetime. However, it was unclear whether vaccination alone could have a similar long-lasting effect.

Dr. Ellebedy addressed this question by examining the source of memory cells: the lymph nodes, where immune cells train to recognize and fight the virus.

After an infection or vaccination, a specialized structure forms in the lymph nodes, the germinal center. This structure is sort of an elite school for B cells – a boot camp in which they become increasingly sophisticated and learn to recognize a multitude of viral genetic sequences.

The greater the range and the longer these cells have to practice, the more likely they are to thwart any virus variants that may appear.

“Everyone is always focused on developing the virus – this shows that the B cells are doing the same,” said Marion Pepper, an immunologist at the University of Washington in Seattle. “And it will protect against the continued development of the virus, which is really encouraging.”

After an infection with the coronavirus, the germinal center forms in the lungs. But after the vaccination, the cells are formed in the lymph nodes in the armpits that researchers can reach.

Updated

July 2, 2021, 5:06 p.m. ET

Dr. Ellebedy and colleagues recruited 41 people – including eight with a history of infection with the virus – who were immunized with two doses of the Pfizer BioNTech vaccine. The team collected lymph node samples from 14 of these people three, four, five, seven and 15 weeks after the first dose.

This meticulous work makes this a “heroic study,” said Akiko Iwasaki, an immunologist at Yale. “This kind of careful time history analysis in humans is very difficult.”

Dr. Ellebedy found that 15 weeks after the first dose of the vaccine, the germinal center was still highly active in all 14 participants and that the number of memory cells that recognized the coronavirus had not decreased.

“The fact that the reactions lasted almost four months after the vaccination – that’s a very, very good sign,” said Dr. Ellebedy. Sprouting centers typically peak one to two weeks after vaccination and then decrease.

“Usually there isn’t much left after four to six weeks,” said Deepta Bhattacharya, an immunologist at the University of Arizona. But germinal centers that are stimulated by the mRNA vaccines “still go in, months, and most people don’t go back much”.

Dr. Bhattacharya noted that most of what scientists know about the persistence of germinal centers is based on animal studies. The new study shows for the first time what happens to people after vaccination.

The results suggest that the vast majority of those vaccinated will be protected in the long term – at least against the existing coronavirus variants. But older adults, people with weak immune systems, and those taking drugs that suppress immunity may need boosters; People who survived Covid-19 and were later vaccinated may not need it at all.

It is difficult to predict exactly how long protection against mRNA vaccines will last. In the absence of variants that bypass immunity, immunity could theoretically last a lifetime, experts said. But the virus is clearly evolving.

“Anything that would actually require a refresher would be variant-based, not immunity waning,” said Dr. Bhattacharya. “I just don’t see it.”

People who have been infected with the coronavirus and then immunized see a sharp spike in their antibody levels, likely because their memory B cells – which produce antibodies – had many months to develop before vaccination.

The good news: a booster vaccine is likely to have the same effect on people who have been vaccinated as a previous infection, said Dr. Ellebedy. “If you give them another chance to get involved, they’ll have a massive response,” he said, referring to memory B cells.

In terms of boosting the immune system, vaccination is “probably better” than recovering from the actual infection, he said. Other studies have shown that the repertoire of memory B cells produced after vaccination is more diverse than that produced by infection, suggesting that the vaccines protect against variants better than natural immunity alone.

Dr. Ellebedy said the results also suggest that these signs of sustained immune response could be caused by mRNA vaccines alone, as opposed to those made by more traditional means like Johnson & Johnson’s.

But that’s an unfair comparison because the Johnson & Johnson vaccine is given as a single dose, said Dr. Iwasaki: “If the J&J had a booster, they might get the same kind of reaction.”

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Las vacunas de Pfizer y Moderna podrían generar una inmunidad duradera, según científicos

Las vacunas de Pfizer y Moderna podrían generar una inmunidad duradera, según científicos

Las vacunas fabricadas por Pfizer-BioNTech y Moderna generan una reacción inmunitaria persistente en el organismo que puede proteger contra el coronavirus durante años, informó el lunes un grupo de científicos.

Los hallazgos se suman a la creciente evidencia de que la mayoría de las personas inmunizadas con las vacunas de ARNm podrían no necesitar refuerzos, siempre y cuando el virus y sus variantes no evolucionen mucho más allá de sus formas actuales, algo que no está garantizado. Es posible que las personas que se recuperaron de COVID-19 antes de ser vacunadas no necesiten refuerzos incluso si el virus realiza una transformación significativa.

“Es una buena señal de lo durable que es nuestra inmunidad proveniente de esta vacuna”, dijo Ali Ellebedy, inmunólogo de la Universidad de Washington en Saint Louis que dirigió el estudio, publicado en la revista Nature.

El estudio no incluyó a la vacuna fabricada por Johnson & Johnson, sin embargo, el doctor Ellebedy dijo que esperaba que la respuesta inmunitaria sea menos durable que la que producen las vacunas de ARN mensajero.

Ellebedy y sus colegas reportaron el mes pasado que en quienes sobreviven a la COVID-19, las células inmunitarias que reconocen al virus permanecen inactivas (durmientes) en la médula ósea durante al menos ocho meses después de la infección. Un estudio de otro equipo indicó que las llamadas células B de memoria siguen madurando y fortaleciéndose durante al menos un año tras la infección.

Los investigadores, con fundamento en esos hallazgos, sugirieron que la inmunidad podría durar por años y tal vez toda la vida en las personas que contrajeron el coronavirus y luego fueron vacunadas. Pero no quedó muy claro si es posible conseguir un efecto tan duradero solo con la vacunación.

El equipo de Ellebedy buscó resolver esa pregunta al examinar la fuente de las células de memoria: los nódulos linfáticos, donde las células inmunitarias se entrenan para reconocer y combatir el virus.

Después de una infección o la vacunación, se forma una estructura especializada llamada centro germinal en los ganglios linfáticos. Esta estructura es una suerte de escuela de élite para las células B, un campo de entrenamiento donde se vuelven cada vez más sofisticadas y aprenden a reconocer un conjunto diverso de secuencias genéticas virales.

Es más probable que estas células logren frustrar a las variantes del virus que puedan surgir si disponen de más tiempo y rango para practicar.

“Todos se enfocan siempre en la evolución del virus; esto muestra que las células B están haciendo lo mismo”, dijo Marion Pepper, inmunóloga de la Universidad de Washington en Seattle. “Y va a proteger contra la evolución en curso del virus, lo cual es realmente alentador”.

Después de contraer el coronavirus, se forma el centro germinal en los pulmones. Pero después de la vacunación, la educación de las células sucede en los nódulos linfáticos de las axilas, al alcance de los investigadores.

Ellebedy y sus colegas reclutaron a 41 personas, incluidas ocho con antecedentes de infección por el virus, que fueron inmunizadas con dos dosis de la vacuna Pfizer-BioNTech. De 14 de estas personas, el equipo extrajo muestras de los ganglios linfáticos a las tres, cuatro, cinco, siete y 15 semanas después de la primera dosis.

Ese laborioso trabajo es lo que hace que este sea un “estudio heróico”, comentó Akiko Iwasaki, inmunólogo de Yale. “Este tipo de análisis cuidadoso de series de tiempo en humanos es muy difícil de realizar”.

El equipo de Ellebedy encontró que a las 15 semanas de recibir la primera dosis de la vacuna, el centro germinal seguía altamente activo en los 14 participantes y que la cantidad de células de memoria capaces de reconocer al coronavirus no había disminuido.

“Que las reacciones continuaran casi cuatro meses después de la vacunación, es una señal muy muy buena”, comentó Ellebedy. Los centro germinales suelen tener su máxima expresión una o dos semanas después de la inmunización y luego declinan.

“Por lo general no suele quedar mucho después de cuatro a seis semanas”, dijo Deepta Bhattacharya, inmunólogo de la Universidad de Arizona. Pero los centros germinales estimulados por las vacunas de ARNm “siguen activas a los meses y no declinan mucho en la mayoría de las personas”.

Bhattacharya indicó que la mayor parte de lo que los científicos saben sobre la persistencia de los centros germinales proviene de la investigación con animales. El nuevo estudio es el primero en mostrar lo que sucede en las personas después de la vacunación.

Los resultados sugieren que una gran mayoría de las personas vacunadas estarán protegidas a largo plazo, al menos contra las variantes de coronavirus existentes. Pero los adultos mayores, las personas con sistemas inmunitarios débiles y aquellos que toman medicamentos inmunosupresores puede que necesiten refuerzos; Es posible que las personas que sobrevivieron a la COVID-19 y luego fueron inmunizadas nunca los necesiten.

Es difícil predecir con exactitud cuánto durará la protección de las vacunas de ARN mensajero. Si no existieran las variantes que esquivan a la inmunidad, esta podría durar en teoría toda la vida. Pero el virus claramente sigue evolucionando.

“Cualquier necesidad de un refuerzo sería a causa de una variante, no de un declive de la inmunidad”, dijo Bhattacharya. “No veo que eso llegue a suceder”.

Las personas que se infectaron con el coronavirus y luego se inmunizaron experimentan un aumento importante en sus niveles de anticuerpos, muy probablemente porque sus células B de memoria, que producen anticuerpos, tuvieron muchos meses para evolucionar antes de la vacunación.

La buena noticia: la vacuna de refuerzo probablemente tendrá el mismo efecto que una infección previa en personas inmunizadas, dijo Ellebedy. “Si les brindas otra oportunidad de participar, responderán de forma masiva”, dijo, refiriéndose a las células B de memoria.

En lo que respecta a reforzar el sistema inmunológico, la vacunación es “probablemente mejor” que recuperarse de la infección real, dijo. Otros estudios han sugerido que el repertorio de células B de memoria que se producen después de la vacunación es más diverso que el generado por la infección, lo que sugiere que las vacunas protegen mejor contra variantes que la inmunidad natural por sí sola.

Ellebedy dijo que los resultados también sugieren signos de una reacción inmunitaria persistente producidos por las vacunas de ARNm, en lugar de por aquellas más tradicionales, como la de Johnson & Johnson.

Pero esa es una comparación injusta, ya que la vacuna de Johnson & Johnson se administra en una sola dosis, dijo Iwasaki: “Es probable que si la J & J tuviera una segunda dosis, podría inducir el mismo tipo de respuesta”.

Apoorva Mandavilli es reportera del Times y se enfoca en ciencia y salud global. En 2019 ganó el premio Victor Cohn a la Excelencia en Reportaje sobre Ciencias Médicas. @apoorva_nyc

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Moderna says Covid vaccine exhibits promise in a lab setting towards variants, together with delta

Moderna says Covid vaccine shows promise in a lab setting against variants, including delta

A healthcare worker prepares a dose of Moderna Inc.’s Covid-19 vaccine on Tuesday February 9, 2021 at the Pacheco Vaccination Center in Brussels, Belgium.

Geert Vanden Wijngaert | Bloomberg | Getty Images

Moderna said Tuesday that its Covid-19 vaccine showed promise against coronavirus variants, including the highly contagious Delta variant, first identified in India in a laboratory setting.

The two-dose mRNA vaccine produced neutralizing antibodies against Delta as well as Beta and Eta, variants that Moderna said were first found in South Africa and Nigeria, respectively.

The company said the results were based on blood serum from eight participants one week after receiving the second dose of the vaccine. The data has not yet been reviewed by experts. The results, while promising, may not reflect how the vaccines actually perform against the variants in real-world scenarios.

Moderna shares rose more than 4% in intraday trading after the lab results were announced.

“We continue to strive to investigate new variants, generate data and share them as they become available,” said Stephane Bancel, CEO of Moderna, in a press release. “These new data are encouraging and reinforce our belief that the Moderna COVID-19 vaccine should continue to protect against newly discovered variants.”

Moderna’s update comes days after World Health Organization officials urged fully vaccinated people to continue wearing masks, maintain social distance, and practice other pandemic safety measures as the delta spreads rapidly across the world.

Delta, now present in at least 92 countries including the United States, is expected to become the predominant variant of the disease worldwide. In the US, the prevalence of the variant doubles about every two weeks.

WHO officials said Friday that they are urging fully vaccinated people to continue to “play it safe” as much of the world remains unvaccinated and highly contagious variants like Delta spread in many countries and cause outbreaks.

The comments were a departure from the Centers for Disease Control and Prevention, which said fully vaccinated Americans can be maskless in most environments.

“People can’t feel safe just because they got the two doses. They still need to protect themselves,” said Dr. Mariangela Simao, WHO Deputy Director General for Access to Medicines and Health Products, during a press conference.

Approved vaccines from Moderna, Pfizer-BioNTech, and Johnson & Johnson have been shown to be highly effective in preventing Covid, particularly against serious illness and death.

Some variants, including Delta, have shown the vaccines to be slightly less effective, and WHO officials said they fear people vaccinated could become part of the chains of transmission.

The Wall Street Journal reported Friday that about half of the adults infected in a Delta variant outbreak in Israel were fully vaccinated with the Pfizer vaccine, prompting the local government to reintroduce indoor masking and other measures.

In the United States, President Joe Biden warned that unvaccinated people are particularly at risk of contracting Delta.

He said the number of Covid deaths would continue to increase across the country due to the spread of the “dangerous” variant, calling this a “serious concern”.

“More than six hundred thousand Americans have died, and with this variant of the Delta, you know there will be others too. You know it will happen. We need to vaccinate young people,” Biden said Thursday at a community center in Raleigh, NC

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FDA provides warning of uncommon coronary heart irritation to Pfizer, Moderna vaccines

CDC group says there isn't enough data yet to recommend booster shots

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021.

Dado Ruvic | Reuters

The U.S. Food and Drug Administration on Friday added a warning to patient and provider fact sheets for the Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of heart inflammation.

For each vaccine, the fact sheets were revised to include a warning about myocarditis and pericarditis after the second dose and with the onset of symptoms within a few days after receiving the shot.

Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart. Health officials said the benefits of receiving the vaccine still outweigh any risk.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, acting FDA commissioner, said in a statement.

“The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,” she said.

The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday. 

There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received the shots, according to presentation slides from the CDC meeting.

About 300 million shots had been administered as of June 11, according to the CDC. There have been just 12.6 heart inflammation cases per million doses for both vaccines combined.

— CNBC’s Berkeley Lovelace Jr. contributed reporting

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U.S. to Purchase 200 million Extra Moderna Photographs, In Case Boosters Are Wanted

U.S. to Buy 200 million More Moderna Shots, In Case Boosters Are Needed

The Biden government, which is planning the possibility of Americans needing booster shots of the coronavirus vaccine, has agreed to purchase an additional 200 million doses from drug maker Moderna, with the option to include all anti-variant and pediatric doses.

The purchase, which shipments are expected to begin this fall and continue next year, gives the administration the flexibility to use booster shots if necessary and vaccinate children under 12 if the Food and Drug Administration approves vaccination for that age group at two Administrative officials who are not empowered to discuss it publicly.

Experts don’t know yet whether or when booster shots might be required. The emergence of variants in recent months has sped research on boosters, and current vaccines are believed to be effective against several variants, including the alpha variant, which was first identified in the UK and became dominant in the United States.

And this week, US health officials classified the Delta variant, first found in India, as a “worrying variant” and raised the alarm because it is spreading rapidly and can cause more severe illness in unvaccinated people. Concerns about Delta caused England to postpone lifting the pandemic restrictions.

Moderna, a company that had no products on the market until the FDA granted emergency approval for the Covid vaccine last year, uses mRNA platform technology to manufacture its vaccine – a so-called “plug and play” – Method that can be particularly adapted to the reformulation. Last month, the company announced preliminary data from a clinical trial of a booster vaccine matched to the beta variant first identified in South Africa; The study found an increased antibody response to beta and gamma, another worrying variant first identified in Brazil.

Announcing the purchase on Wednesday, Moderna said it is expected to ship 110 million of the new cans in the fourth quarter of this year and 90 million in the first quarter of 2022. The option brings all of Moderna’s US procurement of two-shot vaccine up to 500 million doses.

“We appreciate working with the US government on these extra doses of the Moderna Covid-19 vaccine, which could be used as a primary vaccination, including for children, or possibly as a booster dose if necessary to further defeat the pandemic . ”That said Stéphane Bancel, CEO of Moderna.

“We continue to focus on being proactive in the development of the virus, using the flexibility of our mRNA platform to stay one step ahead of emerging variants,” he said.

Under its existing contract with Moderna, the federal government had until Tuesday to exercise the option to purchase doses for future vaccination needs at the same price it currently pays – about $ 16.50 per dose. Similar discussions are ongoing with Pfizer-BioNTech, which also makes a two-dose mRNA vaccine, but no agreement was reached, one of the officials said.

The state health authorities are also preparing for the need for “re-vaccination,” said Dr. Nirav Shah, president of the Association of State and Territorial Health Officials and Maine’s chief health officer, told reporters on Wednesday.

“It may be a little early to be able to say definitively whether second doses or booster doses will be needed in the fall,” said Dr. Shah. “The better work we’re doing now certainly reduces the likelihood that variants could run free.”

He added, “There is a direct link between what we are doing now and what we may need to do later.”

According to the federal government, about 65 percent of US adults had received at least one injection by Wednesday. However, as vaccination rates slow, the government is still focused on meeting President Biden’s goal of getting at least 70 percent of adults vaccinated by July 4th, and also on addressing the global vaccine shortage.

“As the Delta variant in question grows and millions more Americans need to be vaccinated, we are focused on our urgent and robust response to the pandemic,” White House spokesman Kevin Munoz said in a statement Tuesday.

Last week, at the start of his meeting with the leaders of the Group of 7 Nations, Mr Biden announced that the United States would buy 500 million doses of Pfizer vaccine and donate them to about 100 low and middle income countries for use the next Year, describing it as America’s “humanitarian obligation to save as many lives as possible.”

One of the officials said Wednesday that the government would donate these doses to other countries if the purchase of Moderna left the administration with excess vaccine.