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FDA panel endorses Johnson & Johnson’s COVID-19 vaccine

A U.S. Food and Drug Administration advisory panel on Friday voted to endorse Johnson & Johnson’s coronavirus vaccine, clearing the way for FDA leaders to grant emergency use authorization amid the ongoing fight against COVID-19.

The vote was 22-0, with all committee members voting in favor of endorsing the jab for emergency use approval. 

The committee was charged with voting on the following question: “Based on the totality of scientific evidence available, do the benefits of the Janssen COVID-19 Vaccine outweigh its risk for use in individuals 18 years of age and older?”

Although significant, the committee’s vote in favor of emergency use authorization (EUA) is not final. The vote will now go before FDA officials who will decide whether to grant EUA based on the committee’s findings. Such approval would come after the regulatory agency granted EUA to both the Pfizer-BioNTech and Moderna jabs late last year. 

JOHNSON & JOHNSON SAYS IT CAN PRODUCE 20M DOSES OF COVID-19 VACCINE BY LATE MARCH

The FDA panel’s vote to approve the company’s EUA was expected, as the vaccine was found to have a “favorable safety profile with no specific concerns identified that would preclude issuance of an EUA,” the FDA said in documents posted ahead of Friday’s meeting of the panel of independent experts.

The vaccine candidate — derived from an adenovirus vector formula, unlike the vaccines created by Moderna and Pfizer-BioNTech which were created using mRNA technology — showed to be 66.9% effective against moderate-to-severe disease in a global trial two weeks post-vaccination, per the documents. 

HOW DO WE KNOW COVID-19 VACCINES ARE SAFE?

The committee noted no COVID-19-related deaths in vaccinated individuals as of Feb. 5, though seven COVID-19-related deaths occurred in the placebo group. All seven deaths involved individuals at study sites in South Africa with at least one underlying health condition.

“These results suggest that the vaccine is efficacious against mortality associated with COVID-19,” the documents read.

WHAT’S THE DIFFERENCE BETWEEN MRNA VACCINES AND CONVENTIONAL ONES?

However, the committee noted that vaccine efficacy results had “limited interpretability” for those aged over 75 and “certain racial groups.” There was not enough data to assess vaccine efficacy in those previously infected.

The most common reactions associated with the vaccine included pain at the injection site, headache, fatigue and myalgia, which were mostly “mild and moderate,” resolving within two days post-vaccination. Participants ages 18-59 experienced reactions occurring soon after vaccination more often than those aged over 60, per the documents. 

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It’s worth noting that if the FDA clears the J&J shot for U.S. use, it will not boost vaccine supplies significantly right away. Only a few million doses are expected to be ready for shipping in the first week. But J&J told Congress this week that it expects to provide 20 million doses by the end of March and 100 million by summer.

Still, “once approved for emergency use, the J&J vaccine will become the third sharp arrow in our quiver to defeat this awful virus. More production means more people will be vaccinated sooner – to mitigate transmission, quell the pandemic, and reduce future deaths,” Dr. Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and former Centers for Disease Control and Prevention (CDC) chief medical officer, recently told Fox News.

Fox News’ Kayla Rivas and the Associated Press contributed to this report. 

Johnson & Johnson COVID-19 vaccine headed for FDA committee vote: What the experts say

A U.S. Food and Drug Administration advisory committee on Friday is slated to vote on Johnson & Johnson’s one-dose COVID-19 jab, with the panel expected to recommend that the FDA formally grant the shot emergency use approval in a race to vaccinate as many Americans as possible in the continued fight against the novel coronavirus.

The jab —  derived from an adenovirus vector formula, unlike the vaccines created by Moderna and Pfizer-BioNTech which were created using mRNA technology and have already seen emergency use approval — was found to have a “favorable safety profile with no specific concerns identified that would preclude issuance of an EUA,” the FDA said in documents posted ahead of Friday’s meeting. 

The vaccine candidate proved to be 66.9% effective against moderate-to-severe disease in a global trial two weeks post-vaccination, with the company seeking authorization for use in individuals ages 18 and older.

If the committee endorses the vaccine, and the FDA clears the J&J shot for U.S. use, it will not boost vaccine supplies significantly right away. Only a few million doses are expected to be ready for shipping in the first week. But J&J told Congress this week that it expects to provide 20 million doses by the end of March and 100 million by summer.

FDA EASES PFIZER COVID-19 VACCINE SHIPPING, STORAGE TEMPERATURES

Still, “once approved for emergency use, the J&J vaccine will become the third sharp arrow in our quiver to defeat this awful virus. More production means more people will be vaccinated sooner – to mitigate transmission, quell the pandemic, and reduce future deaths,” Dr. Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and former Centers for Disease Control and Prevention (CDC) chief medical officer, recently told Fox News in an interview. 

“The availability of additional vaccines should help address the gap between the number of people who qualify for and want vaccination and vaccine availability. This is great news,” added Dr. Alan Kadish, physician and president of the Touro College & University System, to Fox News.

Studies have shown that the Pfizer and Moderna vaccines are 95% effective at protecting against symptomatic COVID-19, a greater efficacy when compared to the J&J jab at 66.9%. Should Americans be worried about which vaccine they get, especially if the J&J one has reduced effectiveness?

Not really, said Amler. 

HOW DO WE KNOW COVID-19 VACCINES ARE SAFE?

“Let’s look at practical efficacy, rather than efficacy reported from studies of closely monitored populations” he suggested. “Practical efficacy is affected by many additional real-world factors not found in studies.” 

For instance, said Amler, J&J’s single-dose gives it an advantage over its two-dose counterparts simply because it’s a one-dose jab. 

“Think of all the 2nd-dose appointments avoided, that people won’t forget or miss. Think of the much easier refrigeration requirement versus extreme low-temperature freezing when shipping and storing vaccine. With these practical factors, we can consider the vaccines are practically equivalent,” he continued. 

It’s worth noting, however, that the FDA said Thursday it is allowing more flexible shipping and storage temperatures for the Pfizer-BioNTech coronavirus vaccine. The change permits transportation and two-week storage at -25 degrees Celsius to -15 degrees Celsius, which is often found in pharmaceutical freezers and refrigerators.

When it comes to choosing a vaccine, if the country ever reaches a point where that is an option, the two experts had mixed responses, with Amler noting that “there is no need to choose,” as the “FDA and CDC have indicated no preference between the two vaccines currently approved for emergency use.”

WHAT’S THE DIFFERENCE BETWEEN MRNA VACCINES AND CONVENTIONAL ONES?

“I think that for the next several months, people should get whatever vaccine is available to them because they are all substantially effective. It could be that by late summer or fall, individuals will have a choice and at that point, we will have additional data to determine if one vaccine is better than the other,” added Kadish. 

Finally, is there anyone who should avoid the J&J jab, considering it is an experimental viral vector vaccine that uses a weakened live pathogen — adenovirus in this case? 

While Amler advised waiting for official recommendations following official emergency use authorization, Kadish noted that some groups may need to avoid the J&J vaccine due to the way it was created. 

“Patients who are immune-suppressed or perhaps those who are pregnant should not get the live-action [vaccine],” said Kadish. He noted, however, that the allergic reactions seen with the Moderna and Pfizer jabs “seem less common with the J&J vaccine.”

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Both experts, however, encouraged those eligible to get vaccinated as soon as possible. 

“Everyone should get vaccinated as soon as vaccine is available and they are eligible. If young people who are eligible due to underlying conditions feel awkward lining up with seniors, they should look past their embarrassment and get the protection,” Amler advised. 

Fox News’ Kayla Rivas and the Associated Press contributed to this report. 

When will the Johnson & Johnson COVID-19 vaccine be available?

While a single-shot coronavirus vaccine developed by Johnson & Johnson is pending U.S. regulatory approval, a decision is expected in the coming days. An endorsement from an independent group of experts and an emergency use authorization from the Food and Drug Administration would spark a rollout of up to 4 million jabs across the U.S. early next week.

In a briefing held Wednesday, Jeff Zients, White House COVID-19 coordinator, said that the U.S. is “ready to roll out this vaccine without delay.”

“While we await the FDA’s decision we want the American people to know that we are doing the work so that if the EUA is granted, we will waste no time getting this lifesaving vaccine into [the] arms of Americans,” he said.

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“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, previously said. 

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The company previously pledged 20 million doses delivered by the end of March, pending regulatory approval. Projected deliveries from Pfizer, Moderna and Johnson & Johnson combine for 240 million doses slated for late March, and 700 million jabs by mid-year, the latter of which is more than enough to vaccinate the U.S. population.

Zients said the U.S. is averaging 1.4 million doses of vaccine administered per day, down from last week’s average of 1.7 million. Data compiled by the Centers for Disease Control and Prevention (CDC) says over 22.6 million Americans have received two doses, meaning 6.8% of the country’s population is fully vaccinated.

Fox News’ Alexandria Hein contributed to this report.

Is the Johnson & Johnson COVID-19 vaccine safe?

A third COVID-19 vaccine could enter the fight against the novel virus in the coming days. But what does its safety profile look like?

While a panel of independent experts are deliberating endorsement for the vaccine Friday, staff at the Food and Drug Administration released documents earlier this week, finding the jab had a “favorable safety profile with no specific concerns identified that would preclude issuance of an EUA.”

The briefing documents noted no COVID-19-related deaths in the vaccinated trial group as of Feb. 5, suggesting the vaccine reduces COVID-19-related mortality. There were seven coronavirus-related deaths in the placebo group.

HOW DO WE KNOW COVID-19 VACCINES ARE SAFE?

The most common reactions associated with the vaccine included pain at the injection site, headache, fatigue and myalgia, which were mostly “mild and moderate,” resolving within two days post-vaccination. Participants ages 18-59 experienced reactions occurring soon after vaccination more often than those aged over 60.

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE

“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” per the documents. The committee noted five cases of urticaria, or red swelling, among vaccinated participants, compared to one in the placebo group. The committee said this non-serious event was “possibly related to the vaccine.” Further, insufficient data behind blood clots and tinnitus couldn’t pin a “causal relationship between these events and the vaccine.”

How does Johnson & Johnson’s COVID-19 vaccine compare to Pfizer, Moderna?

A coronavirus vaccine developed by Johnson & Johnson could potentially clear U.S. regulatory hurdles over the next day, and authorization would mark the third jab in the country’s arsenal against the novel virus.

But how do the shots compare?

While previously authorized vaccines developed by Moderna and Pfizer-BioNTech operate on a newer platform with mRNA, or messenger RNA, technology, Johnson & Johnson’s candidate involves a more traditional modified adenovirus vector vaccine with a durable protein exterior encasing the DNA, lending itself to a longer shelf-life.

WHAT’S THE DIFFERENCE BETWEEN MRNA VACCINES AND CONVENTIONAL ONES?

While Pfizer and Moderna’s vaccines each require a two-dose regimen, Johnson & Johnson’s candidate needs just a single dose, which helps to ease logistics.

Late-stage clinical trials showed Pfizer’s vaccine was 95% protective against severe COVID-19 disease, while Moderna had 94.1% efficacy and Johnson & Johnson’s candidate had a 66.9% efficacy. However “efficacy” under controlled conditions in clinical trials is not the same as “effectiveness” in imperfect real-world conditions. Results this week showed Pfizer’s vaccine was 94% effective in a study conducted in Israel involving some 1.2 million people, consistent with the high efficacy reported during clinical trials.

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Further, Johnson & Johnson’s vaccine candidate is stable for up to two years at -20 degrees Celsius and at least three months at 2 to 8 degrees Celsius. Moderna’s vaccine can last at -20 degrees Celsius for six months and 2 to 8 degrees Celsius for 30 days. Meanwhile, the FDA just eased permitted shipping and two-week storage temperatures for the Pfizer vaccine to -25 degrees Celsius to -15 degrees Celsius in a significant shift from an ultra-cold temperature requirement of -80 degrees Celsius and -60 degrees Celsius for up to 6 months. 

Pfizer’s vaccine was authorized for use in people 16 years and older, while Moderna’s was approved for those 18 and up, like Johnson & Johnson’s candidate if the FDA finds it safe and effective. Companies are now assessing the vaccines in younger age groups.

UK coronavirus variant now accounts for 10% of US cases, CDC director says

The coronavirus variant first detected in the U.K. late last year now accounts for up to 10% of COVID-19 cases in the U.S., officials said Friday. The 10% marks an uptick in prevalence, Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC) said. Just a few weeks ago, the variant accounted for about 1-4% of illnesses, she added. 

Officials had previously predicted the B.1.1.7 variant, estimated to be about 50% more transmissible than the wild strain first detected in the U.S., would become the dominant strain in the country by mid-March. Walensky said that the U.S. “may now be seeing the beginning effects” of the variants in the most recent data, which reflected an uptick in several seven-day averages.

The recent trend of declining rates of hospitalization admissions, new cases and deaths has started to level off, she said, signaling a “concerning shift in trajectory.” Walensky added that the declines had followed the highest peak the country had seen during the pandemic.

FDA EASES PFIZER COVID-19 VACCINE SHIPPING, STORAGE TEMPERATURE REQUIREMENTS

The CDC is also monitoring the discovery of two new variants, one in New York and the other in California, which “also appear to spread more easily and were contributing to a large fraction of infection in those areas,” Walensky said.

“We may be done with the virus, but clearly the virus is not done with us,” she said.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, added that vaccine developers are taking several approaches to combat the worrisome variants. One approach, he said, is to create new boosters specifically targeting the variant, such as the one Moderna developed against the South Africa variant. Another option, he said, is simply adding a boost to the existing vaccine to higher the titer of antibody against the wild type of virus. 

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While at least one booster is nearing trial, Fauci called on Americans to get vaccinated as soon as possible to lower the rates of virus in the community.

“Viruses will not mutate if you don’t give them the opportunity to spread and replicate,” he added, echoing Walensky’s call to double down on public health measures.

Andy Slavitt, the White House senior advisor for COVID-19 response, also urged against relaxing restrictions and mitigation measures despite the recent increase in vaccination efforts.

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“The progress we have made [is] better than where we were weeks ago but it is nowhere near the baseline we need to achieve as a country,” Slavitt said.  

Annie’s removing a chemical in mac and cheese linked to fertility issues

Annie’s Homegrown, largely known for its “organic” macaroni and cheese line, is taking steps to remove a potentially harmful class of chemicals, called ortho-phthalates, from its products and packaging materials. 

These chemicals make plastic flexible, and phthalates have already been banned in many kids’ toys over health concerns. Some scientists say the chemicals harm fertility, health of babies, disrupt hormones key for development and damage genetic material in sperm. One 2016 study in particular tied exposure to the chemicals to “diminished sperm count and deteriorated sperm quality, which may lead to infertility.”

“We are troubled by the recent report of phthalates found in dairy ingredients of macaroni and cheese and take this issue seriously,” reads a recent update to Annie’s website. The company noted that these chemicals can be found in manufacturing equipment and has a firm foothold in supply chains beyond just the food industry. The Centers for Disease Control and Prevention (CDC) says phthalates can be found in personal hygiene products, makeup, plastic packaging and more.

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The FDA hasn’t established a level for the amount of phthalates permitted in foods, though Annie’s notes “any trace of phthalates [in mac and cheese products] are below the EFSA [European Food Safety Authority] standard.”

Fox News has request comment from the FDA.

The update on Annie’s website also reads, “We continue to work with our trusted suppliers to eliminate ortho-phthalates that may be present in the packaging materials and food processing equipment that produces the cheese and cheese powder in our macaroni and cheese.”

General Mills, which bought Annie’s in 2014, shared a statement with Fox News on Friday, writing in part, “We are committed to learning more to better understand this emerging issue and determine how Annie’s can be a part of the solution.”

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The update follows a 2017 study by advocacy groups posted ahead of peer-review and funded by the Environmental Health Strategy Center, finding pthalates in almost a dozen macaroni and cheese products, though the brand names weren’t disclosed, the New York Times reported.

Meanwhile, the CDC says “human health effects from exposure to low levels of phthalates are unknown,” adding that more research is needed.

Moderna COVID-19 vaccine trial in kids ages 12 to 17 hits full enrollment

Moderna has completed enrollment for a Phase 2/3 study of its COVID-19 vaccine in adolescents ages 12 to 17. In an update posted Thursday, the company said it had completed enrollment “of 3,000 participants.”

The company has previously predicted that it will have results ahead of the upcoming school year.

The two-dose jab received emergency use authorization in December for individuals ages 18 and older. The Pfizer-BioNTech vaccine, also a two-dose jab, was approved weeks earlier for use in individuals 16 and older. Johnson & Johnson submitted an EUA request for use of its one-shot vaccine in individuals 18 years and older, with the decision pending.

FDA EASES PFIZER COVID-19 VACCINE SHIPPING, STORAGE REQUIREMENT

Since the initial approvals, both Moderna and Pfizer have announced plans to study the vaccine in pediatric patients. Pfizer has since completed enrollment for its trial involving children ages 12 to 15 years old.

Moderna’s CEO Stephane Bancel has said that he believes data on children younger than 11 will not be available until 2022. The company must first see the data from the trials involving 12 to 17 year olds before it can adjust for the younger populations.

Combatting vaccine hesitancy among adults in the U.S. has been a pivotal point of the nation’s rollout, with many questioning the timeline of development versus the typical years-long process. Top officials, like Dr. Anthony Fauci, the nation’s leading infectious disease expert, has repeatedly said that technological advancements and federal funding made it possible.

HOW WOULD COVID-19 VACCINE MAKERS ADAPT TO VARIANTS?

“Vaccines are key, safe mechanisms that protect individuals and populations against infectious diseases,” the American Academy of Pediatrics said, in it’s interim guidance for COVID-19 vaccination in children and adolescents. “Building on existing science, numerous vaccines directed against SARS-CoV-2, the virus that casues COVID-19, have proceeded through development and are now in clinical trials.”

The group lauded the FDA and Centers for Disease Control and Prevention (CDC) process for approval and vaccination recommendations before stating:

“The AAP recommends that anyone 16 years of age and older who meets criteria in phased implementation groups, as recommended by the ACIP, receive the COVID-19 vaccine.”

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It later added that it is “critical that pediatric patients of all ages be included in trials as quickly as possible.”

FDA eases Pfizer COVID-19 vaccine shipping, storage temperatures

The Food and Drug Administration (FDA) said Thursday it is allowing more flexible shipping and storage temperatures for the Pfizer-BioNTech coronavirus vaccine. The change permits transportation and two-week storage at -25 degrees Celsius to -15 degrees Celsius, which is often found in pharmaceutical freezers and refrigerators. 

Pfizer previously said the vaccine has demonstrated stability when stored at these temperatures and the approval would allow greater flexibility for shipping, distribution and pharmacies’ and vaccination centers’ management of the shot.

The vaccine was first authorized to be stored in an ultra-cold freezer at temperatures between -80 degrees Celsius and -60 degrees Celsius, and can remain stored at these temperatures for up to 6 months. They are shipped in specially-designed thermal containers that can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days. 

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The ultra cold chain requirement for Pfizer’s vaccine has been a significant logistical snag in the country’s vaccination campaign. Thawed vials cannot be refrozen, and reports have documented wasted vials as they spoiled, amid a backdrop of limited supply issues nationwide. In some cases, providers scrambled to administer doses before the jabs spoiled, also true for Moderna, sometimes resulting in vaccinations among lower-priority individuals.

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a release posted Thursday. “This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”

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The change does not apply to thawed vials, which can last in the refrigerator for five days before dilution, and six hours after dilution.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in a previous news release. “We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their supply.” 

Fox News’ Alexandria Hein contributed to this report.

How would COVID-19 vaccine makers adapt to variants?

How would COVID-19 vaccine makers adapt to variants?

By tweaking their vaccines, a process that should be easier than coming up with the original shots.

Viruses constantly mutate as they spread, and most changes aren’t significant. First-generation COVID-19 vaccines appear to be working against today’s variants, but makers already are taking steps to update their recipes if health authorities decide that’s needed.

COVID-19 vaccines by Pfizer and Moderna are made with new technology that’s easy to update. The so-called mRNA vaccines use a piece of genetic code for the spike protein that coats the coronavirus, so your immune system can learn to recognize and fight the real thing.

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If a variant with a mutated spike protein crops up that the original vaccine can’t recognize, companies would swap out that piece of genetic code for a better match — if and when regulators decide that’s necessary.

Updating other COVID-19 vaccines could be more complex. The AstraZeneca vaccine, for example, uses a harmless version of a cold virus to carry that spike protein gene into the body. An update would require growing cold viruses with the updated spike gene.

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The Food and Drug Administration said studies of updated COVID-19 vaccines won’t have to be as large or long as for the first generation of shots. Instead, a few hundred volunteers could receive experimental doses of a revamped vaccine and have their blood checked for signs it revved up the immune system as well as the original vaccines.

More difficult is deciding if the virus has morphed enough to modify shots.

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Globally, health authorities will monitor coronavirus mutations to spot vaccine-resistant mutations. They’d also have to decide whether any revamped vaccine should protect against more than one variant.

Overall the process would be similar to what already happens with flu vaccine. Influenza viruses mutate much faster than coronaviruses, so flu shots are adjusted every year and must protect against multiple strains.