Johnson & Johnson Claim Booster Shots Will Increase Immune Response 

Johnson & Johnson reported this week that booster doses of its one-shot Covid-19 vaccine generated a big spike in antibodies. Individuals who received a booster shot six to eight months after their initial J&J shots say their antibodies “increase nine-fold higher than 28 days after the first shot,” Johnson & Johnson said.

The data itself comes from two Phase 2 studies conducted in both the United States and Europe. J&J claim that around 2,000 individuals received a booster shot six months after their initial dose. 

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“New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination,” the company said in its statement.

“We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses. With this new data, we also see that a booster dose of the Johnson & Johnson vaccine further increases antibody responses.”

J&J claimed that it’s currently in talks with the US Food and Drug Administration, US Centers For Disease Control and Prevention, European Medicines Agency, World Health Organization, and other health authorities about offering a booster dose of the Janssen vaccine. 

“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” Mammen added.

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According to the CDC around 14 million Americans have received the J&J vaccine. Dr. Dan Barouch is a vaccine researcher at Beth Israel Deaconess Medical Center and Harvard Medical School who has been studying the J&J vaccine.

“The boost at six months is going to look very impressive and substantially greater than what has already been reported in terms of the two month boost, and that is significant because, in my opinion, the boost should not be at two months, but it really should be at six months or later.”

Neither of the studies have looked at real-world efficacy yet, meaning the company hasn’t yet determined if the booster shot will prevent severe disease, but researchers are confident that the antibody levels they’re seeing in their initial research indicated immune protection. 

“I’m quite certain that the FDA, CDC, NIH, White House will use these data to likely justify or recommend a booster for J&J-vaccinated people, probably with a second shot of J&J,” Barouch explained.

German Scientists Claim They Can Improve Covid Vaccines To Further Prevent Blood Clots 

A team of scientists in Germany believe that they have figured out why an increased number of individuals have experienced blood clots after receiving the AstraZeneca and Johnson & Johnson Covid-19 vaccines. 

The scientists also believe that they can tell the manufacturers how to improve the vaccine itself to avoid clots. Rolf Marschalek, a professor at Goethe university in Frankfurt, and colleagues spoke with the media recently about their discovery. 

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“The key is in the adenovirus – the common cold virus that is used to deliver the spike protein of the coronavirus into the body. The mRNA vaccines developed by Pfizer/BioNTech and Moderna do not use this delivery system and there have been no blood clotting cases linked to them.”

The blood clots have been very rare, as with any vaccine, however, many parents are concerned about the younger age groups receiving their vaccines as there’s already less of a chance that they’ll develop severe Covid illness, but an increased risk that they would experience a blood clot. 

Currently the UK is offering vaccines to anyone under the age of 40 wherever vaccines are available. There have been 309 blood clotting cases in the UK out of 33 million people given the AstraZeneca vaccine. The scientists in a preprint analysis claim that they believe the “problem lies in the entry of the adenovirus into the nucleus of the cell rather than just the cellular fluid, where the virus normally makes proteins.” 

“The adenovirus life cycle includes the infection of cells entry of the adenoviral DNA into the nucleus, and subsequently gene transcription by the host transcription machinery. Here lies the problem: the viral piece of DNA is not optimised to be transcribed inside of the nucleus.”

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Inside of the cell’s nucleus, parts of the spike protein splice, or split apart. These sliced pieces can then become mutant protein pieces that free float throughout your body, and lead to an increased risk of blood clots; although it’s extremely rare that that will occur. 

Professor Marschalek claims that Johnson & Johnson are already in discussions with him, as he’s only continued to emphasize that “the vaccines can be redesigned to avoid the problem.” 

“Johnson & Johnson is trying to optimize its vaccine now. With the data we have in our hands we can tell the companies how to mutate these sequences, coding for the spike protein in a way that prevents unintended splice reactions.”

No word on whether or not AstraZeneca has been contacted or not, and the research presented still needs to go through a peer review in order for it to gain more national credibility throughout the United Kingdom.

Johnson & Johnson Vaccine

CDC Expected To Meet About J&J Vaccine Pause

The CDC and FDA are meeting to discuss the six blood clotting cases among people who received the Johnson & Johnson Covid-19 vaccine.

Doctor Holding Coronavirus Vaccine Syringe

Vaccine Providers Pledge 240 Million Covid-19 Vaccine Doses By The End Of March 

Johnson & Johnson has joined Pfizer and Moderna in their commitment to the US to provide a total of 240 million vaccine doses by the end of March. The drug companies told a House subcommittee this week that they expect to deliver this amount of doses after Johnson & Johnson pledged to add 20 million additional doses to Pfizer and Moderna’s 220 million dose pledge should the company receive emergency use authorization from the US Food and Drug Administration this week. 

Dr. Richard Nettles is J&J’s vice president of medical affairs who spoke with the lawmakers regarding the company’s pledge should they receive the EUA as expected. 

“If the emergency use authorization is received as expected this week, we hope to contribute to ending this pandemic as soon as possible.”

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Nettles claims that the company is prepared to ship out 4 million doses immediately upon authorization of the vaccine. Executives from each of the vaccine makers testified before the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations this past Tuesday. 

If AstraZeneca secures an FDA authorization as well it will become the fourth Covid-19 vaccine available in the US. Dr. Ruud Dobber, the executive vice president and president of AstraZeneca’s biopharmaceuticals business unit, said the company “will immediately release 30 million doses upon authorization of the vaccine and up to 50 million doses by the end of April.”

Pfizer initially planned to deliver up to 40 million doses of their vaccine by the end of 2020, however, they just reached that milestone last week. Moderna was close to reaching their goal of 20 million doses by the end of 2020 but fell short by just a week. Executives for the companies claimed that a lack of access to raw materials and manufacturing a product that has never been made before were the main issues in production. John Young, Pfizer’s chief business officer, recently spoke about this issue to the media. 

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“We did initially experience some problems with the initial ramp up of our vaccine. We particularly saw some rate-limiting steps for raw materials.” 

“We ultimately had never–when we were trying to make those estimates — manufactured at this scale, and so we had a lot to learn along the way. As we look back, could we have maybe started earlier in that process and lining up all of the critical raw materials sooner, would we have been able to get there a little bit faster instead of the first week of January, last week of December? It’s possible. Certainly hindsight, and that is 20-20 for us,” said Moderna’s president Dr. Stephen Hoge.

Moderna is currently seeking FDA approval for increasing the number of doses in each Covid-19 vaccine vial from 10 to 15. Hodge claims this would “accelerate delivery substantially and decrease the demand for some critical, high-demand raw materials. Obviously, any gains — for instance, filling more doses in a vial — we will take. We need to get more doses more quickly into peoples’ arms.”

Johnson & Johnson will be finding out if they receive an emergency use authorization this Friday.

Johnson & Johnson Vaccine

Johnson & Johnson Single-Shot Covid-19 Vaccine 85% Effective Against Virus 

Johnson & Johnson announced some promising news this week, claiming that their single-shot Covid-19 vaccine is proving to be 66% effective at preventing symptomatic disease and 85% effective against preventing severe illness. 

Dr. Mathai Mammen is the global head of Janssen Research & Development who spoke with the media about how “elated and joyful” the room was when the team of scientists concluded those percentages. 

“We’re a single shot and now we’ve produced data that says our vaccine is highly effective. 85% against severe Covid and 100% effective against hospitalization or death.”

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Mammen continued to claim that “we’ve had the objective of producing a vaccine for the world, that is easily used, is easily distributed and it works against preventing the form of COVID-19 that people care about, meaning an illness that can make you severely sick at home and lead to hospitalization or death. The vaccine is safe, volunteers experienced mild reactions after the shot, with less than 10% experiencing fever.”

The Food and Drug Administration (FDA) has said that it will consider any vaccine that’s more than 50% effective, and since the Johnson & Johnson vaccine is now surpassing that threshold, the Administration will likely review the data and place an emergency use authorization on it to begin distribution before the end of February. 

The US is currently projected to receive up to 300 million vaccines from both Pfizer and Moderna, which would almost vaccinate the entire population. With the release of another vaccine option, the country will be more than set for achieving herd immunity by the end of the Summer as the Biden Administration is already predicting. 

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“With its single-shot administration and more convenient transportation and storage requirements,  this vaccine really is a workhorse vaccine. We’re delighted to see that this vaccine has good efficacy against mild disease [and] outstanding efficacy against severe disease … [in] all geographic regions studied,” said Dr. Dan Barouch of the Beth Israel Deaconess Medical Center, who collaborated with Johnson & Johnson in the development of the vaccine.

The Johnson & Johnson vaccine trial was composed of more than 44,000 volunteers from a variety of countries, just like the other vaccine trials. This way the company could see if the vaccine impacted certain demographics differently than others, and like Pfizer and Moderna they luckily found that it didn’t, and was equally as effective for everyone. 

“So, this is probably the single most exciting result in our entire clinical study that we have 85% protection against severe COVID, irrespective of where in the world you’re talking about and what kind of variants you’re talking about,” Mammen said.

Johnson & Johnson is currently planning studies in children and pregnant women to really ensure the vaccine is safe for those more vulnerable groups. If the FDA provides emergency use authorization to the company, they claim that they could distribute 100 million doses to the US by June.

Vaccine Development

Johnson & Johnson Pause Covid-19 Vaccine Trial Due To Unexplained Illness Appearing 

Johnson & Johnson have become the latest to put their Covid-19 vaccine trial on pause due to an unexplained illness appearing in one of the participants. AstraZeneca and the University of Oxford also made headlines recently when they had to pause their trial for the same reason. The AstraZeneca trial, however, has resumed in Canada and Europe, just not the US. 

For Johnson & Johnson, however, a document was recently sent out to outside researchers who were running the clinical trial – which involved 60,000 patients – that claimed a “pausing rule” had been met and the trial was to stop immediately until a proper investigation into the sick individual has been performed. 

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The online system that’s been used to enroll patients in the study has been officially closed and all data that’s already been collected from various committees would be collected and analyzed together. Johnson & Johnson recently spoke with the media about putting their trial on pause but provided little information based on the fact that they themselves are still working on the investigation. 

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

Johnson & Johnson did emphasize in their statement that adverse events like this happening during a clinical study for a vaccine made for a virus the world knows so little about, is normal. In fact, the AstraZeneca trial has had to pause a few times now due to unexplained illnesses appearing in certain participants. These issues that cause the trials to come to a halt are typically isolated incidents and have to do with the individuals personal health over anything else. 

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They also emphasized the difference between a “study pause” and a “clinical hold” when it comes to vaccine trials. A clinical hold is a formal regulatory action that can cause a vaccine trial to stop for a long-time. This incident, however, falls more under the study pause category, as the company is projecting to restart the trial this week. 

Late Monday evening the data and safety monitoring board, or DSMB, for the Johnson & Johnson trial met to review the case involving this sick participant. When it comes to these illnesses it’s not always immediately clear what the cause is, but the first thing the first thing the DSMB needs to determine is if the patient received a version of the vaccine, or a placebo. 

The fact that this trial is one of the biggest in the world also means that these pauses are likely to occur more than once. Again, AstraZeneca has had to take multiple pauses and their trial involves about half the participants as Johnson & Johnson. A source recently spoke with the media about how common these pauses are.

“If we do a study of 60,000 people, that is a small village. In a small village there are a lot of medical events that happen.” 

Johnson & Johnson initially began enrolling volunteers for Phase 3 of their clinical trial for a Covid-19 vaccine on September 23rd. Researchers initially planned on enrolling 60,000 participants from all over the world and are planning to still hit that number as well.

Baby Powder

Johnson & Johnson Recalls Baby Powder After Discovering Traces Of Asbestos

Johnson & Johnson have been making headlines for all the wrong reasons lately, and now, the trend continues with the company’s announcement of a voluntary recall of their baby powder, for supposedly containing traces of asbestos. The announcement was in response to the US Food and Drug Administration’s test on a random bottle of baby powder, which was positive for chrysotile asbestos. The recall, so far, is contained to one lot of production for the well-known brand of baby powder, and the FDA and Johnson & Johnson are both encouraging everyone to throw away the product if they own a bottle with a manufacturing label that claims the bottle was produced in lot #22318RB, where over 33,000 bottles were distributed, according to CNN.

The FDA also reported that no bottle contained more than .00002% of the chemical, and they’re performing their standard testing on all Johnson & Johnson production facilities to ensure that this exposure was contained. According to CNN, so far the FDA has confirmed no traces of asbestos have been found in any other shipping and packaging facility, and their rigorous testing process is almost complete. They’re assuming this to be a contained incident, but it’s probably smart to avoid Johnson & Johnson products in general, at least for the time being. 

“FDA will be working with Johnson & Johnson to facilitate further investigation to substantiate that the product is authentic. The FDA is not aware of any records pointing to counterfeit Johnson’s baby powder in the US market. The company has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA’s own testing as recently as last month, found no asbestos. Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos,”  FDA spokeswoman Lyndsay Meyer wrote in an email to CNN on Friday.

According to the FDA’s official statement released on Friday, the administration has been doing nonstop intense testing of cosmetic products for asbestos since 2018, they’ve tested over 50 brands. These meticulous and now routine tests are what let the FDA to the asbestos discovery in the Johnson & Johnson production lot. Asbestos has been a major concern in the cosmetic field for the FDA, especially as of the past few years. Claire’s and Justice just received major backlash after the FDA found asbestos in some of their most popularly sold makeup products for young girls. All products that have been recalled within the past few years contained Talc, the main perpetrator. 

“Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently,” according to the FDA.

This is not Johnson & Johnson’s first time being in the news for controversy over their products. They’ve been accused multiple times in the past of having products with asbestos in them, and not saying anything. Mostly, an investigative report from Reuters went viral last year, for seemingly exposing Johnson & Johnson for knowing about the asbestos contamination in their products for DECADES and simply not doing anything about it. The toxic talcum powder can cause cancer and multiple million dollar lawsuits have been filed, and won, against Johnson & Johnson within the past year. For now, most families across the country are boycotting the brand after all the scandals they’ve been involved with, especially scandals that put peoples lives at risk.