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FDA Claims A Covid-19 Vaccine Needs To Be 50% Effective To Be Distributed 

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This past summer the Food and Drug Administration (FDA) announced that in order for a Covid-19 vaccine to be approved for federal regulation and distribution it would need to be safe and “prevent disease or decrease its severity in at least 50% of people who are vaccinated.” 

No vaccine is 100% effective, however, some do work better than others depending on how high that percentage is. For example, one of the most successful vaccine’s out there is the treatment for measles, which after two doses works to be 97% effective in preventing the disease. Dr. Jeff Kwong is a professor of public health and family medicine and interim director of the Center for Vaccine Preventable Diseases at the University of Toronto, who recently spoke with the media about this percentage.

“I know that 50 percent does sound low but that is still some protection, and some protection is better than no protection.”

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The FDA set this percentage to be relatively low through their emergency use authorizations, which can speed up the process in which a vaccine or drug treatment is distributed to the public if the danger is imminent enough. This means, however, that a vaccine could become available that will only help half of the people receiving it. It could also impact people differently, some might become fully immune from it, and some may just have a reduced case should they be infected. 

A 50% effective Covid-19 vaccine, however, is way better than no vaccine, according to the FDA. Experts used the flu vaccine as an example, claiming that its effectiveness can vary year to year based on how severe the actual flu season is. Within the past decade alone the flu vaccine has fluctuated between 20% and 60% in terms of effectiveness, however, it always reduces the amount of illness, hospitalizations and influenza caused deaths, according to the US Centers for Disease Control and Prevention (CDC).

Dr. Gregory Poland is the director of the Mayo Clinic’s Vaccine Research Group who recently discussed the substantial impact a 50% effective Covid-19 vaccine could actually have on the nation.

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“If you had a 60 or 70 percent effective vaccine and everybody took it, you might actually be reaching toward herd immunity and potentially then dampen down this pandemic.”

Right now, however, researchers still don’t know how effective each experimental vaccine is because the trials are ongoing. Poland explained that most of the clinical trials occurring are focusing on how much the vaccine actually prevents the disease. Once the studies are completed it will be revealed who benefited the most from vaccination. 

Researchers are focusing on different demographics to get a greater understanding over how this virus may impact certain individuals differently. For example, some studies are focusing on how a vaccine may affect a man versus a woman, individuals of different age groups, or individuals with underlying health conditions. 

Once a vaccine is one the market it’s still going to take a while for the pandemic to come to a close, as vaccinating millions of people takes time, so policies such as facial coverings, social distancing and hand washing will continue to exist in our world for quite some time. 

Peanut Allergy

The FDA Has Approved The World’s First Peanut Allergy Medication

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It’s estimated that about 1.6 million children and teens in the United States are allergic to peanuts. It’s one of the most common and severe allergies in our world today, and until this year there seemed to be no feasible way of combating such a huge epidemic that affects so many individuals. However, a major treatment that’s been in the works for quite some time now has finally been approved by the Food and Drug Administration (FDA) to be distributed amongst the general public. 

The treatment is called Palforzia, and was developed by Aimmune Therapeutics, a company whose main goal has always been to find the most effective treatments for all types of allergies. Palforzia works a lot like traditional vaccines against diseases such as the flu; by putting a little bit of the virus itself into the patient’s body. In this case the “virus” that’s being introduced to allergen patients is a specially prepared peanut powder that’s ingested daily. 

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Giving someone with a severe peanut allergy trace amounts of peanut powder may sound like a recipe for disaster, but it is safe. The amount of powder swallowed daily is extremely small, and over the course of a few months, the amount is gradually increased until the child/teens body is better equipped to tolerate peanuts in the case of an accidental bite. It’s important to note that Palforzia is not a cure for peanut allergies, but instead is a treatment for those with an extreme allergy to the nut so that if they do accidentally ingest something with peanuts in it in the real world, it won’t be as much of an urgent situation. Those who take Palforzia must continue to avoid eating peanuts. 

“Peanut allergy carries an overwhelming psycho-social burden that impacts patients and their families daily – peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families’ daily lives. The risk of accidental exposure is real, and we, as a community, have long awaited an option beyond avoiding peanuts alone. We are thrilled with today’s FDA approval of Palforzia as it fills a long-standing need in the treatment of peanut allergy,” said Lisa Gable, Chief Executive Officer, Food Allergy Research and Education.

Palforzia is more than just the world’s first treatment for peanut allergies, it’s actually the first treatment for food allergies in general. However, the scientists behind the vaccine want the public to know that the treatment is not for everyone, as like any other medication, it can have some serious side effects; one of which being an occasional severe allergic reaction. It’s for this reason alone that as the drug begins getting prescribed to individuals, the FDA is requiring all patients to enroll in a special safety program that entails only taking the first dose, and each increased dose, under the supervision of a trained medical expert at a certified health center, according to the press release. 

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Aimmune also mentioned in their official release that they hope to begin handing out prescriptions within the next month. As of right now Palforzia costs $890 per month, but it will vary based on insurance and Aimmune also will be offering a “patient co-pay assistance program.” As a treatment for one of the deadliest allergies in the world, the demand is set to be high, but the effectiveness makes it completely worth it. So how does it work exactly?

“The powder, stored in a capsule, is mixed into any unheated food. Patients take the first dose in a doctor’s office, in case of a bad allergic reaction. Every few weeks, the dose is increased until after about six months, they’re taking the equivalent of about one peanut. In a study of nearly 500 children, two-thirds who received Palforzia could eat the equivalent of two peanuts,” (AP).

When it comes down to if a drug such as Palforzia will be worth it for you or your child, it really is a matter of how severe the allergy is, and what your physician thinks. During the study about 9% of the subjects had severe reactions, hence the need for the initial doses to be done under a doctor’s supervision. Like any new medical treatment, there’s just as many risks as there are benefits. 

The ultimate goal is that Aimmune will be able to use the same science that went into Palforzia for other allergy medications; the company is already in its preliminary testing stages for medications combating dairy or fish allergies. Only time will tell how much more effective these treatments become, but for now, we can celebrate this as one of the greatest medical accomplishments to happen to the allergy community.

Baby Powder

Johnson & Johnson Recalls Baby Powder After Discovering Traces Of Asbestos

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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.

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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. 

Smoking

The FDA Hopes A Picture Really Is Worth 1000 Words In New Proposed Anti-Smoking Effort

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The Food and Drug Administration has proposed for the use of graphic images portraying the negative effects of smoking on cigarette packages. This is part of a greater effort that the FDA has been working on for years involving graphic content to “scare” smokers into quitting. 

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