Killian Meara

Applying germicidal ultraviolet-C (UVC) light to common disinfectants could make them safer to use and could also help them to better fight 

, according to investigators with the University of Waterloo in Ontario, Canada.

Results from their study were published in the journal 

“With concerns about the spread of COVID-19, people are utilizing products with BAK as an active ingredient more than ever,” said Manlong Xu, the study’s lead author. “For many industries, there is the demand to improve the efficacy of standard disinfection procedures, while also keeping in mind any potential negative impact on the environment.”

Benzalkonium chloride (BAK), one of the most common active ingredients in many disinfectants that are used in households, food processing plants and hospitals, cannot be used in high concentrations due to its toxicity.

However, in order to protect against harmful viruses and bacteria, high concentrations of BAK are needed, and the residue can harm the environment and people.

For the study, investigators exposed a BAK solution to UVC lamps and then applied the solution to cultured human corneal cells. After 5 minutes, they analyzed the cells for metabolic activity, as well as viability, and found that the BAK solution was neutralized by the UVC and did not harm the cells.

“Our results show that a disinfecting procedure using BAK followed by UVC radiation can minimize the harmful effect of BAK residues on humans and the environment,” David McCanna of Waterloo's Department of Optometry & Vision Science said. “Such a procedure also has a great potential to maximize the disinfection efficacy by utilizing two different antimicrobial mechanisms. As the pandemic continues, our findings are especially important as it provides another method to make our hospitals, food, homes, and the environment safer.”

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Ultraviolet-C light makes benzalkonium chloride, which is found in many disinfectants, safer to use.

Another Possible Disinfecting Use for UV Light Found

The Centers for Disease Control and Prevention (CDC) advised Tuesday that individuals who are fully vaccinated against COVID-19 do not need to wear a mask in many outdoor settings, and even unvaccinated people can skip the face coverings when walking, jogging, or biking outdoors with members of their households.

The announcement coincided with guidance from federal health officials and marked a major step in the easing of pandemic-related restrictions that have been in place for more than a year.

However, the CDC did not go as far to say that fully vaccinated people can altogether drop their marks when they are outdoors, citing the unknown risk of transmitting the disease and unknown vaccination levels of others.

Although this is a promising measure, the CDC still reasserted that individuals should continue wearing face coverings indoors, and that social distancing should still take place no matter the setting.

Officials stated that they hope the easing of these measures for those who are fully vaccinated will help to persuade others who have not been inoculated to receive their shot.

The US has seen a concerning decline in vaccination rates, with average daily administrations dropping below 60,000. Americans are also skipping their second doses at an alarming rate, with 8% of those who received their first shot not showing up to their second one.

The updated guidelines comes after the CDC previously said that fully vaccinated people could gather indoors in small groups without any masks or social distancing, as well as being able to travel without quarantining, as they won’t pose a serious risk to others.

“Today is another day we can take a step back to the normalcy of before,” Rochelle Walensky, the director of the CDC, said. “If you are fully vaccinated, things are much safer for you than those who are not fully vaccinated.”

Individuals vaccinated against COVID-19 do not need to wear a mask outdoors when in small groups, when dining outside, or when biking or running, the CDC announced. However, face-covering precautions should still be taken in some settings. 

CDC Eases Mask Guidance for Vaccinated Individuals in Outdoor Settings

Johnson & Johnson can’t catch a break these days when it comes to breaking into the COVID-19 vaccine market in the United States. On Wednesday, federal regulators ordered the Baltimore plant, operated by Emergent BioSolutions, where nearly 15 millions doses of the Johnson & Johnson vaccine were ruined to temporarily stop all of its production.

 last week by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention to pause administering the vaccine at federal cites because of 6 US cases of rare blood clot disorders that it may have caused.

Regarding the Baltimore site, the FDA issued some highly critical findings and cited a series of shortcomings at the plant in their decision. The inspection was initiated after reports had come to the surface that workers at the plant had accidently contaminated J&J doses with the virus from the AstraZeneca vaccine, which is also manufactured at there.

The FDA included 9 violations in their 12 page report, including a failure to properly disinfect the factory and its equipment, a failure to follow proper procedures which are designed to prevent contamination of doses and having improperly trained employees.

For example, the investigators had discovered that employees would often move back and forth between working with the J&J vaccine and the AstraZeneca doses, without documenting that they had taken the necessary precautions to ensure integrity and cleanliness.

The FDA finished their inspection of the pant on Tuesday.

Noted in the report is that the FDA has not authorized the plant to distribute any does of the vaccines, and that none from the pant have thus far been released for use in the country.

“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” Janet Woodcock, the FDA’s acting commissioner said.

Changes have already begun at the plant, including that they will no longer be manufacturing the AstraZeneca vaccines, as was insisted on by federal officials to limit the potential for cross-contamination.

The inspection was initiated after reports had come to the surface that workers at the plant had accidently contaminated J&J doses with the virus from the AstraZeneca vaccine, which is also manufactured there.

J&J Told to Stop Production of COVID-19 Vaccine at Baltimore Plant

prevention of coronavirus 2019 (COVID-19)

 in the United States began rolling out to distribution sites around the country over the weekend thanks to the granting of an emergency use authorization (EUA) for Moderna’s mRNA-1273 vaccine. The US Food and Drug Administration granted the EUA last Friday night. It follows close on the heels of the FDA’s 

 of the BNT162b2 vaccine by Pfizer/BioNTech for persons aged 16 years and older last week.

The FDA granted the authorization to Moderna, a biotechnology company based in Massachusetts that specializes in messenger RNA (mRNA) therapeutics and vaccines, based on 

 prior to the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting last Thursday.

Accompanying the Pfizer product, the novel vaccine is of the first of its kind to gain license for use in the US, making this a groundbreaking achievement in the field of vaccination research and implementation.

The mRNA-1273 is encoded for a prefusion stabilized form of the SARS-CoV-2 Spike S protein, a protein complex that is critical for membrane fusion and host cell infection. The vaccine was created in collaboration between Moderna and investigators from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID).

Moderna’s mRNA-1273 is a new approach to vaccines to protect against infectious diseases. Although the technology of nucleoside-modified messenger RNA platform-hosted vaccines have been studied for decades, none have ever been employed for use in the US prior to COVID-19. The interest in this type of vaccine grew at the very beginning of the pandemic, due to the fact they can be created using readily-available materials and can be easily standardized and scaled, allowing for a faster development process.

Unlike traditional forms, mRNA vaccines do not put weakened or inactivated germs inside the body. Rather, they teach cells to make proteins that will trigger an immune response by injecting ribonucleic acid into cells which gives them instructions. The cells then display the protein on their surface, activating the creation of antibodies as in a natural infection. This in turn stimulates a more potent response by the immune system.

“Think of mRNA as a messenger, it transfers genetic instructions [and] it gets information from DNA,” said William Schaffner, MD, Professor of Preventive Medicine at the Vanderbilt University Medical Center. “[Then] it goes into the cell and goes to the factory that’s in the cells that makes protein. This messenger carries the message for the cells to manufacture a specific protein, which we call the spike protein. That’s the part of the virus which is very important against which the vaccine is working. You can’t get COVID from the vaccine and after it gets that instruction into the cell, it disappears.”

The ongoing randomized, stratified, observer-blind, placebo-controlled study assessing the vaccine has included 30,351 participants who were randomized 1:1 to receive intramuscular injections of either 100 μg mRNA-1273 or placebo. The vaccine was administered in 2 doses given 28 days apart in adults who were 18 years of age or older.

Included in the study were 24,907 (82.1%) participants who were considered to be at occupational risk for acquiring the SARS-CoV-2 infection, of whom 7,613 (25.1%) were healthcare workers.

At the interim analysis provided to FDA in the EUA application, mRNA-1273 was found to have an efficacy of 94.5% (95% CI, 86.5%-97.8%) against confirmed COVID-19 14 days after the second dose in participants without evidence of a prior SARS-CoV-2 infection. In total, 11 cases of severe COVID-19 were observed, but all of them occurred in the placebo group.

Data was submitted as an amendment after the initial EUA request from a final efficacy analysis. However, the FDA has not yet independently verified the data from this dataset. The final scheduled efficacy analysis on the primary endpoint, demonstrated an efficacy of 94.1% (95% CI, 89.3%, 96.8%). A lower efficacy was observed in participants ≥65 years of age compared to that in younger adults 18 to <65 years of age.

Moderna has announced that its short-term goal is to produce approximately 500 million doses of mRNA-1273 per year, with the hopes of scaling up global manufacturing to produce a potential 1 billion doses of the vaccine per year in the future.

The company has reached an agreement with the United States government to continue using its U.S.-based manufacturing infrastructure to supply 200 million doses. The US also retains the option to purchase a further 300 million doses as part of the agreement under Operation Warp Speed.

Although the mRNA vaccines pose some meaningful challenges as it pertains to distribution, unlike Pfizer’sBNT162b2, which needs to be kept at a temperature of -70°C, Moderna has recently announced that mRNA1273 can remain stable at temperatures ranging from 2° to 8°C for up to 30 days. This will allow for easier transportation and a wider availability of storage options, permitting the vaccine to be held in places that would not be able to properly preserve Pfizer’s.

Though the authorization, as was granted to Pfizer, allows for the emergency-based and ongoing review-dependent distribution of the vaccine, Moderna would still seek Biologic License Application (BLA) approval for mRNA-1273, making it a marketed vaccine for preventing COVID-19. Additional manufacturing, efficacy, and safety data that provides a greater assurance of the product would warrant a BLA application.

There are still vital questions that need to be answered when it comes to vaccines for COVID-19, such as their safety when given to a larger number of people and the potential for waning immunity over time. How the vaccines influence viral loads and community transmission risks still need to be investigated, however this can only occur when the therapy has been introduced to more people.

The coming weeks and months may bring more potential vaccines forward, most notably AstraZeneca, who has been on the heels of Pfizer and Moderna but ran into issues with their data 

For now, the rollout of Pfizer’s and Moderna’s vaccines show great hope that in the not-too-far future, society can resume some sense of normalcy.

“We appreciate the confidence that the US government continues to have in mRNA-1273, our COVID-19 vaccine candidate,” Stéphane Bancel, Chief Executive Officer of Moderna said. “We continue to scale up our manufacturing capability in the U.S. and outside of the U.S…we will continue to work with regulatory agencies around the globe to continue the rolling review process. We remain committed to helping address this global pandemic with our vaccine.”

Unlike traditional forms, Moderna’s mRNA-1273 vaccine does not put weakened or inactivated germs inside the body. Rather, it teaches cells to make proteins that will trigger an immune response by injecting ribonucleic acid into cells which gives them instructions.

Killian Meara

Articles

Another Possible Disinfecting Use for UV Light Found

CDC Eases Mask Guidance for Vaccinated Individuals in Outdoor Settings

J&J Told to Stop Production of COVID-19 Vaccine at Baltimore Plant

Moderna’s COVID-19 Vaccine Approved by FDA