. Prior to joining MJH Life Sciences in 2020, he has covered a variety of fields and markets including diabetes, oncology, ophthalmology, IT, travel, and local news. You can email him at 

John Parkinson

Welcome to our series, 1 Big Question, which asks 1 question to the medical community and we get their feedback on an important infectious disease topic.

In this episode, our 1 Big Question is: Looking at C diff as a whole, would you say the medical community is doing a better job overall of treatment and what challenges remain?

We interviewed Sahil Khanna, MBBS, MS, who is professor of Medicine in the Division of Gastroenterology and Hepatology at Mayo Clinic; Glenn Tillotson, PhD, FIDSA, FCCP, GST Micro LLC; Payal K. Patel, MD, MPH, Division of Infectious Diseases assistant professor, University of Michigan Health System and medical director of Antimicrobial Stewardship, VA Ann Arbor; and Anurag Malani, MD, infectious diseases specialist, St. Joseph Hospital, and a fellow of Infectious Diseases Society of America (IDSA).

Check out our video to hear their insights.

Videos

What are the efforts being made with antibiotic stewardship and treatments, and what areas in clinical care do medical professionals want to see improvements.  

Where Are We With Clostridioides Difficile?

Earlier this week, the US Centers for Disease Control and Prevention (CDC) provided new recommendations for people to begin wearing masks again—depending on where people lived—and even in those fully vaccinated.

 specifically asked vaccinated people to wear masks again when indoors in public settings in parts of the US with “substantial” to “high” transmission. The CDC has created a 

 on its site to help the public determine the level of transmission in the county they live in.

The CDC also reversed its recommendations on mask wearing in schools, stating that all teachers, administrators, staff, students, and visitors should wear a mask indoors regardless of vaccination status.

"In recent days I have seen new scientific data from recent outbreak investigations showing that that Delta variant behaves uniquely differently from past strains of the virus that cause Covid-19," CDC Director, Rochelle Walensky, MD, said. "This new science is worrisome and unfortunately warrants an update to our recommendations."

This recommendation has led to confusion and possibly a bit of a shrug from the public especially in people who are vaccinated, not understanding what the “new science” was.

The belief had been that people who are vaccinated are protected and not in danger to themselves or others, and at least initially when the CDC mask guidance was lifted back in May, collectively we thought we had turned a corner for the better. 

 this week, Walensky said new research showed that vaccinated people infected with the Delta variant carry tremendous amounts of the virus in the nose and throat.

This is a departure from the previous variants where it was believed that vaccinated people would not transmit the virus. Suddenly, this has become something everyone, not just the unvaccinated, are having to confront.

The CDC is expected to release the data today about the new variant, and outbreaks among the vaccinated. However, as this information has not been published, it has led to not fully understanding why the sudden change on masks again.

If communication is key to helping the public and the medical community understanding where the new guidance comes from, then a transparent accounting with the data being shared to decipher why the new recommendations.

Articles

With new mask guidance comes questions and confusion, especially with the new strain of COVID-19 and those who have been vaccinated.  

Even for Fully Vaccinated, Masks are Back and Delta Variant Appears the Culprit 

BioNTech announced this week it is launching its Malaria Project with its centerpiece being the development of a vaccine to prevent malaria. The company is planning on developing multiple vaccine candidates featuring known Malaria targets such as the circumsporozoite protein (CSP), as well as new antigens discovered in the pre-clinical research phase. The company is looking to start its first clinical trial with its vaccine candidate by the end of next year.

“The response to the pandemic has shown that science and innovation can transform people's lives when all key stakeholders work together towards a common goal. We are committed to bringing our innovations to those who need them most,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said. “We are more than grateful to be part of the joint efforts of the Eradicate Malaria project. Together with our partners, we will do whatever it takes to develop a safe and effective mRNA-based Malaria vaccine that will prevent the disease, reduce mortality and ensure a sustainable solution for the African continent and other regions affected by this disease.”

The secondary goal for BioNTech is the development of sustainable vaccine production and supply solutions on the African continent. BioNTech is exploring possibilities to set up state-of-the-art mRNA manufacturing facilities, either with partners or on its own. The facilities are expected to manufacture various mRNA-based vaccines upon approval to ensure sustainable supply operations.

“Our efforts will include cutting-edge research and innovation, significant investments in vaccine development, the establishment of manufacturing facilities, and the transfer of manufacturing expertise to production sites on the African continent and wherever else it is needed” Sahin said.

This project is in coordination with the ‘eradicateMalaria’ initiative, led by the kENUP Foundation, to accelerate the eradication of Malaria.

In 2019, according to the World Health Organization (WHO), there were an estimated 229 million cases of malaria worldwide. The estimated number of malaria deaths stood at 409,000 in 2019.

Children aged under 5 years are the most vulnerable group affected by malaria. In 2019, they accounted for 67% (274,000) of all malaria deaths worldwide. The WHO African Region carries a disproportionately high share of the global malaria burden. In 2019, 94% of malaria cases and deaths worldwide were reported on the African continent.

The company is planning to use its mRNA platform to develop the vaccine for malaria, which is the same successful technology it harnessed for its COVID-19 vaccine.

BioNTech to Develop a Malaria Vaccine

The confluence of three factors—Pfizer’s earnings, a new dominant variant, and a decreasing immunity against COVID-19—are all coming together to incentivize the pharmaceutical company to make the case for a booster shot.

Their vaccine, BNT162b2, developed with pharmaceutical company, BioNTech, has provided a great financial windfall for Pfizer. The company reported its 2nd quarter earnings on Wednesday, and said it had $7.8 billion in sales from the vaccine in the quarter. In addition, the company also has enormous expectations for earnings around their COVID-19 vaccine for the rest of this year. “...anticipates 2021 Revenues of Approximately $33.5 Billion for BNT162b2, Reflecting 2.1 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-July 2021,” the earnings report stated.

The Delta variant was recently reported to be 83% of cases in the US, and has spread quickly over just a couple of months. As 

 Editor-in-Chief Jason Gallagher, PharmD, pointed out in a recent tweet, “Ending 5/22 Alpha 69.1%, Delta 3.1% Ending 7/17 Alpha 8.3%, Delta 83.2% That's <2 mos. The fitness of Delta is incredible.”

And, it is unmistakable the impact the COVID-19 vaccines have made, even with the Delta variant. To get a glimpse of the impact of the vaccines and how they have made a tremendous difference, you have to look no further than the US.

In Orange County, Florida alone—home to Disney World and Orlando— they have reported as many as 1000 COVID-19 cases a day recently. And that is just in one county. That is more than the whole state of New Jersey, which reported 600 cases daily. The vaccination rate in Orange County, Florida is 52.64% with a population of 1,324,194 people, and the vaccination rate in NJ is 65.24% with a population of 8,882,190 people.

And if you consider India’s struggles with the Delta variant this past spring, and not having the benefit of vaccination it overwhelmed their hospitals and medical infrastructure, and it caused a high mortality rate.

In the background and likely to play a bigger role is what the data is reporting. There has been a mixture of news on that front with waning immunity and that the Delta variant is having a slight effect on the vaccine’s efficaciousness. 

In a study coming from England, and published in the 

, they reported on the differences in efficaciousness in the Delta and Alpha variants using the Pfizer-BioNTech vaccine. “With the BNT162b2 vaccine, the effectiveness of two doses was 93.7% (95% CI, 91.6 to 95.3) among persons with the Alpha variant and 88.0% (95% CI, 85.3 to 90.1) among those with the Delta variant.”

“Only modest differences in vaccine effectiveness were noted with the Delta variant as compared with the Alpha variant after the receipt of two vaccine doses,” the investigators concluded in their study.

Israel has reported a waning immunity in their data. In a report in the 

, the findings showed reduced efficacy in the Pfizer vaccine.

“The findings, which are preliminary and based on a small sample, suggest that after two shots the vaccine was 39% effective at reducing the risk of infection and 40% effective at reducing the risk of symptomatic disease during a period when the Delta variant dominated cases in Israel, according to the country’s Health Ministry,” the 

reported. “The vaccine was 91% effective at preventing severe illness in the same period between June 20 and July 17, the ministry said.”

Another concern is the concept of breakthrough infections. For those who are fully vaccinated, not much is known in terms of how many people are suffering these infections and if the Delta variant is causing more of them compared to previous dominant variants.

While discussions of an additional booster dose has been ongoing for many months and the healthcare community has said this might be a necessity, the debate still remains unresolved.

Earlier this month, Pfizer-BioNTech announced they

 for an emergency-authorized third dose and was going to submit real-world data.

In response, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) spoke with Pfizer about the data but the federal officials said the need for an additional shot remained inconclusive.

Pfizer has maintained it has said all along there might be a need for a booster shot and that the emergence of the Delta variant has moved up the timeline. "I remember saying we believed, based on the data, we will need a booster eight to 12 months from second dose," Pfizer CEO Albert Bourla, stated on a 

. "We have seen with Delta we might need it a little earlier."

With its latest earnings report showing the financial impact of the vaccine, the Delta variant becoming the dominant strain in the US, and concerns of waning immunity, the company believes there is evidence for an additional booster shot. 