Pharmaceutical Technology Editors

Moderna announced on March 16, 2022 that it has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 booster vaccine or an updated booster vaccine candidate for anticipated delivery in the second half of 2022.

Currently there are 93 million doses of Moderna’s COVID-19 vaccine contracted for supply to Japan. The agreement brings the potential total to 163 million doses, contingent to the Ministry securing a budget for the additional supply.

The MHLW has granted authorization for special approval to Moderna’s COVID-19 vaccine for people aged 18 years and older. The vaccine is delivered in two doses 28 days apart, with a booster dose available to be administered after at least six months of the second dose.

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Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine. 

Moderna and the Japanese Government Reach an Agreement to Supply Japan with Additional 70 Million Doses of Moderna’s COVID-19 Booster Vaccine

On March 10, 2022, FDA announced that specific lots of seven of Olympia Pharmacy’s compounded injectable products were found to be out-of-specification. Olympia Pharmacy is voluntarily recalling 11 specific lots of the seven compounded injectables, including Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD.

There have not been any reports, concerns or adverse effects from patients relating to the safety of the recalled compounded products. The products being recalled are typically prescribed for age management, erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder.

The FDA Risk Statement reads as follows: “Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.”

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products 

The makers behind two of the largest COVID-19 vaccines, Pfizer, BioNTech, and Moderna, are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines. Pfizer and BioNTech submitted an appeal to amend their Emergency Use Authorization (EUA) on March 15, 2022, while Moderna submitted one on March 17.

Pfizer and BioNTech’s application is for a booster dose for adults 65 and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. According to a company press release, an analysis of Israeli Ministry of Health records found that confirmed infections were two times lower and rate of severe illness were four times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine administered at least four months after an initial booster dose relative to those who received only one booster dose.

Additionally, Pfizer cited results from an ongoing-open-label, non-randomized clinical trial in healthcare workers 18 and older who had been vaccinated with three doses of the Pfizer-BioNTech vaccine in their submission. Among the 154 (out of 700) participants who received a fourth dose, neutralizing antibody titers increased approximately 7-fold to 8-fold at two and three weeks after the additional booster (fourth) dose compared to five months after the initial booster (third) dose. Additionally, an eight-fold and ten-fold increase in neutralizing antibody titers against the Omicron variant (at one and two weeks after the additional booster dose respectively) were seen compared to five months after the initial booster.

Moderna applied for an amendment to their EUA that would allow for a fourth dose of its COVID-19 vaccine in adults 18 and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. Moderna’s submission is based in part on recently published data from the United States and Israel.

Separately, FDA announced that it would hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., April 6, to discuss considerations for future COVID-19 vaccine booster doses. However, VRBPAC will not be voting or discussing any product-specific applications at this meeting. The committee will also discuss the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose

Digital medicine company physIQ and precision medicine service company CellCarta announced on March 17, 2022 a collaboration on a study to potentially revolutionize vaccine development through a more precise, personalized approach.

The study, called the VIII (Vaccine-Induced Inflammation Investigation) Study, will focus on early, individualized human responses to vaccines as pharma companies release vaccines at a faster pace. Physiology and immune system activation will be monitored remotely at all times using medical-grade biosensors. An artificial intelligence (AI)-based digital platform and immunologic biomarkers allow for individualized baselines to be established by detecting subtle changes within hours after vaccination. These changes have the potential to be linked to long-lasting immune responses to vaccinations.

This precise approach will be able to identify how an individual’s own immune system responds to a vaccine, which offers a new way to measure vaccine efficacy and safety. The VIII study will also potentially be able to evaluate the capacity of a vaccine to product common, expected adverse reactions, as well as the ability of cells/tissues to provoke an immune response.

“Our goal is to provide tools that help accelerate the therapeutic development of personalized vaccine regimens by looking at the full immune response. This is important because we know there are unique differences in how people react to all vaccines,” said Steven Steinhubl, MD, physIQ chief medical officer and principal investigator for the study, in a press release. “By using highly reliable, 510(k)-cleared wearable biosensors instead of consumer devices, we’re able to continuously track multiple medical-grade physiological and behavioral metrics collected during activities of daily living. This near real-time capture of patient data potentially allows us to rapidly correlate physiological changes to immune responses and minimize possible adverse reactions early.”

physIQ and CellCarta are conducting a study to evaluate individual patient response to vaccination using wearable biosensors.

physIQ and CellCarta Collaborate on Personalized Approach to Vaccine Development

US Pharmacopeia (USP), an independent scientific organization, announced on March 16, 2022 that its USP Medicine Supply Vulnerability Insights Series reveals vulnerabilities in global API supply.

The first conclusion released from the Series discusses the significance of large Indian facilities in the manufacturing of API. There are currently 114 facilities in India with more than 30 active US-approved API products, which is significantly higher than any other region of the world.

The 40 external datasets and 250 million data points provided by the Medicine Supply Map show a comprehensive view of the upstream pharmaceutical supply chain. This information can aid in directing regulatory actions to protect against over-concentrated sources of API and build supply resilience.

“USP’s Medicine Supply Map is an innovative early warning system to help identify ingredient and finished product at risk of shortage so providers, manufacturers and governments can take actions to help prevent the shortage from occurring,” commented Ronald T. Piervincenzi, USP CEO. “Without visibility into the medicine supply chain, preparing for the next crisis is not possible.”

“The USP Medicine Supply Map is helping us identify upstream vulnerabilities in the supply chain for various essential medicines and determine those where Phlow’s capabilities in advanced manufacturing can have the biggest impact,” added Dave Levin, MD, chief medical and information officer of Phlow Corp., a US-based pharmaceutical company.

New report released by USP offers a look into API supply-chain vulnerabilities.

USP Medicine Supply Map Reviews Global API Manufacturing 

Sanofi and Blackstone Life Sciences announced on March 15, 2022 a €300 million (USD 331 million) collaboration focused on accelerating the development for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa (isatuximab), a treatment for patients with multiple myeloma.

Funds will be managed by Blackstone Life Sciences, and Sanofi will continue to manage the clinical program and retain full rights and control of Sarclisa. The study for the subcutaneous formulation is expected to begin in late 2022. If the studies and clinical development program are successful, Blackstone will be eligible to receive royalties on future sales.

Sanofi will partner with drug delivery company Enable Injections to advance the development of a subcutaneous delivery for Sarclisa. Sarclisa has already received regulatory approval for intravenous administration to treat patients with relapsed multiple myeloma. The treatment is under investigation for the possibility to treat other hematologic malignancies and solid tumors.

“The collaboration with Blackstone will accelerate our ability to offer patients a subcutaneous anti-CD38 antibody therapy that we believe will be innovative and more convenient,” commented John Reed, MD, PhD, Global Head of Research and Development for Sanofi, in the press release. “We are committed to building an industry-leading, sustainable pipeline with a steady stream of new therapies that have the potential to transform the practice of medicine.”

Sanofi is collaborating with Blackstone Life Sciences to accelerate the development of a treatment for multiple myeloma.