Pfizer Initiates Phase 2/3 Clinical Trial of COVID-19 Treatment

March 16, 2022 - Pfizer recently initiated a Phase 2/3 clinical trial to evaluate the safety, pharmacokinetics, and efficacy of its COVID-19 treatment, Paxlovid, in non-hospitalized, symptomatic pediatric patients. 

The open-label, multi-center EPIC-PEDS trial enrolled nearly 140 pediatric patients under 18 years of age. The first Cohort of patients included patients aged 6–17 weighing over 88 pounds, and Cohort 2 included patients 6–16 weighing over 44 pounds.  

Participants enrolled in Cohort 1 will receive Paxlovid (nirmatrelvir/ritonavir 300 milligrams/ 100 milligrams) orally twice daily for 5 days, while patients enrolled in Cohort 2 will receive the drug (nirmatrelvir/ritonavir 150 milligrams/100 milligrams) orally twice daily for the same time.  

Additionally, Pfizer is developing an age-appropriate formulation for three additional planned cohorts of children younger than 6 years old. The company will include these younger age groups as data from Cohorts 1 and 2 and the new formulation are available. 

“Paxlovid is already authorized or approved in many countries around the world, with more than 1.5 million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease,” Mikael Dolsten, chief scientific officer and president of global research and development at Pfizer, said in the announcement.  

READ MORE: Pfizer COVID-19 Vaccine Can be Used in Adolescents, FDA Says

“We are proud to expand studies of our novel COVID-19 treatment to include pediatric participants to further evaluate the safety and efficacy of this treatment in this important population,” Dolsten continued.  

In December 2021, FDA authorized Paxlovid to treat mild-to-moderate COVID-19 in adults and pediatric patients after the tablets reduced the risk of hospitalization or death by 89% within 3 days of symptom onset and 88% from any cause compared to placebo within 5 days of symptom onset.  

Notably, there were no deaths observed in the treatment group.  

African Company to Manufacture J&J’s COVID-19 Vaccine  

Janssen Pharmaceuticals recently partnered with South African-based Aspen SA Operations to enable the first COVID-19 vaccine manufacturing by an African company for individuals living in Africa. 

Currently, just 12% of people in Africa are fully vaccinated, falling well below the World Health Organization’s target of 70% population coverage for all countries.  

READ MORE: SAGE, WHO Support Johnson & Johnson COVID-19 Vaccine Booster

Under the terms of the agreement, Aspen can produce an Aspen-branded finished vaccine and make doses available to the public sector in Africa, including 25 member states of the African Union and key multilateral entities supporting the country’s COVID-19 vaccination drive.  

“We initiated clinical trials in all regions of the world to generate evidence across multiple geographies and diverse, at-risk populations and forged a strategic partnership with Aspen in Africa and others to manufacture our vaccine globally,” Martin Fitchet, MD, head of global public health at Johnson & Johnson, Cilag GmbH International, said in the announcement.  

“We’re proud to take our long-standing collaboration with Aspen to the next level, to continue to address the COVID-19 threat and lay the groundwork for a healthier, more secure future for people in Africa,” Fitchet continued.  

To date, Johnson & Johnson shipped over 200 million vaccine doses to Africa through a combination of advanced purchase agreements with the African Vaccine Acquisition Trust, Gavi, the Vaccine Alliance, and other government donations. 

Thermo Fisher Develops Viral Inactivation to Safely Transport COVID-19 Samples 

Thermo Fisher Scientific’s InhibiSURE Viral Inactivation Medium formula to reduce the risk of exposure during COVID-19 sample transport and process is now available in Europe.  

READ MORE: FDA Authorizes Thermo Fisher’s COVID-19 New Test Collection Method

The rapid transport medium uses a non-hazardous formulation and leakproof format during the collection and inactivation of patient COVID-19 samples. The medium also stabilizes viral RNA at ambient temperatures for transport and in vitro diagnostic testing procedures.   

This single-use device can sample patients suspected of being infected with SARS-CoV-2 or sample individuals for population screening for SARS-CoV-2. Notably, the device is strictly for professional use only.  

“InhibiSURE Viral Inactivation Medium enables us to support a safe and efficient sample collection and transport process by rapidly inactivating the SARS-CoV-2 virus using a non-hazardous formulation,” Duncan Porter, general manager, sample collection and transport for Thermo Fisher’s microbiology business, said in the announcement. 

“To broaden the scope of those capabilities, we’ve prioritized the expansion of the range of viruses, as well as the ability to do at-home collection as future developments,” Porter continued.  

InhibiSURE Viral Inactivation Medium helps keep staff safe with a non-hazardous formula, provides a convenient format that can be used with unprocessed nasal swabs, boosts simplicity by removing the need for de-activation steps, and is suitable to use with bead and column-based PCR systems. 

Thermo Fisher Scientific highlighted its plans of launching the device in other regions, pending relevant regulatory approvals.