CHICAGO – Global cases are approaching 60 million with over 1.3 million dead worldwide. The United States continues to be the worldwide leader in infections, with over 12.1 million Sunday including 256,163 deaths to date.
With a record-setting 198,000+ cases reported Friday in the US, people worldwide continue to look ahead at the road-map to a vaccine. With two Phase 3 vaccines now seeking approval by the FDA, let’s take a look at what we know now, and what we hope to see shortly on the development of a COVID-19 solution.
Vitamin D (Preventative Action)
Vitamin D has been determined through studies to be one of few preventative treatments that could affect the overall severity found in COVID-19 patients. Recently a study published in Nature, results found 96.82% of patients administered to the ICU were found to be vitamin D deficient.
Of 90 patients measured in a recent group study, 61 required critical care while 29 were found to be asymptomatic. Only two patients in the group were found to have normal levels of Vitamin D in their system.
Remdesivir (COVID-19 Therapeutic)
A study by the New England Journal of Medicine published early this month found patients in a Remdesivir group had a shorter time to recovery than patients in the placebo group. Early on, the U.S. bought the entire world stock of Remdesivir, a drug marked as a COVID-19 therapeutic.
Recently the World Health Organization (WHO) stated there is no evidence it works.
Regeneron Cocktail (COVID-19 Therapeutic)
The Regeneron Cocktail treatment, which was administered to President Trump in early October after contracting the virus, consists of two antibodies administered through an IV. The combination of the antibodies works to target the spike protein of SARS-CoV-2.
“It is reasonable to believe that casirivimab and imdevimab, administered together, may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients,” said RADM Denise M. Hinton Chief Scientist Food and Drug Administration in an authorization letter Saturday.
The cocktail solution will allow healthcare providers to administer to patients showing mild to moderate symptoms, and at risk for hospitalization. The cocktail is not allowed to be administered to those already hospitalized for the virus or requiring oxygen therapy.
So far, a clinical trial showed significant viral levels were reduced within days of treatment. The Regenreon cocktail was given emergency authorization on Saturday. The distribution will be controlled entirely by the U.S. Government.
Pfizer BioNTech COVID-19 Vaccine (Pending FDA Authorization)
The pharmaceutical manufacturer announced Wednesday a vaccine that’s proven to be 95% effective against COVID beginning 28 days after the first dose. Over 43,000 participants enrolled in the trials that first began in late July demonstrated a consistent efficiency among ages, genders, and ethnicities. Some side effects observed in adults included fatigue (3.8%) and headache (2%). The drug manufacturer also reported among adults age 65 and over, efficiency was 94%.
No case study size was given by Pfizer for older adults participating in the study.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Dr. Albert Bourla, Pfizer Chairman and CEO said in a release. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”
Due to the cold-chain needed to distribute the vaccine, a slow rollout is expected. Pfizer’s drug will need storage at minus 94 degrees and will degrade after five days at normal refrigeration temperatures. The company says it’s confident in the existing cold-chain infrastructure to distribute the vaccine around the world, though the pharmaceutical company provided no timeframe.
Pfizer will devote all four of its facilities to manufacturing and producing over 50 million doses in 2020 with 1.3 billion expected by the end of 2021. Sites overseas will also be utilized to aid in the global supply of the drug.
Moderna’s COVID-19 Vaccine (Pending FDA Authorization)
Moderna’s edge lies in its distribution model. The company claims the vaccine developed can be stored in normal home or medical freezer temperatures for up to six months.
Much like the Pfizer vaccine, Moderna’s solution cracked the 90% mark.
The company claims its vaccine has a 94.5% efficacy. Moderna enrolled over 30,000 participates in the U.S. to aid in trials.
Side effects associated with the Moderna vaccine exceeded those of Pfizer’s solution, with the most common being fatigue. Nearly 10% of participates reported fatigue (9.7%) with the Moderna vaccine. Other side effects following both doses included injection site pain, myalgia, arthralgia, headache, pain, and eyrthema/redness at the site of injection.
Side effects reported by Moderna exceed Pfizer’s findings. Those enrolled found mild or moderate severity, including injection site pain, fatigue, myalgia, arthralgia, headache, pain, and eyrthema/redness at the site of injection.
Both the Pfizer and Mondera COVID vaccines are gene-based drugs requiring twin doses and part of the U.S. Government’s “Operation Warp Speed” program.