J&J indicated it will soon release Phase III data and could file for Emergency Use Authorization with the U.S. Food and Drug Administration by the end of the month.
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Johnson & Johnson is inching closer to seeking authorization of its COVID-19 vaccine. The life sciences giant indicated it will soon release Phase III data and could file for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) by the end of the month.
If authorized, J&J said it will be on track to deliver up to 100 million doses of the vaccine to the United States by the end of June, The Hill reported. If the Phase III data expected to be released next week leads to authorization in the U.S., that will speed up vaccination efforts across the country. Unlike the two authorized mRNA vaccines, J&J’s vaccine is a single-dose regimen. Between the already authorized vaccines in the U.S. and J&J’s, if data is positive, the U.S. would be on track to vaccinate more than 250 million people by the end of the summer.
Earlier this month, J&J released interim data that showed its vaccine was safe and effective. As BioSpace previously reported, after a single vaccination, neutralizing antibodies against COVID-19 were observed in more than 90% of volunteers at Day 29 and 100% of the volunteers between the ages of 18 and 55 at Day 57. To measure the level of efficacy from the vaccine, total data from the Phase III study will be needed. Those results are dependent upon a percentage of people in the trial actually being diagnosed with COVID-19 following vaccination.
Elsewhere:
Mother’s Milk – The University of Texas Medical Branch received a three-year, $300,000 grant to determine whether breast milk has an innate ability to stop the spread of COVID-19. The study will determine if an infected mother who has recovered from the virus can pass antibodies to her child through her milk. The research team will examine the breast milk of women who have recovered from COVID-19. Their milk will be tested for antibodies. Also, the researchers will look for viral particulates in the milk as well, The Houston Chronicle reported.
Metformin Recall – Nostrum Laboratories has recalled its diabetes medicine for the second time due to concerns over an ingredient used in the manufacturing being linked to a carcinogen. ArkLatex reported Nostrum has voluntarily recalled one lot of the Metformin HCl extended-release tablets, USP 750 mg, the generic equivalent to Glucophage Tablets. The recall is due to the presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the regulatory agency. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. In large amounts, NDMA can cause health severe problems.
Last year, the FDA announced that high levels of NDMA had been discovered in some of the ER metformin medications it had tested. High levels of NDMA have previously led to the recall of some hypertension and heartburn medications.
Big IPO – Foresite Development II, a blank-check company formed by Foresite Capital, is aiming for a $100 million initial public offering. The company will offer 10 million shares at $10 per share. FS Development II was founded in 2020 and plans to list on the Nasdaq under the symbol FSII, according to a report on Nasdaq.com. Additionally, Foresite Development II plans to raise another $25 million in a concurrent private placement.
Foresite Development II will be Foresite Capital’s second SPAC company. Its previous SPAC, FS Development, went public in August 2020. It has a pending merger agreement with Gemini Therapeutics.
Edible Antibodies -- Seattle-based Lumen Bioscience snagged $14.5 million from CARB-X to fund the development of an oral monoclonal antibody cocktail to prevent serious diarrheal diseases. The CARB-X project will develop an antibiotic-alternative that targets two key pathogens behind the diarrheal diseases that are prevalent in the developing world. The intended product is a low-cost, edible antibody cocktail that can be easily shipped, stored, and used worldwide, including in regions like Africa and parts of Southeast Asia that lack refrigerated distribution.
Fast Track – MeiraGTx secured Fast Track designation for its AAV-CNGA3 gene therapy product candidate for the treatment of achromatopsia (ACHM) caused by mutations in the CNGA3 gene. ACHM is an inherited retinal disease that severely limits a person’s sight by preventing cone photoreceptors in the eye from functioning. Individuals with ACHM are often legally blind from birth and have extremely debilitating sensitivity to light. AAV-CNGA3 is an investigational gene therapy treatment designed to restore cone function, delivered to the cone receptors at the back of the eye via subretinal injection.
