In March 2020, Pfizer, Eli Lilly, Bristol-Myers Squibb, and Provention Bio were among a host of pharma companies to announce they had postponed some of their clinical trials to focus on the novel coronavirus. The postponement of these pre-clinical development projects has led to disruptions in pharma supply chain activity and production.
This week’s pharma round-up dives into how demand for antibiotics is increasing despite pharma’s shifted focus and highlights positive news from Johnson & Johnson’s (J&J) single-dose vaccine which has been authorized for emergency use in the US.
FDA deems Johnson & Johnson’s single-shot vaccine as safe and effective
The US Food and Drug Administration (FDA) has found J&J’s single-use Covid-19 vaccine to be safe and effective. J&J submitted the application to the FDA requesting Emergency Use Authorization (EUA) for its investigational single-use candidate in February 4, 2021, and has received a positive outcome that may allow the company to become the third Covid-19 vaccine to be authorized in the US.
Paul Stoffels, vice-chairman of the executive committee and chief scientific officer at J&J, said: “The submission for EUA of our investigational single-shot Covid-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”
Separately, J&J has started to roll out the single-use vaccine in South Africa after the results from its clinical trial showed the drug to be 72 percent effective in the US and 66 percent effective overall at preventing moderate to severe Covid-19, 28 days after vaccination.
The single-use vaccine is being administered in South Africa as part of a research study following South Africa pausing its roll out of AstraZeneca’s vaccine. The J&J shot has shown to have approximately 57 percent efficacy in preventing Covid-19 infections in South African trials, whereas AstraZeneca’s vaccine has not shown to have as effective results at this point in the study.
“Upon authorization of our investigational Covid-19 vaccine [in the US], we are ready to begin shipping,” Stoffels said. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
J&J has initiated rolling submissions with several other health agencies outside the US, and will submit a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks.
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Antibiotics market estimated to reach $8bn by 2021
A pharmaceutical market report by Future Market Insights uncovered the demand for antibiotics has risen year-on-year and will continue to rise at a steady pace between 2021 and 2031, despite the Covid-19 pandemic causing market disruption.
With antibiotics often used as a primary treatment option to treat bacterial infections, large pharmaceutical companies are expected to dominate 77 percent of all antibiotic sales to tackle pneumonia, which is the single largest infectious cause of death in children worldwide according to the World Health Organization (WHO).
The antibiotics market is likely to surpass $8.1bn in 2021 and continue to climb in value despite the Covid-19 pandemic causing pharma companies to shift focus and resources from making other drugs to Covid-19 vaccines, the report highlighted. The shortage of various active pharmaceutical ingredients (API) and restricted hospital visits due to the increasing pool of Covid-19 patients are some of the key barriers that jolted global antibiotics market growth in 2020.
Following initial API supply disruptions due to the pandemic, Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, said: “The pharma industry needs to become more self-reliant in the production of APIs, so not to disrupt other markets in pharma, but it will take some time to achieve this goal. The fundamental goal is to diversify the supply chain. Every manufacturer cannot be dependent on a single supply source.”
The report’s authors said: “While we have seen some disruption in the antibiotics market, there is still increasing prevalence of bacterial diseases around the world, extreme uses of antibiotics and rising investment in research and development around advanced molecules, which are all major factor expected to boost the growth of the antibiotics market for many more years to come.”
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