2021 COVID-19 News: Pfizer to File for Full Approval of Its Vaccine and More

CV Update_May 4_2021

News information is not all-inclusive and updates are published once a week on Tuesdays.

Here's a look at some of the top COVID-19 news over the past week. 

In a quarterly earnings report, Pfizer said they plan to file for full FDA approval of its COVID-19 vaccine. The plan is to file by the end of May and if approved, the company can market directly to consumers. 

The U.S. Food and Drug Administration (FDA) is expected to give the go-ahead for Pfizer and BioNTech’s COVID-19 vaccine for adolescents ages 12 and older within the week. The Pfizer-BioNTech vaccine is already authorized for people age 16 and older. About a month ago, the companies reported that the vaccine was safe and effective for younger people.

Eli Lilly will donate COVID-19 therapies to Direct Relief, to help provide at no cost or low cost to low and lower-middle-income countries.

Next year, people are likely to need an annual COVID-19 vaccination just like they need an annual flu shot. That prediction is made by researchers at six of Australia’s leading medical research institutions, based upon their study of the levels of neutralizing antibodies needed to confer protection against COVID-19. The detailed paper appeared in a medRxiv preprint.

Battered by vaccine manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine, Emergent BioSolutions is shaking up its leadership to ensure such errors do not occur again.

AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth. Announcing in March a mid-April submission for U.S. approval, that timeline has been pushed back to mid-May, with the company citing the massive dataset as the cause.  

A study out of RCSI University of Medicine and Health Sciences and the HSE Health Protection Surveillance Centre (HPSC) in Ireland has further defined the association between comorbidities and poor outcomes with COVID-19. The study took place between March and July 2020 and collected national data in Ireland from both hospital and community settings. It collected data for almost 20,000 confirmed cases of COVID-19. The results were published in The Lancet Regional Health – Europe.

Researchers with Mount Sinai Hospital and Mount Sinai School of Medicine tested a combination of Gilead’s remdesivir, an antiviral drug, with repurposed drugs for hepatitis C virus (HCV). The combinations, they found, were 10-times more effective at inhibiting SARS-CoV-2, the virus behind COVID-19.

India is now the epicenter of the COVID-19 epidemic. Every day for an entire week the country reported an average of 340,000 new COVID-19 cases. This comes to one in every three infections reported globally per day. Feeding the surge in India is what is being dubbed a "double mutant" variant, B.1.617, which had two key mutations observed in other coronavirus variants. It has also been identified in other countries, including the U.S.

Moderna, one of three companies to have a COVID-19 vaccine authorized in the U.S., isn’t resting on its accomplishments but is instead working to scale up production further and improve on its vaccine. Moderna has indicated it is working on new formulations that could extend the refrigerated shelf life. New data from the company also supports the vaccine could be refrigerated safely for three months.

Novartis AG Chief Executive Officer Vas Narasimhan believes that the hybrid of remote and on-site office work is the future. The Swiss pharma giant’s CEO said this will open up the possibility of working with new pools of talent that were inaccessible pre-COVID pandemic.

The CDC just relaxed social distancing guidelines for vaccinated people, and experts say the U.S. should achieve herd immunity to COVID-19 by the summer. As humans, when we begin to see a light at the end of the tunnel, we naturally look for the next crisis and spend a lot of time anticipating how we might go about being better prepared. Read more on preparing for the next pandemic. 

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