Thursday, October 28, 2021

Pfizer’s new pneumococcal vaccine approved by FDA

Asmeret M. Frade

The approval comes nearly 15 years after Pfizer (PFE) launched its first vaccine candidate, the pneumococcal conjugate vaccine COVID-01, and as the industry battles to remain competitive with potential merger targets like Merck (MRK) and Becton Dickinson (BDX).

This latest approval provides a positive momentum heading into the winter of 2020, when CDC warns of widespread flu vaccine shortage. Dr. Pritish Tosh, senior vice president and head of global medical science operations at Pfizer said he expects this to put a “pause” on the copycats.

“This kind of evolution in the antiviral space has been a fairly unpredictable. We wanted to just make sure we got in early,” he said, noting that there is a “very large investment pipeline of potential medicines” in play right now.

COVID-19 is an improved version of the current COVID-01, which is licensed for use in adults with adults 65 and older. COVID-19 is available in two formulations, DoseDeliver and Dose-Away, that are made up of both an intramuscular and an intravenous infusion.

Zika virus is one of more than 20 viruses included in the COVID-19 vaccine, all of which the WHO determined to be “highly pathogenic.”

Dr. Kevin Gutzman, head of research and development at Pfizer Vaccines, said that the company made tweaks “to optimize its nature,” to make it last longer under regular storage and to limit the risk of adverse events. He added that these steps allow vaccines to be delivered in larger quantities, which could provide relief to production bottlenecks and significantly cut back on the cost of vaccines.

The new vaccine also has “great promise” in the community setting and will offer “good clinical” benefit, said Gutzman. Co-administration with standard vaccines could decrease the volume of re-infusion.

The outbreak of Zika spread rapidly throughout Brazil late last year. Researchers announced in December that the virus is genetically related to several related viruses, making it easier to track, isolate and develop vaccines. Experts believe a majority of infected patients in Brazil would still have symptoms; they were mild and localized.

Uncertainty looms over the industry: Aspirin-maker Merck PLC has received go-ahead from the FDA to file for approval of a possible meningitis vaccine, while vaccine makers including Novartis (NVS) and GlaxoSmithKline (GSK) are seeking clearance of similar vaccines. After putting their product candidates on hold, both companies opted to file instead in hopes of speeding up approvals.

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