FDA Pauses Inovio’s Vaccine Trial

Reuters: U.S. FDA Pauses Inovio's Coronavirus Vaccine Trial Plan 
The U.S. health regulator has put a hold on Inovio Pharmaceuticals's plans to start final trials of its coronavirus vaccine as the agency seeks more information, including details on a delivery device used to inject genetic material into cells. The mid-to-late trials, which were awaiting approval from the U.S. Food and Drug Administration, were scheduled to start this month after they were postponed from this summer. (9/28)

The Wall Street Journal: Inovio Covid-19 Vaccine Trial Placed On Hold After FDA Questions 
A planned later-stage trial for a Covid-19 vaccine from Inovio Pharmaceuticals Inc. is on hold, after U.S. health regulators raised questions, the company said. The delay means the Phase 2/3 trial for Inovio’s experimental vaccine won’t begin until October at the earliest. Inovio shares fell as much as 33% on Monday after the trial hold was announced. The stock was down nearly 30% in the midmorning. Through Friday’s close, the stock price had soared more than 400% this year. (Hopkins, 9/28)

In other vaccine news —

Politico: Top FDA Vaccine Official Says Vaccine Guidance May Never Be Released 
White House objections may prevent FDA from releasing stricter guidelines it has drawn up for the emergency authorization of coronavirus vaccines, the agency's No. 2 vaccine official said Monday. Nevertheless, the FDA wants vaccine developers to know that it will insist on seeing through clinical trials for any shot that receives emergency authorization, said Phillip Krause, deputy director for the FDA's Center for Biologics Evaluation and Research. (Brennan, 9/28)

FiercePharma: Pfizer Urged To Hold Off On Coronavirus Vaccine Until Late November: Report 
Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said the companies expect phase 3 data by the end of October—and that an FDA application could soon follow. But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light, Bloomberg reports. The experts called on Pfizer to wait until late November at least to submit its vaccine to the FDA. That would give trial investigators enough time to compile at least 2 months of safety data after participants receive their second doses. Pfizer, for its part, has said it expects to know by the end of October whether its program works. (Sagonowsky, 9/28)

The Atlantic: COVID-19: The Most Complicated Vaccine Campaign Ever 
On the day that a COVID-19 vaccine is approved, a vast logistics operation will need to awaken. Millions of doses must travel hundreds of miles from manufacturers to hospitals, doctor’s offices, and pharmacies, which in turn must store, track, and eventually get the vaccines to people all across the country. The Centers for Disease Control and Prevention, along with state and local health departments, coordinates this process. These agencies distributed flu vaccines during the 2009 H1N1 pandemic this way, and they manage childhood vaccines every day. But the COVID-19 vaccine will be a whole new challenge. (Zhang, 9/28)

The Hill: WHO Says Mass Vaccinations Probably Won't Happen Until Summer 2021 
Large-scale doses of a COVID-19 vaccine most likely won’t be available to the public until summer 2021, the World Health Organization (WHO) said Sunday. USA Today writes that WHO Chief Scientist Soumya Swaminathan told reporters that the ideal vaccine candidate will only require one shot and last for several years. "By the time people start getting the vaccine ... it would be somewhere in the middle of 2021," she said on Sunday. (Kelley, 9/28)

Reuters: Russian Scientist Behind COVID-19 Vaccine Defends 'Wartime' Roll-Out 
Russia plans to share preliminary results of its COVID-19 vaccine trial based on the first six weeks of monitoring participants, raising the tempo in an already frenzied global race to end the pandemic. Alexander Gintsburg, head of the Gamaleya Institute that produced the Sputnik V vaccine, told Reuters that the pace of its development was necessary under the “wartime” conditions of a pandemic but no corners were being cut. (Nikolskaya and Ivanova, 9/29)

Also —

Miami Herald: 500,000 Sharks May Have To Die In The Fight Against COVID-19. Here’s Why
A nonprofit organization estimates about 500,000 deep-sea sharks may need to die to supply the world with a coronavirus vaccine when one proves safe and effective. A shark’s liver contains oil primarily made up of a compound called squalene, which can also be found in plants and humans. It’s largely known as a moisturizing agent in cosmetics such as skin creams and lip balms, but squalene is also used in some adjuvants — common ingredients in vaccines that help create a stronger immune response. (Camero, 9/28)

Science Times: Developing Coronavirus Vaccines Are Harming Shark Species 
Wildlife experts worry over shark populations that are in danger as international companies continue to develop coronavirus vaccines. Sharks produce squalene, a substance in their livers, which is harvested as an ingredient for vaccines such as influenza and malaria vaccines. Human livers also produce squalene, which naturally runs in the bloodstream, and can also be found in plants and other animals. Commercially, it can be extracted from fish oil and most commonly from shark liver oil. Sharks have more oil in their livers as it helps regulate their buoyancy in deep waters. (9/28)