Pfizer begins phase 3 trial as Fauci expresses optimism about vaccine schedule

The global search for a coronavirus vaccine appears to be taking off, with a number of pharmaceutical companies moving ahead with clinical trials, including a late announcement from Pfizer (PFE) entering Phase 3 with one of its candidates developed with BioNTech ( BNTX).

Progress in effective inoculation of COVID-19 comes as the virus continues to claim new victims worldwide, as the United States fights an uphill battle to contain an increase in confirmed cases. Vaccines remain the key to ending severe restrictions on public life, which include the wearing of public masks and social distancing, all of which have become a critical point in the political discourse of the United States.

However, advancement in vaccines has made Anthony Fauci, the federal government’s leading infectious disease expert, “cautiously optimistic” that a potential vaccine candidate could emerge in the late fall, he said Tuesday. In a recent Yahoo Finance interview, Fauci said the accelerated momentum “paid off” despite the inherent risks.

In a phone call Tuesday, Pfizer (PFE) CEO Albert Bourla said the company hopes to have some news and will complete the regulatory review by October 2020. The company had four potential candidates and has advanced one of those. , a 30 of two shots. microgram dose – in the final phase.

Moderna (MRNA) also announced yesterday its Phase 3 trial, which it is doing with significant funding and support from the federal government. Johnson & Johnson (JNJ) also announced its candidate’s entry into Phase 1 on Monday.

Pfizer executives told investors Tuesday that they see the pandemic as a source of recurring revenue with the vaccine becoming a seasonal necessity, like the flu, and prices adjusted accordingly. The current price of $ 19.50 is based on 100 million doses purchased at $ 1.95 billion by the federal government, and is lower than the value the company believes the drug has for society, according to Bourla.

The price has been a point of concern for some patient advocacy groups, who believe that companies should provide the vaccine at no cost.

Angela Hwang, global president of biopharmaceuticals at Pfizer, said Tuesday that the company would not offer other countries a lower price than the United States, except for the poorest countries.

“No country in the developed world will receive doses (of the COVID-19 vaccine) at a lower price than the United States.” for similar volume commitments, Hwang added.

Moving to end a ‘dangerous’ dependency

Manufacturing and logistics are proving to be the biggest hurdles the United States has to overcome to respond to the coronavirus outbreak.

This is why the U.S. Department of Health and Human Services, Through Operation Warp Speed, and the Department of Defense (DoD) have invested in various strategies to help drive U.S. production.

Shortages of protective equipment, test supplies, glass vaccine vials, and the refrigerated transport needed for vaccines are straining amid the pandemic. To date, the executive branch has funded or used the Defense Protection Act (DPA) to produce N-95 masks and fans, and other critical equipment.

It is also funding production and research for COVID-19 vaccines. That includes announcements this week to leverage Eastman Kodak (KODK) and FUJIFILM (FUJIY) with Texas A&M University for manufacturing.

According to the DPA, Kodak received a $ 765 million loan to pursue the production of generic drug active ingredients, a product that is primarily produced in offshore facilities in India and China.

Previously, HHS awarded a grant of up to $ 812 million to the startup Phlow Corporation to do the same, according to the Trump Administration’s position that the United States relies too heavily on products abroad.

“If we have learned anything from the global pandemic, it is that Americans are dangerously dependent on foreign supply chains for their essential drugs,” Peter Navarro, a White House adviser, said in a statement announcing the Kodak loan.

Separately, HHS announced a $ 265 million contract with FUJIFILM and Texas A&M to help increase the country’s vaccine production capabilities. That includes candidates like Novavax (NVAX), which recently announced a separate partnership with FUJIFILM.

Warp Speed ​​has previously given hundreds of millions for key medical supplies needs to companies like ApiJect, Corning and SiO2 Material. However, other companies are independently seeking drug production without government money., a startup like Phlow, also recognized the need for national production of drug ingredients and began addressing the problem before the global pandemic. The company partnered with Bright Path Labs earlier this year to focus on continuous manufacturing of drug ingredients.

Larry Taber, vice president of Life Sciences at Quartic, told Yahoo Finance that Bright Path had been in contact with the White House coronavirus task force to produce 25 ingredients.

“This continuous flow technology has been around for a decade and a half, but it has not been well received by the pharmaceutical industry” until a couple of years ago, Taber said.

The technology requires a smaller footprint than traditional batch manufacturing, and would take only a few months to install. A veteran pharmacist, Taber suggested that the reason it hasn’t taken off, according to Taber, is because of the existing and expensive infrastructure at those companies.

“I have brought products out of the US and I know we can bring them back … and we can make them so competitive,” he said.

reporter at Yahoo Finance. Follow her on Twitter: @AnjKhem“data-reactid =” 48 “>Anjalee Khemlani is a reporter at Yahoo Finance. Follow her on Twitter: @AnjKhem

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