Eight months after development of its Covid-19 vaccine began, Pfizer officially filed for emergency approval with the U.S. Food and Drug Administration on Friday. https://www.npr.org/2020/11/20/937026003/pfizer-asks-fda-to-approve-its-covid-19-vaccine-for-emergency-use

“Submitting an emergency permit in the US is a critical step in making our vaccine candidate available to the world’s population as soon as possible,” said Dr. Ugur Sahin, CEO of BioNTech, in a joint statement released by the companies, told NPR. “We intend to continue working with regulators around the world to enable the rapid spread of our vaccine worldwide.”

Pfizer chairman and CEO Albert Bourla, DVM, told NPR Thursday that the company expects to produce enough vaccines to vaccinate 25 million people by the end of the year. Approximately 12.5 million of the starting doses will be for the US, with the remaining half going to the rest of the world.

Also this week, Moderna announced that its vaccine candidate has shown in preliminary results that it is more than 90% effective against the coronavirus. Both the Pfizer and Moderna vaccines are two doses per patient and must be refrigerated, the Pfizer vaccine at minus 70 degrees Celsius or colder than winter in Antarctica. Moderna’s vaccine needs to be chilled to minus 20 degrees Celsius, which is roughly the temperature of a normal freezer.

Other vaccine hopefuls that have reached the final stage of their trials include Janssen Pharmaceutical Companies of Johnson & Johnson and Oxford University-AstraZeneca. Interim data from the Oxford vaccine showed it elicited an immune response in older and younger adults.

As welcome as the news from Pfizer and Moderna is, a large proportion of Americans still weren’t sure about the safety of the vaccines. Health officials estimate that 70% of the population would need to be vaccinated to stop the rampant spread of Covid-19. A recent Gallup poll found that only 58% of Americans were willing to get vaccinated. People are concerned that such a rapidly developed vaccine has been sacrificed.

APIs no longer in our midst

In the past, the medicine was made in the United States. But that has changed in the last few decades. Most of the drug ingredients are manufactured overseas. They are referred to as active pharmaceutical ingredients or active ingredients. APIs are the actual drugs that are formulated in tablets, capsules, and injections

New York-based Pfizer plans to manufacture its vaccine in three locations in the United States and Europe. Moderna has announced that it will manufacture its vaccine and ingredients in the US and Switzerland, where its partner Lonza is located.

AstraZeneca has a manufacturing agreement with Catalent. According to Catalent, manufacturing will take place in Maryland and at the AstraZeneca site in Italy. Catalent also assists Johnson & Johnson and Moderna with their manufacturing requirements.

Inspections

Regardless of where APIs or finished drugs come from, they must meet all FDA legal and regulatory standards for safety, quality, and effectiveness in manufacturing processes for over-the-counter and prescription drugs. While this is not a mandate for a new drug to be approved, FDA inspections of the manufacturing facility are often performed prior to approval of the drug. The purpose of these inspections is “to help the FDA know that a facility identified in a drug application is capable of manufacturing a drug and that the information submitted is accurate and complete.”

In its August guidance on temporarily suspending inspections of facilities during the pandemic, the FDA said it would use other “tools” such as: B. reviewing a company’s previous compliance history. [and] Use of the information exchange between trustworthy foreign regulatory partners through mutual recognition. ”

US drugs everywhere

Janet Woodcock, MD, director of the Center for Drug Evaluation and Research (CDER) for the Food and Drug Administration, told the subcommittee in her October 2019 testimony to the House of Representatives Subcommittee on Health that only 28% of the manufacturing facilities were made for APIs Supplies to the US market were domestic.

In contrast, the remaining 72% of API manufacturers serving the US market were overseas and 13% were in China, “said Dr. Woodcock.

Besides China, 28% of the active ingredients come from the European Union (26%), India (18%), Canada (2%) and 13% from the rest of the world. Dr. Woodcock said the number of Chinese companies making APIs for the American market has increased over the past decade. However, the FDA has not been able to calculate how many active ingredients are used in US-marketed medicines from China or India, or what percentage of US drug use they make up.

“We don’t know if Chinese facilities actually produce APIs, how much they produce, or where the APIs they produce are sold worldwide, including in the US,” she told the subcommittee.

Mary Denigan-Macauley, GAO director of health care, testified before the Senate Finance Committee in June 2020 that Covid-19 had brought America’s reliance on overseas drug manufacturers and the pharmaceutical supply chain to the fore.

“Like most other drugs made for the US market, much of the manufacturing of drugs used to treat COVID-19 is done overseas,” she told the committee.

Ms. Denigan-Macauley said FDA data showed that 70% of the companies that make APIs and 50% of those that make finished drugs for the U.S. market are based overseas. Of all foreign companies that ship drugs to the US, 40% were responsible for India and China.

According to her, FDA inspectors faced several challenges when conducting overseas inspections. In America, FDA inspections almost always arrive unannounced. However, overseas manufacturers know up to three months in advance of an upcoming inspection, giving them plenty of time to fix quality control issues and fix production issues.

Ms. Denigan-Macauley acknowledged that since the GAO began investigating the issue in 2009, the FDA has made important changes in adapting to globalization of the pharmaceutical supply chain. Still, the agency faces many challenges in monitoring foreign drug manufacturers.

“Since then, the COVID-19 outbreak has added complexity,” she concluded. “It also highlights the global nature of our pharmaceutical supply chain.”

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