Pfizer’s Promising mRNA Vaccine Is Welcome News for the Country
By: Dr. Zach Zachariah
Tags: Pfizer Vaccine, 60 Minutes, Covid 19, Covid Vaccine, FDA

Pfizer’s Promising mRNA Vaccine Is Welcome News for the Country

The daunting task is to manufacture and distribute millions of doses needed.

Photo illustration: COVID-19 image, Wikimedia Commons, Public Domain Image of Logo

On Monday, November 9, 2020, New York-based pharmaceutical giant Pfizer and its German partner BioNTech announced that their experimental vaccine maybe 90% effective against SARS-CoV-2 (the virus that causes COVID-19). The announcement was a news release, not even a preprint, and did not contain any data or analysis. The Pfizer/BioNTech vaccine, BNT162b2, is messenger RNA (mRNA) based.

According to ScienceNews, the data came from Phase 3 clinical trials. In the double-blind study, 39,000 of the 43,500 participants in six countries received two injections spaced 21 days apart of either the vaccine or a placebo. Pfizer conducted the interim efficacy study after 94 participants developed COVID-19. Fewer than nine of them received the vaccine. Given the estimate that the vaccine is 90% effective, it is safe to assume very few people who were vaccinated got Covid-19.

To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers; a number that the Food and Drug Administration (FDA) has agreed is enough to tell how well the vaccine is working. Outside experts caution that lacking critical details in the news release; we still do not know how safe the vaccine would be for different age groups. A longer-term study is needed to assess the side effects and other complications.

Moderna, another biotech company developing its mRNA-based vaccine, is expected to release Phase 3 clinical trial data in the coming days. These two announcements, coming days apart, are welcome news to the country reeling with another COVID-19 surge with a record number of new cases (181,194 on Friday) and deaths (1,389). There are currently 68,516 patients hospitalized, of which 13,132 are in ICU and 3,789 on ventilators. (Data Source: Covid Tracking Project).

The old-fashioned approach to vaccine development was to use a weakened or inactivated virus. This process was employed to develop polio and measles vaccines. An article published in the Journal of American Medical Association explains that a person receives part of the coronavirus's genetic code in mRNA vaccines, tricking the body into producing some viral proteins. The body’s immune system can then detect these proteins and create a defensive response to them.

Pfizer/BioNTech and Moderna plan to apply to the FDA for emergency approval to use the vaccine by the end of November or early December. By then, they will have two months of safety data on about half of trial participants, which raises the possibility of a regulatory decision sometime in December.

Unlike Moderna and AstraZeneca, Pfizer did not accept federal funding to help develop the vaccine. They made a deal with the government to deliver 100 million doses of the vaccine and got $1.95 billion. This deal was just an advance-purchase agreement, and the company will receive the money only when they deliver the vaccine. During his first public remarks on Friday, President Trump tried to take full credit for Pfizer’s announcement of its COVID-19 vaccine, which is false based on the facts described above.

What is Operation Warp Speed?

Operation Warp Speed is a public-private sector initiative by the U.S. government that has pledged $10 billion to develop, manufacture, and distribute a safe and effective COVID-19 vaccine.

The graphics above illustrates the various stages of the accelerated process envisioned by Operation Warp Speed. The vaccine development process involves identifying candidates through R & D, followed by pre-clinical and then clinical trials. Typically the whole process used to take six or more years. This accelerated process proposes to shrink the timeframe to 14 months.

One of CBS’s 60 Minutes segments on Sunday, November 8, 2020, was on Operation Warp Speed. David Martin interviewed General Gus Perna, the chief operating officer, and Lt. General Paul Ostrowski, his deputy. He also talked to the Vice President Sean Kirk of Emergent BioSolutions in Baltimore, which has already begun manufacturing the vaccines. Another person interviewed was Karen Flynn of Catalent, whose job is to fill the large batches into vials.

With experience as Commander of the Army’s Materiel Command, General Gus Perna is well qualified to oversee the logistical operations. He had to build the whole operation from scratch because the government had “no doctrine, no strategy, and no structure of people.”

Pfizer and other companies are now completing the clinical trials. General Perna’s tasks are to oversee:

Manufacture sufficient quantities of the vaccine Supply chain management Logistics

When the first shipment is ready, and the general gives the command, “Execute,” he wants the vaccine to get to its destination in 24 hours. That is warp speed indeed.

Manufacturing

Emergent BioSolutions in Baltimore is manufacturing the vaccine in bio-reactors inside their sterile facilities. It takes up to six weeks to produce a single batch. From there, it moves to a facility run by a company called Catalent, where it gets filled into vials ready for injection. This facility can bottle 400 vials per minute and is running 24/7.

Stockpiling

The medical distribution company, McKesson, says it already has produced enough kits for 88 million shots. Operation Warp Speed is also stockpiling kits of the needles, syringes, and alcohol swabs, who will send the kits and the vaccine together.

Storage

The Pfizer vaccine needs to be stored at -70 to -80 degrees Celsius (94 degrees below zero Fahrenheit). The need for ultra-low temperature is going to be a significant logistical challenge. Most places, including hospitals, can only refrigerate at around -2 to -8 degrees. At this temperature, the vaccine can stay active only up to 5 days.

Reuters has reported that the cold storage requirements could impede Pfizer’s ability to reach rural healthcare systems and nursing homes. Wealthier parts of the country already have ultra-cold freezers. California has proposed building a distribution network of ultra-cold freezers, including mobile vaccination clinics, to reach underserved areas of the state.

If Pfizer receives authorization for its vaccine from the FDA in the coming weeks, vaccine distribution may begin as early as January. The initial doses will go to frontline workers in the healthcare system, including nursing homes, and then to elderly residents in long-term care facilities. It will be several months before the general public can expect to receive the vaccine.

Would people resist the vaccine?

Because of the politicization of the vaccine by President Trump before the election, people were skeptical of any vaccine promoted by him. Judith Perisichelli, New Jersey Health Commissioner, who was also interviewed by David Martin, talked about a survey of 2,000 health care individuals, physicians, and nurses. According to the Commissioner, while 60% of physicians said they would get the vaccine, only 40% of the nurses said they would. If the frontline personnel are skeptical, only a smaller percentage of the general public would be willing to line up.

The final comments by General Perna were sobering: “We get vaccines to the American people, and they don’t take them. Shame on us.”