Five important questions about Pfizer’s COVID vaccine

Arthur Allen

Wednesday, November 11, 2020 (Kaiser News)-The COVID-19 shot released by Pfizer on Monday does not appear to allow 9 out of 10 people to spike stock prices. Many news reports vaccine As if it were our rescue from PandemicAlthough little details have been announced.

Certainly something rang: Pfizer’s vaccine It is composed of a genetic material called mRNA that is wrapped in small particles that shuttle it to our cells.From there, it stimulates Immune system To make antibodies that protect against viruses.A similar strategy has been adopted by other major COVID-19s. vaccine candidate. If the mRNA vaccine can protect against COVID-19 and possibly other infectious diseases, that would be significant news.

“This is truly the first in history,” said Dr. Michael Watson, former president of Valera, a subsidiary of Moderna, which is currently conducting advanced trials of its own mRNA vaccine against COVID-19. “We now have a whole new class of vaccines.”

But historically, important scientific presentations about vaccines have been made not through corporate press releases, but through peer-reviewed medical research papers that have been extensively scrutinized for study design, results, and assumptions.

So is Pfizer’s share price worth a double-digit rise? The answers to the following five questions will help us to know.

1. How long does the vaccine protect the patient?

As of last week, Pfizer said 94 of the approximately 40,000 people in the trial were infected with COVID-19. The exact number of vaccinated illnesses was not known, but the 90% efficacy figure suggests that it was very small. Pfizer’s announcement is aimed at people who took two shots between July and October. However, it does not indicate how long the protection lasts or how often people may need boosters.

“It’s a reasonable bet, but it’s still a bet that a couple of months of protection is similar to a six-month or one-year bet,” said Dr. Paul Ofit, a member of the Food and Drug Administration panel. .. December approval. Vaccines are usually not approved until they are shown to be protected for a year or two.

The company did not release safety information. To date, no serious side effects have been identified and most tend to occur within 6 weeks of vaccination. However, scientists need to pay attention to rare effects such as immunization, serious illnesses caused by the interaction of the virus with the immune particles of some vaccinated people, Emory University. Dr. Walt Orenstein, a professor of medicine and former director of Emory University, gave an overview of the vaccination program at the Centers for Disease Control and Prevention.

2. Do you want to protect the most vulnerable?

Pfizer did not reveal what percentage of trial volunteers were among people over the age of 65 and the group most likely to die of COVID-19. Diabetes Or obesity.. This is an important point.Because many vaccines, especially influenzaProtects young people, but may not protect older people. “How representative are the 94 people in the total population, especially those at greatest risk?” Orenstein asked.

Both the National Academy of Medicine and the CDC are encouraging older people to be one of the first groups to be vaccinated. The vaccine being developed by Novavax and Sanofi is likely to begin late-stage clinical trials later this year, so it could be better for the elderly, Ofit said.These vaccines contain immunostimulatory particles like those contained in Shingrix A very effective vaccine to prevent the elderly Herpes zoster disease.

3. Can it be deployed effectively?

Pfizer vaccines, unlike other vaccines in late-stage studies, need to be supercooled on dry ice at about 100 degrees below freezing from the time of manufacture until a few days before injection. mRNA quickly self-destructs at high temperatures. Pfizer has devised an elaborate system for trucking vaccines and a specially designed case at the vaccination site. As we’re talking, public health workers are trained to handle vaccines, but we don’t know how well they will work if the container is left in the sun in Arizona for too long. Hmm. Mishandling the vaccine on the way from the factory to the patient will invalidate the vaccine, and people who receive the vaccine may think they are protected otherwise, Ofit said.

4. Can premature announcements hurt future vaccines?

Currently, there is no way to know if the Pfizer vaccine is optimal overall or for a particular age group. However, if the FDA approves it quickly, it can make it difficult for other vaccine manufacturers to carry out the study. If people know that an effective vaccine exists, they may refuse to participate in clinical trials, partly concerned that they may get a placebo and remain unprotected. .. Indeed, the use of placebo in such trials may be unethical. It is important to continue additional research as many vaccines are needed to meet the global demand for protection against COVID-19.

5. Can Pfizer’s research promote future vaccines?

Scientists are very interested in whether a small number of people who have been vaccinated with real vaccination but are still ill have produced lower levels of antibodies than vaccinated individuals who remain healthy. I have. Blood studies of those people help scientists know if there is a “protection correlation” for COVID-19 — the level of antibodies that can predict whether someone is protected from the disease. If they had that knowledge, public health authorities could determine if other vaccines in production would be effective without necessarily having to test them with tens of thousands of people. It was.

However, it is difficult to create such a roadmap.Scientists have never established an immune correlation Whooping coughFor example, vaccines have been used against these bacteria for almost a century.

Still, this is good news, said Dr. Joshua Schaffstein, vice president and former FDA vice chairman of the Johns Hopkins Bloomberg School of Public Health. He states: Hope will come, whether this vaccine or another. “

This KHN story was first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. This is an editorial independent program of the Henry J. Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.