COVID vaccines appear safe and effective, but key questions remain



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The recent launch of two recently licensed COVID-19 vaccines is a bright ray of hope in the pandemic’s darkest hour.

We now have a path that can lead us to happier times, even as we watch and suffer the horrible avalanche of new infections, hospitalizations and deaths that mark the end of this regrettable year.

Health workers and nursing home residents have already started receiving vaccines in the first phase of the launch. Vaccines should begin to be available to the general public in the first few months of next year.

The two vaccines, one developed by Pfizer and BioNTech, the other by Moderna, use the same novel genetic approach. Its development in less than a year, breaking all records, is a marvel of science. It is also a cause for concern for millions of Americans who fear the uncertainty of unknown technology.

Clinical trial data for the Pfizer and Moderna vaccines show that when both injections of the double-shot immunization are taken, three weeks to one month apart, they are approximately 95% effective, at least in preventing severe COVID illness.

However, “a vaccine that stays in the vial is 0% effective no matter what the data shows,” says Dr. Walter Orenstein, professor of infectious diseases at Emory University School of Medicine in Atlanta and associate director of the Emory Vaccine Center. .

Hence the imperative to persuade millions of people, of all races, cultures, religions, politics and generations to get vaccinated when they have a vaccine. A survey released this month showed 45% of respondents are taking a wait-and-see approach to vaccination.

Because vaccines were developed under pressure when the coronavirus took its deadly price, the premium was on speed – “warp speed.” So even though the number of people in the trials is as large or greater than in previous vaccine trials, some key questions won’t be answered until millions more are vaccinated.

For example, we do not know to what extent vaccines will prevent us from transmitting or contracting the virus, although the protection against life-threatening diseases that they probably confer is itself something of a miracle.

We do not know if irreversible side effects could arise or who is most at risk for them. And we do not know if we will have to get vaccinated every year, every three years or never again.

These unknowns add to the challenges faced by the federal government, local health authorities, medical professionals and private sector entities as they seek to persuade people from the widest possible swath of the population to get vaccinated.

Skepticism resides in many quarters, including African Americans, many of whom have long distrusted the medical world; the vocal “anti-vaccines”; and people of all kinds with perfectly understandable doubts. Not to mention the language barrier and undocumented immigrant communities, more than 2 million in California, who may fear showing up.

Here are answers to some questions you may be asking about the new vaccines:

Q: How can I be sure they are safe?

There is no guarantee of iron. But the federal Food and Drug Administration, in licensing the Moderna and Pfizer vaccines, determined that their benefits outweighed their risks.

Side effects seen in trial participants were common to other vaccines: injection site pain, fatigue, headache, muscle pain, and chills. “Those are minor side effects, and the benefit is not dying from this disease,” says Dr. George Rutherford, a professor of epidemiology at the University of California-San Francisco.

On Saturday, the Centers for Disease Control and Prevention reported six cases of anaphylactic allergic reaction in the first 272,000 people who received the Pfizer vaccine outside of clinical trials. This has led the CDC to recommend that people who receive the vaccine be observed for up to 30 minutes later.

Other unexpected side effects may appear in the future. “The chances are low, but not zero,” says Orenstein. There is not yet enough data to know whether vaccines pose a high risk for pregnant or lactating women, for example, or for people who are immunosuppressed, such as those with HIV. And we know very little about the effects in children, who were not in the initial trials and for whom vaccines are not licensed.

Q: Why should my family and I take it?

First of all, because they will protect themselves from the possibility of serious illness or even death. Plus, by getting vaccinated, you are doing your part to achieve a high enough vaccination rate to end the pandemic. No one knows exactly what percentage of the population needs to be vaccinated for that to happen, but infectious disease experts put the figure between 60% and 70%, perhaps even slightly higher. Think of it as a civic duty to get your shots.

Q: So when can I get mine?

It depends on your health, age and job status. In the first phase, which is already underway, health workers and residents of nursing homes are vaccinated. The 40 million doses of Moderna and Pfizer expected to be available by the end of the year should immunize most of them.

Next in line are those 75 and older and essential workers in various public jobs. They will be followed by people 65 to 74 and under 65 with certain medical conditions that put them at high risk. Enough vaccines may be available for the rest of the population in late spring, but summer or even fall is more likely. Some distribution bottlenecks have already developed.

On the bright side, two other vaccines – one from Johnson & Johnson, the other from AstraZeneca and the University of Oxford – could gain FDA clearance early next year, significantly increasing supply.

Q: Once I’m vaccinated, can I finally stop wearing a mask and physical distancing?

No. Especially not at the beginning, before many people have been vaccinated. One of the reasons is self-protection. The Moderna and Pfizer vaccines are 95% effective, but that means you still have a 5% chance of getting sick if you are exposed to someone who has not been vaccinated, or who has been transmitting the virus but still is.

Another reason is to protect others, as you could be the one to release the virus despite vaccination.

Q: I already had COVID-19, so I don’t need the vaccine, right?

We don’t know for sure how long exposure to the virus protects you from reinfection. Protection will likely last at least a few months, but public health experts say it’s a good idea to get vaccinated when your turn comes, especially if it’s been many months since you tested positive.

There has been talk among health officials to push those who have been infected in the past 90 days to the end of the line, to ensure an adequate supply for those who might be at higher risk.

Q: How long will it be before our lives return to normal?

“If all goes well, next Thanksgiving could be almost normal and we could be getting closer to that for the summer,” says Dr. William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine at Nashville, Tennessee. “But there would have to be substantial acceptance of the vaccine and data showing that the virus is moving in a downward direction.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization not affiliated with Kaiser Permanente.

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