COVID-19 vaccinations underway across US

The vaccinations came just three days after the Food and Drug Administration (FDA) authorized emergency use of Pfizer’s vaccine, which has been found to be 95% effective and is one of several being developed to help stop the spread of COVID-19.

Pfizer developed the vaccine with German partner BioNTech. With initial supplies limited, the vaccine will be rationed for those who need it most. There could also soon be another option available in the United States.

Moderna’s COVID-19 coronavirus vaccine candidate, mRNA-1273, may be reaching patients soon. The FDA's Vaccines and Related Biological Products Advisory Committee will meet Thursday to discuss its EUA.

According to the FDA, data included in a review supports Moderna’s assessment that its vaccine had an efficacy rate of about 94.1 percent in a trial of 30,000 people.

It is expected that at least 40 million does, enough to vaccinate 20 million people, could be available from both companies by the end of the year. The nation’s 21 million health care workers and three million mostly elderly people living in long-term care facilities will go first, according to reports.

This week’s vaccinations also kicked off what is seen as a new phase in the fight against COVID-19, and they began as the United States passed the grim mark of 300,000 deaths and recorded more than 200,000 new infections in a single day

As the vaccine is distributed across the country, ophthalmologists and clinic staff likely will be among the first to be receiving shots.

Peter J. McDonnell, MD, chief medical editor of Ophthalmology Times,® and director of the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, noted that there are some variations from state to state — and even from hospital to hospital —in determining who receives the vaccine.

In Maryland, where McDonnell is located, the initial doses have been split between assisted living facilities/nursing homes and medical centers.

“At Hopkins, the first priority for the vaccine are physicians, nurses, and staff who work in the ICUs, inpatient areas and emergency rooms taking care of the COVID-19 patients,” he said. “Those of us who work in ambulatory clinics are going to have to wait until this first group of people are offered the vaccine and either are vaccinated or decline to have it.”

McDonnell noted that under the EUA from the FDA, patients must consent to have the vaccine, so it is not mandatory.

“With the approval of the Moderna vaccine expected before the end of this month, my hope is that there will be adequate supplies of vaccine to allow the first of the two doses of vaccine for ophthalmologists and their staff who choose to have it before the end of January,” he said.

With vaccinations commencing, McDonnell added that it is “the proverbial light at the end of the tunnel.”

“Because we have seen patients who have developed permanent vision loss due to a delay in care when the patients were afraid to come to their doctors’ offices earlier this year, it is important that we are able to help the population at risk for vision loss from retinal disease, glaucoma, etc. feel it is safe to see their ophthalmologist,” he said. “The vaccine will be a major step in that direction for our patients, many of whom are at high risk due to their age, and diabetes.”

With vaccinations starting, and more vaccines expected to gain approval, Americans are hopeful. McDonnell said he should be counted amongst the hopeful group.

“The creation of these remarkably effective vaccines on such a rapid timetable is a tribute to the scientists involved and the corporations that have been able to carry out the studies and ramp up production so quickly,” he said. “It will be wonderful when the front line nurses, doctors, respiratory therapists, etc., can themselves be protected from the disease.”

McDonnell said it will take some time for many Americans to begin to feel completely comfortable being amongst large groups or taking long flights, and there will be things learned during the pandemic that will persist, such as working and lecturing remotely.

“As large number of individuals are vaccinated and we have more data regarding any delayed adverse events, hopefully those individuals who may currently be afraid to receive the vaccine will elect to receive it, especially if they have comorbid conditions, and we will achieve the goal of ‘herd immunity,’” he said. “I will also be happy for those who will finally be able to have their weddings after postponements of almost a year. Life is short and having celebrations like weddings once again will be good for our collective psyche.”

William W. Culbertson, MD, professor of ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, noted that ophthalmologists and staff at Bascom Palmer began receiving vaccinations on Dec. 15.

“Although we are not front line healthcare providers, we all see patients face to face at the slit lamp and in surgery so we have all been at substantial risk until we get vaccinated,” he said. “Interestingly, we have experienced very few colds over the last 9 months that we have been wearing masks so we may continue wearing masks to see patients even after the pandemic is over.”

Culbertson said he expects to see a spike in demand of ophthalmic services going forward.

“There will be pent-up demand for routine cataract surgery that has been deferred by patients during the pandemic,” he said. “We will need to address this need but we want to get our entire staff vaccinated ASAP to feel comfortable working at full capacity.”

Uday Devgan, MD, FACS, who is in private practice at Devgan Eye Surgery in Los Angeles and Beverly Hills, and is a clinical professor of ophthalmology at the Jules Stein Eye Institute at the UCLA School of Medicine and Chief of Ophthalmology at Olive View-UCLA Medical Center, noted that he is cautiously optimistic about 2021.

“The vaccine will help to a large extent, however I still expect to be wearing an N95 mask and taking heightened precautions for most of 2021,” he said. “My outlook for 2021 is cautious optimism while tempering my expectations.”

FDA officials also are recognizing the significance of the first EAU and vaccinations.

In a statement after the EUA was granted, FDA Commissioner Stephen M. Hahn, MD, noted it marked a significant milestone in battling the pandemic, which has affected so many families in the United States and around the world.

“(This) action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” he said in the statement. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

According to the FDA, the federal government reached agreements last summer with both Pfizer and Moderna for a total of 200 million doses in the first quarter of 2021. Because both vaccines require two doses, that agreements guaranteed enough doses for 100 million people.

Pfizer and BioNTech did not receive funding from Operation Warp Speed for vaccine research and development.