Fauci ‘cautiously optimistic’ about safe, effective COVID-19 vaccine by end of year

COVID-19 took center stage at the virtual CHEST Annual Meeting, with a keynote by Anthony S. Fauci, MD.

“We are now in the middle of an explosive pandemic of historic proportions, the likes of which we have not experienced in the last 102 years, with over 1 million deaths worldwide and 38 million cases — and the end is not in sight,” Fauci, director of the National Institute of Allergy and Infectious Diseases, told virtual attendees. “Unfortunately, for the United States, we are the worst-hit country in the world with 7.7 million cases and over 214,000 deaths.”

With rising cases worldwide, research on the SARS-CoV2 virus, potential treatments and vaccines continues at a rapid pace.

“Given the rate of infection that is going on in this country and the distribution of the clinical trial sites involving tens of thousands of volunteers, we project that we will have an answer as to whether or not we have a safe and effective vaccine by November or December of this year,” Fauci said.

He cautioned: “There’s never a guarantee for a vaccine, but we are cautiously optimistic that we will have a vaccine that would be safe and effective by the end of this year, and we’ll be able to distribute doses at the end of this year and throughout the beginning and middle of 2021.”

Fauci said the NIH has developed a strategic approach to COVID-19 vaccine research and development, with unprecedented collaboration and resources to develop safe and effective vaccines for COVID-19 that can be manufactured and delivered in the scale of billions of doses to people around the world. Three platforms are currently in development: nucleic acid, which is messenger RNA; viral vectors, such as human adenovirus, chimp adenovirus and vesicular stomatitis virus (VSV); and the more standard protein subunits, he said. Five vaccine candidates are currently in phase 3 trials.

“Based on the data that we’ve seen from animal studies and data from the phase 1 trial that indicated that the vaccine induces a robust neutralizing antibody response equivalent to, if not greater than, natural infection, we are cautiously optimistic,” Fauci said.

During a panel discussion after the keynote, Ryan Maves, MD, FCCP, chair of the American College of Chest Physicians COVID-19 Task Force and critical care and infectious disease specialist at the Naval Medical Center San Diego, said “the odds are very high” for data supporting a vaccine by the end of 2020 and rollout in 2021.

One of the key prioritizations following availability of a safe and effective vaccine is determining who gets it first. Maves said it will be essential to get it to populations at the greatest risk, such as those who are Black, Latinx and Asian Americans.

“We need to make sure we reach out to those folks, both in building trust in those communities that they will benefit from a safe and effective vaccine and making sure we get it to them as quick as possible,” Maves said.

During the keynote, Fauci highlighted a “disturbing racial and ethnic disparity” involving individuals who are Black, Latinx, Native American, Alaskan Native and Pacific Islander, with an increase in the incidence of COVID-19 and serious complications that can lead to more severe outcomes.

Other populations at higher risk for COVID-19 and severe outcomes include older adults, those of any age with underlying medical conditions such as cardiovascular disease, diabetes, obesity or overweight, cancer, COPD, chronic kidney disease, asthma, cystic fibrosis, hypertension, pulmonary fibrosis, those with an immunocompromised state from solid organ transplant and those with neurologic conditions, among others.

A number of therapeutic options are under investigation to treat patients with COVID-19 infection, including direct antivirals, convalescent plasma, hyperimmune globulin, monoclonal antibodies and immunomodulators.

The two treatments that have been strongly recommended by the NIH treatment guideline panel are remdesivir, which is used in hospitalized individuals who require oxygen for lung involvement, and dexamethasone, which is used in advanced hospitalized patients requiring mechanical ventilation or requiring oxygen.

There are also evolving data on the use of monoclonal antibodies, Fauci said, in which clinical trials are being conducted on an outpatient basis, an inpatient basis, family prophylaxis and broad primary prophylaxis in nursing homes.

The NIH maintains a “living document” of the most recent data, with recommendations on how to care for and treat individuals with COVID-19 population, he said. The recommendations can be found at: COVID19treatmentguidelines.nih.gov.

Message for those on the front lines

Speaking to the virtual CHEST Annual Meeting attendees, Fauci said the members of the CHEST community have demonstrated how to be a global leader during the COVID-19 pandemic and public health emergency.

“I want to extend my deep gratitude to the CHEST community for your tireless dedication to patient care during this unprecedented COVID-19 pandemic. At great risk to your own health, your teams have been at the forefront of the COVID-19 response offering expert care and compassion to patients who are not only sick, but also separated from their loved ones,” Fauci said. “Additionally, as a medical society, your members have collaborated to produce and share valuable resources that health care professions everywhere can use to increase their clinical knowledge base and raise their level of care.”

‘More tools in our toolbox’

Currently, COVID-19 cases are rising in most parts of the United States. During the panel discussion, Mangala Narasimhan, DO, FCCP, senior vice president and director of critical care services at Northwell Health System in Long Island, New York, described a “mini surge” occurring in her region.

“What we saw the first time around was very different. We had over 900 patients intubated at our health system in March and April. Now, 30 patients [are] intubated,” she said. Now, “we have a lot more tools in our toolbox. ... We are much more optimistic about this mini surge.”

Narasimhan described the experience at the start of the pandemic, compared with today, from opening new ICUs every 24 hours to issues with the supply chain and personal protective equipment (PPE) to no paralytics and limits on sedation and antibiotics.

At the start of the pandemic, “we didn’t really know what we were doing to treat these patients. We really were guessing and discussing, trying to come up with treatment plans on our own as a division,” Narasimhan said. Now, “we have a lot more information, a lot more trials have been published, the supply chain is much more intact, we have ventilators now that are not in short supply. And, I think what we have learned is that we don’t have to be afraid of the virus when we are well protected — if PPE works and if people are wearing their protection, things are OK.”