Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, shared his thoughts on existing and emerging measures to control the coronavirus disease 2019 (COVID-19) pandemic in a discussion with the New York Press Club.1

Currently, 2 COVID-19 vaccines are available for immunization in the United States: Pfizer-BioNTech and Moderna COVID-19 vaccine, which were approved by an emergency use authorization (EUA) in 2020. Both are mRNA vaccinations, shown to have 95.0% and 94.1% efficacy, respectively, in the prevention of COVID-19 infection.2,3

Other vaccine candidates have shown promising findings, and are expected to be approved in the United States in the coming months. Johnson and Johnson (J&J)’s COVID-19 vaccine candidate, Ad.26.COV2.S, a single-shot option, was found to provide 72% protection against moderate and severe COVID-19 at 28 days postvaccination in the United States (66% protection worldwide), and was 85% effective in preventing severe/critical COVID-19 globally.2

Novavax’s candidate, NVX-CoV2373 was reportedly 95.6% effective against the original SARS-CoV-2 strain in a phase 3 study conducted in the United Kingdom, and 85.6% effective against the variant that originated in the UK.3


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Are the new vaccine candidates effective?

“At first glance [72% efficacy with Ad.26.COV2.S] may not seem as good as 94% or 95%, but the important part is that for advanced, severe disease it was quite effective,” Dr Fauci said, noting that there were no hospitalizations or deaths among participants who received the J&J vaccine.

Dr Fauci stated that the J&J vaccine will be important in the United States, but it is particularly crucial to developing nations. The single-dose nature of the vaccine, its comparatively low price, and lack of a need to be stored at ultra-low temperatures may make distribution more feasible globally, according to Dr Fauci.

“I believe by March or April, we likely will get [US-based clinical trial] results [of the Novavax vaccine], and if it is as successful in the United States as it was in the United Kingdom, that would give us 4 candidates. The science of how we are addressing this outbreak is really very, very positive,” Dr Fauci said.

Are mRNA-based vaccines the way of the future?

“I believe as many of my colleagues do that looking ahead in the future, this platform technology will be used in a number of different diseases: I’m sure HIV – we are working on that already – malaria, tuberculosis, and even some cancer vaccines will likely utilize the mRNA technology,” Dr Fauci said in response to this question submitted by the Clinical Advisor.

The mRNA technology has exceeded Dr Fauci’s expectations; he admitted that when clinical trials began, he did not anticipate that there would eventually be 2 highly effective mRNA COVID-19 vaccines available by the end of 2020.

What impact do variants have on the efficacy of vaccines?

Dr Fauci noted that currently available data suggest the efficacy of the J&J and Novavax candidates is diminished by mutant strains of SARS-CoV-2; however, they were still effective in preventing severe COVID-19 regardless of the strain. Dr Fauci discussed strategies to minimize the spread of the mutant strains that originated in the UK (B.1.1.7) and South Africa (B.1.351).

“Those kinds of mutations are something that you have to be concerned about and pay attention to. We are making already . . .  versions of the current vaccines that have been upgraded to be able to be directed specifically against some of the mutants, particularly the [variant] in South Africa, which is the most troublesome one,” Dr Fauci said. Pfizer-BioNTech and Moderna are working on developing booster shots to protect against the emerging, highly contagious variants.

How can we best distribute currently available vaccines?

Getting shots into arms across the US is the “highest priority” for President Biden and Vice President Harris, according to Dr Fauci. He pointed out that the Defense Production Act could be invoked to speed up distribution; for example, this legislation could spark the rapid production of needles that allow clinicians to extract 6 doses out of vials of the Pfizer vaccine instead of 5. It could also be used to help open up community vaccine centers, assist pharmacies in becoming fully engaged in distribution, and establish mobile units to distribute doses to remote communities. At press time, President Biden has invoked the Defense Production Act.

When asked if it is ill-advised to administer as many first doses of the vaccines to people without reserving a dedicated supply of second doses, Dr Fauci explained that this hinges on the speed of distribution.

“If you have confidence … that the flow of predictive numbers of vaccines that are going to come your way will in fact come on time, you can do that. You would not necessarily need to hold back for the second shot,” he said.

Are COVID-19 vaccines safe for pregnant women?

While pregnant women were not included in clinical trials, Dr Fauci noted that more than 10,000 pregnant women have received COVID-19 vaccines since they became available.

“There have been no red flags of safety concern thus far,” he said.

Why is vaccine confidence lower in communities of color?

Dr Fauci noted that vaccine hesitancy in Black patients stems from a history of institutional racism in medicine. He cited “shameful” incidents like the Tuskegee Study as reasons why communities of color may be hesitant to accept a new vaccine.

“The first thing you have got to do is … to respect the fact that their hesitancy is based historically on things that were done and perpetrated on brown and Black people,” he said.

Dr Fauci stressed that safeguards have been put in place to ensure that unethical experiments stay in the past. However, he recognizes that the short timeline in which COVID-19 vaccines were developed could lead to accusations of scientists cutting corners and being careless.

“The answer is no, that getting things done in months as opposed to years is purely a reflection of the extraordinary and spectacular scientific advances in vaccine platform technology, which has allowed us — without compromising safety and without scientific integrity — to get things done really quickly.”

When can we expect a return to normal?

“I can’t give a definitive date, but I can give some hints on what I believe will happen,” Dr Fauci said. “I have spoken many times about how we would need about 70% to 85% of the population to be vaccinated before we have what we call herd immunity.”

Dr Fauci believes that “some degree of normality” could be achieved through herd immunity as early as the fall of 2021, but he stressed that this is not a guarantee.

“There still may be enough [community] infection that you may not want to have theaters or entertainment venues open, but I think there is a reasonable chance that if we can get that percentage of people vaccinated, that we will be able to go to a movie or a theater [in the fall of 2021].”

References

1. New York Press Club Speaker Series featuring Dr Anthony Fauci. Presented at: New York Press Club broadcast; January 29, 2020. https://www.nypressclub.org/watch-the-video-dr-fauci-speaks-with-the-ny-press-clubs-steve-scott/

2. Johnson & Johnson announces single-shot Janssen COVID-19 vaccine candidate met primary endpoints in interim analysis of its phase 3 ENSEMBLE trial [press release]. Johnson & Johnson; January 29, 2021. Accessed February 5, 2021. https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial

3. Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK phase 3 trial [press release]. Novavax, Inc; January 28, 2021. Accessed February 5, 2021. https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3