January 29, 2021

Novavax, J&J just released vaccine trial results. Here's what you need to know.

Daily Briefing

    Johnson & Johnson (J&J) and Novavax separately released preliminary clinical trial data on their Covid-19 vaccine candidates, setting the stage for the companies to seek FDA's authorization for the experimental vaccines. Here's what the data shows—and what it could mean for America's coronavirus epidemic, according to experts.

    Related: The U.S. Covid-19 vaccination scenario planning guide

    What the data says on J&J's vaccine

    During a press conference held Friday with NIH, which helped conduct J&J's Covid-19 vaccine trial, J&J released a preliminary analysis of its Phase 3 clinical trial data for its Covid-19 vaccine candidate. J&J's vaccine candidate is different than the two Covid-19 vaccines currently authorized for use in the United States—which are manufactured by Pfizer and BioNTech, as well as Moderna—because J&J's vaccine requires patients to receive just a single dose, rather than two. In addition, J&J's vaccine uses an adenovirus instead of messenger RNA to trigger an immune response to combat the novel coronavirus.

    To test the vaccine candidate's effectiveness and safety, J&J and NIH launched a clinical trial with a "diverse and broad" patient population, the company said. Researchers enrolled in the trial 44,325 participants from across the world, including 44% of participants from the United States, 41% from Central and South America, and 15% from South Africa. Among the trial's participants, 59% were white, 45% Hispanic or Latinx, 13% were Black, 6% were Asian, and 1% were Native American. Some of the participants had underlying health conditions, including HIV, hypertension, Type 2 diabetes, and/or obesity.

    According to the preliminary analysis, J&J's vaccine candidate was 66% effective at preventing both moderate and severe Covid-19 cases 28 days after trial participants received their vaccinations. When looking only at severe cases of Covid-19, the vaccine was 85%, the analysis found.

    In addition, the analysis showed J&J's vaccine candidate prevented hospitalizations or deaths related to Covid-19. According to the analysis, no deaths related to Covid-19 occurred among participants who received the experimental vaccine, but five deaths linked to Covid-19 occurred among patients who received a placebo.

    Paul Stoffels, J&J's chief scientific officer, said the preliminary analysis showed the vaccine candidate appeared to have a strong efficacy among participants regardless of their age.

    However, the preliminary analysis showed that the vaccine candidate's efficacy varied based on geography. For instance, the analysis found the vaccine was 72% effective among clinical trial participants in the United States, but it was 66% effective among participants in Latin America. Further, the analysis showed that the vaccine candidate was just 57% effective in South Africa, where a new variant of the novel coronavirus, called B.1.351, has been circulating. Research suggests that variant is more transmissible than the original version of the novel coronavirus and more resistant to vaccines and treatments for Covid-19. On Thursday, U.S. officials announced the first known cases of the B.1.351 variant in the United States.

    In terms of safety, the preliminary analysis showed fevers occurred in 9% of participants who received the vaccine candidate, and fevers of more than 104 degrees occurred in 0.2% of participants who received the experimental inoculation. The analysis also that showed one participant had a stroke during the trial, which led researchers to the pause the trial earlier this year. However, scientists ultimately determined that the stroke was not related to the experimental vaccine, Stoffels said. Overall, the analysis showed that serious adverse events were less common among those who received the experimental vaccine than among those who received the placebo.

    J&J in early February expects to request an emergency use authorization (EUA) for its vaccine candidate from FDA. If the FDA grants the EUA, the company will be prepared to immediately ship out doses of the vaccine, though J&J did not offer details on how many doses would be available, STAT News reports.

    According to the New York Times, federal officials familiar with J&J's production of the experimental vaccine has said the company might have seven million doses ready to ship immediately if it receives an EUA and about 30 million doses available by early April.

    What the data says on Novavax's vaccine

    Separately, Novavax on Thursday released preliminary data from its Phase 3 clinical trial for its Covid-19 vaccine candidate, which requires patients to receive two doses and uses recombinant nanoparticle technology to activate an immune response against the novel coronavirus. For the trial, Novavax enrolled 15,000 participants from the United Kingdom between the ages of 18 and 84. According to Novavax, 27% of the participants were older than 65.

    Novavax said the preliminary data showed its experimental vaccine was 95.6% effective at preventing Covid-19 caused by the original version of the novel coronavirus and 85.6% effective at preventing Covid-19 caused by a more-transmissible variant first identified in the United Kingdom, called B.1.1.7, which has now been detected in more than 40 countries, including the United States. According to Novavax, the preliminary data showed 62 cases of Covid-19 occurred in the trial, with 56 of those cases occurring among participants who received a placebo and six among participants who received the vaccine candidate.

    In addition, Novavax said preliminary data from a separate Phase IIB clinical trial being conducted in South Africa showed its vaccine candidate was 49.4% effective at preventing Covid-19 caused by the B.1.351 variant.

    Novavax said it is developing booster shots for its vaccine candidate aimed at offering better protection against the new coronavirus variants, and it plans to begin testing those shots in people during the second quarter of 2021.

    Currently, Novavax executives said they're in talks with U.S. regulators to determine whether the data the company's gathered so far from its U.K. and South Africa trials is adequate for the company to apply for an EUA from FDA. According to Politico, Novavax also is continuing to enroll participants in a U.S.-based trial on the vaccine candidate.

    What the data means for America's coronavirus epidemic

    The data comes as U.S. officials are looking to speed up America's slower-than-expected rollout of Covid-19 vaccines. CDC data shows that, as of Thursday morning, the federal government had distributed about 48.4 million doses of the United States' two authorized Covid-19 vaccines, which each require that patients receive two doses of the inoculations a few weeks apart. According to CDC's data, a total of about 26.2 million doses of the vaccines had been administered to Americans as of Thursday morning. Of those, about 21.7 million Americans had received "one or more doses," and about 4.3 million had received two doses, the data shows.

    According to STAT News, the preliminary data from both J&J and Novavax shows their vaccine candidates each have efficacy levels above the 50% threshold originally established by FDA for receiving an EUA from the agency, but their efficacy levels are lower than the 90% or higher efficacy levels seen with America's currently authorized Covid-19 vaccines. As a result, some observers felt the data on J&J's and Novavax's experimental vaccines was disappointing.

    For example, Eric Topol, director and founder of the Scripps Research Translational Institute, called J&J's clinical trial results "disappointing," but he also noted that the vaccine prevents hospitalizations and deaths from Covid-19, which is valuable. J&J’s results also "reinforce[e] how lucky we were that the first two [authorized Covid-19 vaccines in the United States] were more effective," he said.

    But other observers and stakeholders noted that J&J's one-shot vaccine presents an advantage, in that it can ensure people are vaccinated against Covid-19 more quickly. For instance, Stoffels told STAT News that "[i]n a pandemic, if you can, with a single-dose vaccine, very quickly eliminate the severe consequences of death, hospitalization, and severe disease, that's what's important for society."

    Akiko Iwasaki, a virologist at Yale University, said it's difficult to compare the trial results from the United States' two authorized vaccines with this new data on J&J's vaccine candidate, because those trials also took mild Covid-19 cases into consideration, while J&J's trial only accounted for moderate to severe Covid-19 cases.

    Still, Iwasaki called the data on both J&J's and Novavax's vaccine candidates strong. Further, Iwasaki said it's important that as many people get vaccinated as possible, because of persistently high numbers of new coronavirus cases and the lack of immunity among the population.

    "We've got to get [a] dose to as many people as possible," Iwasaki said. "These variants that are more transmissible and potentially even more lethal are on the rise. I think time is really what we're fighting against" (Herper, STAT News, 1/29; Zimmer et al., New York Times, 1/29; Johnson/Achenbach, Washington Post, 1/28; Lim, Politico, 1/28; Hensley/Palca, NPR, 1/28; Novavax release, 1/28; New York Times, 1/29; "The COVID Tracking Project," The Atlantic, accessed 1/29; CDC data, updated 1/28).

     

    Advisory Board's take

    Ourtake: 4 takeaways on the Johnson & Johnson, Novavax vaccine trial results

    By Brandi Greenberg, Vice President, Life Sciences and Ecosystem Research Pam Divack, Senior Analyst

    Johnson & Johnson and Novavax's promising data provides hope that we may soon have more effective vaccines to deploy against the Covid-19 pandemic. Although this early data shows the Novavax and Johnson & Johnson's vaccines may be less effective overall than Pfizer and Moderna's vaccines, they can still play a crucial role in combatting the Covid-19 pandemic.

    Notably, Johnson & Johnson's vaccine, which was shown to be 85% effective in protecting against severe disease in a single shot, may be able to quickly reduce hospitalizations and severe cases of Covid-19, potentially restoring health system capacity at scale and reducing the death toll from the pandemic because it doesn't require people to come back for a second dose like the current vaccines on the market. In addition, Johnson & Johnson's vaccine does not require complex cold-chain transportation and storage and can stay viable in a refrigerator for three months. This is much easier to transport across the country (and world) than the current mRNA vaccines, and it can conceivably help governments and public health leaders offer vaccines in more rural/isolated areas, or in areas with fewer cold-storage capacities.

    As we await the final data and FDA emergency review, there are four things we will keep watching:

    1. To effectively utilize vaccines with different efficacy rates, regulators, governments, and health systems might need to develop and implement policies for vaccine allocation based on population risk level. For example, if Johnson & Johnson's vaccine is 66% effective overall, the federal government could recommend prioritizing it for younger, healthier populations, while reserving the Moderna and Pfizer vaccines with 90%+ efficacy for more high-risk populations.

      Regulators may also need to allocate vaccines according to where new Covid-19 variants are most prevalent, especially if the likely-to-be-authorized vaccines are less effective than current options against the new strains. For example, since the Novavax vaccine was shown to be 49.4% effective against the South African variant of the novel coronavirus, leaders may want to allocate the Novavax vaccine to areas where the South Africa variant is less prevalent. While such complex policy decisions are not immediately imminent, the new data underscores the need for better genomic surveillance in the United States, as we may need to allocate vaccines according to where the new variants are most prevalent.


    2. Vaccine manufacturers are investing in developing booster shots and testing new variations of their existing vaccines to effectively target the new Covid-19 strains; such efforts may impact efficacy levels and vaccine strength in the future. For example, Johnson & Johnson is testing whether two doses of their vaccine can offer additional protection. If that proves to be the case, it's likely that anyone who received the single dose option will be eligible for that "boost." Novavax is also looking to develop a booster shot for the new strains; they expect to start clinical testing in the second quarter of this year. Both mRNA vaccine manufacturers are also actively looking at both modifications and booster options. As a result, improvements to the existing vaccines may add to our confidence and use of the vaccines in the future.

    3. The US government may face a crossroads over whether to purchase more doses of Johnson & Johnson and Novavax's vaccines, which may be less effective than mRNA options, or bet on other manufactures’ ability to increase production. Currently, the United States has pre-purchase agreements for 100 million doses of Johnson & Johnson's vaccine and 100 million doses of Novavax's vaccine. Given President Biden's recent announcement that the United States will have enough doses to vaccinate 300 million Americans by end of summer and commitment to purchase an additional 100 million doses from Pfizer and Moderna, it remains unclear whether the United States will also invest in buying more doses from Johnson & Johnson and Novavax, if those vaccines are granted emergency use authorizations.

    4. Health care leaders must continuously address vaccine skepticism and mistrust—and be prepared to address tough questions about the distribution and allocation of potentially less effective shots and perceived inequities. While Covid-19 vaccine hesitancy has declined in recent weeks, according to recent KFF polling data the general public will undoubtably have questions about the new vaccines, how they work, and how they are different from Pfizer's and Moderna's mRNA vaccines. More importantly, they will have questions and concerns about how vaccines are allocated—for example, why some populations might get Johnson & Johnson's shot, versus Pfizer's or Moderna's.

      Some people may even try to "shop" for certain vaccines and delay vaccination or try to seek multiple vaccinations. Health care leaders must be prepared to answer these questions and explain the benefits of each vaccine. They must also
      be vigilant in watching for signs of perceived or actual distribution inequities. For example, if more affluent, urban and suburban populations are better able to access to the mRNA vaccine because they have multiple vaccine options, but marginalized or rural communities have access to just one vaccine, that could worsen inequities and issues of mistrust in the medical field.

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