Attempting to ride booster adcomm coattails, Moderna says its Covid-19 shot is better than Pfizer/BioNTech
As the FDA prepares to convene an adcomm to discuss Pfizer/BioNTech’s Covid-19 vaccine boosters later this week, the other major mRNA player is sticking its thumb out and trying to hitch a ride on the corporate media blitz.
Moderna put out a press release Wednesday afternoon pointing to two recently unveiled studies that, the biotech asserts, solidify the need for Covid-19 boosters, leaping into the ongoing debate for the shots. The release comes merely hours after briefing documents for the Pfizer/BioNTech adcomm went public, with Moderna putting forth an argument for why its vaccines are better suited to combat the Delta variant than Pfizer and BioNTech’s jab.
In particular, Moderna highlighted an interim CDC estimate released last week looking at vaccine effectiveness between June and August, when Delta was the predominant virus strain in the US. This analysis concluded that Moderna vaccine recipients were less likely to be hospitalized than those who received either the Pfizer/BioNTech or J&J shot.
“Across all ages, [vaccine effectiveness] was significantly higher among Moderna vaccine recipients (95%) than among Pfizer-BioNTech (80%) or Janssen (60%) vaccine recipients,” the analysis said.
The biotech also drew attention to a preprint of a real-world study looking at more than 350,000 people who had received two Moderna doses through the end of June. Compared to the same number of unvaccinated individuals, Moderna saw a vaccine efficacy of 87% against Covid-19 diagnosis and 96% against hospitalization.
Though these data had been public for at least a week — the CDC data came out on Sept. 10 and the preprint is dated Sept. 2 — Wednesday marked the first time Moderna stressed the importance of the analyses. The biotech published the release less than two weeks after holding a press briefing in which it laid out some yet-to-be peer-reviewed data likely to be included in booster shot submissions.
The earlier meeting largely outlined Moderna’s plan for booster shots in immunocompromised individuals, such as those receiving dialysis. Wednesday’s release, however, dealt more with vaccine effectiveness in the general population.
In addition to the two outside studies, Moderna tacked on a new analysis coming from the open-label extension of its original Phase III vaccine study. This analysis looked at breakthrough infections in study participants between July 1 and Aug. 27, with Moderna evaluating both vaccine recipients and those who initially received the placebo but were administered the shot after the biotech received an EUA.
At 13 months of follow-up in the active trial arm, researchers observed 162 breakthrough Covid-19 cases, compared to 88 after eight months in the crossover group. With a 36% reduction in incidence rates between the groups, the biotech concluded that individuals vaccinated more recently were less likely to contract Covid-19.
“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a statement. “We hope these findings are helpful as health authorities and regulators continue to assess strategies for ending this pandemic.”
Moderna published a preprint of the breakthrough study on Wednesday afternoon at the same time as the press release.
The booster debate has taken over the biopharma world in recent weeks as the Delta variant continues to surge in the US. President Joe Biden’s administration had aimed to begin delivering boosters to the general public as early as next week, though the timing of the shots has reportedly changed from eight months post-second dose to six months.
That announcement, however, sparked concerns over political meddling in FDA affairs. In response to the White House leapfrogging the agency on a booster announcement, two senior vaccine officials submitted their resignation in protest at the end of August. Earlier this week, the officials — Marion Gruber and Phil Krause — co-authored a paper with the WHO in the Lancet arguing booster shots are unnecessary.
Pfizer and the FDA will make their cases at the booster shot adcomm on Friday. Moderna submitted its initial booster plan to regulators earlier this month, roughly a week after wrapping its BLA for full approval of the original two-dose regimen. Pfizer and BioNTech received full approval for their Covid-19 vaccine on Aug. 23.