Covid-19 roundup: Fauci says first graders could have access to vaccine by September — report; EMA begins rolling review of CureVac vaccine
NIAID director Anthony Fauci says kids as young as first grade could be eligible for Covid-19 vaccines by the time school starts in September, per Propublica.
Fauci told Propublica that age de-escalation trials are underway to prove vaccines are safe and effective in children. “I would think by the time we get to school opening, we likely will be able to get people who come into the first grade,” he said.
Pfizer and BioNTech have completed enrollment in a study with 12- to 15 year-olds, and expect to read out data early this year, a spokesperson told the news organization. Then it’ll finalize a study in 5- to 11-year-olds. Moderna, on the other hand, is still enrolling participants in its trial for kids 12 to 18 years old, and doesn’t expect data until mid-2021, the biotech said in an emailed statement to Propublica.
Johnson & Johnson, which submitted an EUA application for its one-shot vaccine last week, announced plans in October to begin testing adolescents ages 12 to 18 “as soon as possible,” Insider reported. But according to Propublica, the company has yet to begin adolescent trials.
Pfizer’s vaccine has been authorized for people 16 years and older, while Moderna’s shot was authorized for those 18 and older. Moderna announced the first patients were dosed in its Phase II/III adolescent study on Dec. 10, which is enrolling 3,000 patients in the US.
According to Moderna, effectiveness will be measured by “achieving a correlate of protection (if established) or through immunobridging to the adult population.” The kids will be given either two vaccine or placebo doses 28 days apart, and will be monitored for 12 months after the second shot. — Nicole DeFeudis
EMA begins rolling review of CureVac vaccine
The EMA has begun a rolling review of CureVac’s mRNA vaccine, the agency announced on Friday.
This means the agency’s human medicines committee has begun evaluating preliminary results from early clinical studies. The rolling review process continues until the agency has all the evidence it needs to support potential marketing authorization.
CureVac dosed the first patient in a Phase IIb/III study in mid-December, putting the company well behind an ambitious timeline that CEO Franz-Werner Haas laid out in August. Haas initially planned to kick off a pivotal Phase III by the end of 2020, and read out data that could be used to approach regulators in Q1 2021. On Dec. 21, CureVac announced it was launching a Phase III trial in healthcare workers, to run in parallel to the global Phase IIb/III trial.
Earlier this year, Bayer and CureVac entered into a “collaboration and services agreement” for the vaccine, giving Bayer responsibility for some development, supply and key territory operations.
“We are highly committed to making our capabilities and networks available to help end this pandemic,” Stefan Oelrich, president of the pharma division, said in a statement. — Nicole DeFeudis
Pfizer/BioNTech vaccine recommended for approval in Japan
Pfizer and BioNTech are lined up to get their Covid-19 shot approved for use in Japan.
A Japanese panel gave the mRNA shot the OK on Friday night, according to Reuters. The government could give its formal — and first — approval by Sunday, the news agency reported.
The country purchased 144 million doses of Pfizer/BioNTech’s vaccine, the first of which arrived on Friday, according to The Japan Times. About 400,000 doses were delivered to Narita Airport east of Tokyo, according to the paper.
The 144 million doses would have been enough to innoculate 72 million people. But after Pfizer changed its label to account for six doses per vial instead of five, Japan worries it won’t be able to stretch the supply as far. A special syringe is necessary to extract the sixth dose, which is in short supply across the country. The Japanese government put out a request earlier this week that manufacturers boost production of the syringes, the Times reported. — Nicole DeFeudis
US inks deal for 200M more vaccine doses from Pfizer, Moderna
As vaccine rollout in the US continues to lag behind schedule, President Joe Biden told reporters that his administration bought 200 million more shots — 100 million from each Pfizer/BioNTech and Moderna, which are scheduled to arrive by the end of July.
Biden made use of options built into existing contracts with the companies, according to the Washington Post. Pfizer and Moderna were already on the hook for 400 million doses to the US, and Biden said there’d be enough supply to fully vaccinate 200 million people by the end of May, the Post reported.
In a statement, Moderna said it has already committed to orders totaling 631.5 million doses, 300 million of which it promised to the US. The EU has purchased 160 million doses, and Canada 40 million. So far, over 41 million have already been supplied to the US.
“We continue to scale up our manufacturing capability, both in and outside of the United States,” CEO Stéphane Bancel said in a statement. “It is encouraging and humbling to know that more than 22 million Americans have already been protected with Moderna’s vaccine,” he added later.
Moderna says it remains on track to deliver the first 100 doses to the US in this quarter, with the next 100 million coming in May. The Cambridge, MA-based biotech set a goal to deliver the last 100 million by the end of July.
Biden said last week that his administration was taking several steps under the Defense Production Act to make sure Pfizer has all the equipment it needs to boost manufacturing.
So far, just over 46 million doses have been administered in the US, according to the CDC. And more than 68 million shots have been delivered.
Johnson & Johnson filed for emergency use authorization of its jab last week, though its shot is notably less effective than the already approved ones from Pfizer and Moderna. J&J said its shot was 66% effective at preventing symptomatic Covid-19, and 85% effective at preventing severe disease. In South Africa, where the B.1.351 has become common, the vaccine was 55% effective. — Nicole DeFeudis
Roche’s Actemra cuts risk of death in large trial — time to redeem IL-6?
The IL-6 theory is making another comeback in Covid-19.
Once marred by disappointing Phase III results on patients with early-stage Covid-19 pneumonia, Roche’s Actemra redeemed itself by cutting the risk of death in RECOVERY, the UK-based trial that’s cemented several drugs’ role as standard of care in treating coronavirus infection.
Investigators acknowledged that previous trials of Actemra, or tocilizumab, yielded mixed results and only weak evidence that it could shorten time to discharge or reduce progression to invasive mechanical ventilation or death. But they emphasized that their trial had a larger and more diverse sample size.
And the findings — gathered from 4116 hospitalized patients — were significant, they wrote in a preprint:
Overall, 596 (29%) of the 2022 patients allocated tocilizumab and 694 (33%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0.86; 95% confidence interval [CI] 0.77-0.96; p=0.007). Consistent results were seen in all pre-specified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital alive within 28 days (54% vs. 47%; rate ratio 1.23; 95% CI 1.12-1.34; p<0.0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (33% vs. 38%; risk ratio 0.85; 95% CI 0.78-0.93; p=0.0005).
With a difference in mortality of 4%, they extrapolated that for every 25 patients treated with Actemra, one additional life would be saved.
The results echo what Roche found in a smaller study where patients with Covid-associated pneumonia who took Actemra were 44% less likely to need mechanism ventilation or die down the road, compared to the placebo arm (p-value = 0.0348).
In particular, RECOVERY joint chief investigator Peter Hornby noted, all patients with low oxygen levels and significant inflammation stand to benefit.
Martin Landray, his counterpart, added that the trial results show Actemra with dexamethasone — a corticosteroid they’ve previously shown to reduce mortality — can help tackle the worst consequences of Covid-19.
“Used in combination, the impact is substantial,” he said in a statement. “This is good news for patients and good news for the health services that care for them in the UK and around the world.” — Amber Tong
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