Anthony Fauci, director of the NIAID, says children from the first grade may be eligible for Covid-19 vaccines by the time school starts in September, Republic.
Fauci told Propublica that age decalcification trials are underway to prove that vaccines are safe and effective in children. “I would think that by the time we reach school opening, we will be able to get people coming in first grade,” he said.
Pfizer and BioNTech have completed a study with 12- to 15-year-olds and expect to read data early this year, a spokesman for the news organization said. Then it will complete a study in 5- to 11-year-olds. Moderna, on the other hand, is still enrolling participants for their trial for children aged 12 to 18, and does not expect data until mid-2021, the biotechnology said in an email to Propublica.
Johnson & Johnson, which last week filed an EUA application for its one-shot vaccine, announced plans in October to test teens ages 12 to 18 as soon as possible. Insider report. According to Propublica, the company has not yet begun adolescent trials.
Pfizer’s vaccine is approved for people 16 years and older, while Moderna’s shot is approved for 18 and older. Moderna announced that the first patients were admitted on December 10 in the Phase II / III adolescent study, which enrolls 3,000 patients in the US.
According to Moderna, the effectiveness will be measured by “achieving a correlate of protection (if established) or by means of immuno-expenditure on the adult population.” The children receive two doses of vaccine or placebo 28 days apart, and they will be monitored 12 months after the second shot. – Nicole DeFeudis
EMA launches ongoing review of CureVac vaccine
The EMA has begun an ongoing review of CureVac’s mRNA vaccine, the agency announced Friday.
Franz-Werner HaasThis means that the agency’s human medicine committee has started evaluating the preliminary results of early clinical studies. The ongoing review process continues until the agency has all the evidence needed to support potential marketing authorization.
CureVac dosed the first patient in mid-December in a Phase IIb / III study, which put the company well behind an ambitious timeline set out by CEO Franz-Werner Haas in August. Haas initially planned to kick off a crucial Phase III by the end of 2020 and read out data that could be used to approach regulators in the first quarter of 2021. On December 21, CureVac announced that they were launching a Phase III trial among health workers, to be conducted in parallel with the global Phase IIb / III trial.
Earlier this year, Bayer and CureVac entered into a ‘collaboration and service agreement’ for the vaccine, which gave Bayer responsibility for development, supply and key area operations.
“We are very committed to making our capabilities and networks available to end this pandemic,” said Stefan Oelrich, president of the pharmaceutical division, in a statement. – Nicole DeFeudis
Pfizer / BioNTech vaccine recommended for approval in Japan
Pfizer and BioNTech are queuing up to get their Covid-19 shot approved for use in Japan.
According to a Japanese panel, the mRNA according to OK gave the OK on Friday night Reuters. The government can give its formal – and first – approval by Sunday, the news agency reports.
The country purchased 144 million doses of Pfizer / BioNTech vaccine, the first of which arrived on Friday, according to The Japan Times. About 400,000 doses were delivered at the Narita airport east of Tokyo, according to the newspaper.
The 144 million doses would have been enough to innocent 72 million people. After Pfizer changed its label to offset six doses per vial instead of five, Japan is worried that it will not be able to stretch the stock that far. A special syringe is needed to withdraw the sixth dose, which is rare nationwide. The Japanese government earlier this week called on manufacturers to increase production of the syringes, the Times reported. – Nicole DeFeudis
US ink gets 200 million more vaccine doses from Pfizer, Moderna
With the explosion of vaccines in the US still lagging behind, President Joe Biden has told reporters that his government has bought another 200 million shots – 100 million from each Pfizer / BioNTech and Moderna, which is expected to arrive by the end of July.
According to Biden, Biden used options built into existing contracts with the companies Washington Post. Pfizer and Moderna already had 400 million doses in the US, and Biden said there was enough stock to fully vaccinate 200 million people by the end of May, the Post reported.
In a statement, Moderna said it had already committed to placing orders for a total of 631.5 million doses, of which 300 million were promised to the US. The EU bought 160 million doses, and Canada 40 million. So far, more than 41 million have been supplied to the US.
Stéphane Bancel“We continue to improve our manufacturing capabilities, both inside and outside the United States,” CEO Stéphane Bancel said in a statement. “It is encouraging and humble to know that more than 22 million Americans have already been protected with Moderna’s vaccine,” he later added.
Moderna says it remains on track to deliver the first 100 doses to the U.S. this quarter, with the next 100 million in May. The biotech-based biotechnology from Cambridge, MA, aims to deliver the last 100 million by the end of July.
Biden said last week that its administration under the Defense Production Act is taking several steps to make sure Pfizer has all the equipment needed to promote manufacturing.
To date, just over 46 million doses have been administered in the US, according to the CDC. And more than 68 million shots were fired.
Johnson & Johnson applied for emergency permission for its push last week, though its shot is less effective than the approved Pfizer and Moderna devices. J&J said his shot was 66% effective in preventing symptomatic Covid-19, and 85% effective in preventing serious illnesses. In South Africa, where the B.1.351 became common, the vaccine was 55% effective. – Nicole DeFeudis
Roche’s Actemra reduces the risk of death in a major trial – time to release IL-6?
The IL-6 theory makes another comeback in Covid-19.
Once the disappointing Phase III results on patients with early Covid-19 pneumonia were affected, Roche’s Actemra redeemed itself by reducing the risk of death in RECOVERY, the trial in the UK that the role of various drugs as standard for the treatment of coronavirus infection confirmed. .
Investigators acknowledged that previous tests of Actemra, or tocilizumab, had yielded mixed results and only weak evidence that it could shorten the time to download or reduce the progress towards invasive mechanical ventilation or death. But they stressed that their experiment is bigger and more diverse.
And the findings – collected from 4116 patients admitted to the hospital – were significant, they write in a pre-print:
Overall, 596 (29%) of the 2022 patients assigned to tocilizumab and 694 (33%) of the 2094 patients assigned to regular care die 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 assigned to tocilizumab were likely to be discharged alive from the hospital within 28 days (54% vs. 47%; rate ratio 1.23; 95% AI 1.12–1.34; p <0.0001). Among those who did not receive invasive mechanical ventilation at baseline, patients receiving tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (33% vs. 38%; risk ratio 0.85; 95%); KI 0.78-0.93; p = 0.0005).
With a mortality rate difference of 4%, they revealed that for every 25 patients treated with Actemra, one more life would be saved.
The results reflect what Roche found in a smaller study where patients with Covid-associated pneumonia taking Actemra were 44% less likely to have ventilation mechanism or die in the street compared to the placebo arm ( p-value = 0.0348).
Peter Hornby, co-principal investigator for the recovery, noted in particular that all patients with low oxygen levels and significant inflammation benefit.
Martin Landray, his counterpart, added that the trial results show that Actemra with dexamethasone – a corticosteroid they were shown earlier to reduce mortality – could help tackle the worst effects of Covid-19.
“When used in combination, the impact is significant,” he said in a statement. “This is good news for patients and good news for the healthcare services that care for them in the UK and around the world.” – Amber Tong
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