Covid-19 roundup: Moderna has filed for vaccine use in children; Claiming leadership to combat Covid-19, US pledges to donate 500M doses of Pfizer/BioNTech vaccines through COVAX
Just days after Moderna’s vaccine was submitted for approval for use in children in the EU and Canada, the company has announced it has filed for emergency use authorization with the FDA for the administration in teens between 12 and 18.
Moderna announced in May that its Phase II/III study of the vaccine in adolescents met the primary endpoints in nearly 2,500 patients, showing an efficacy of 100% against severe symptomatic Covid-19. Because children are less likely to develop serious side effects, the trial also looked at milder cases than examined in the adult study. The study found that the vaccine was 93% effective at stopping mild cases 14 days after patients were dosed.
The company appears to be on schedule, as it previously said it planned to apply for authorization in kids in June.
Right now, Pfizer-BioNTech’s vaccine is the only one available for teens in the US. Pfizer announced this week that it will begin trials of a reduced dosage in children between the ages of 6 months and 11 years old. — Josh Sullivan
Claiming leadership to combat Covid-19, US pledges to donate 500M doses of Pfizer/BioNTech vaccines through COVAX
After being criticized for months for hoarding Covid-19 vaccines, the United States is making a grand gesture.
President Joe Biden has announced plans to buy 500 million doses of the Pfizer/BioNTech vaccine and donate them to lower-income countries in what his administration brands as a historic move to help supercharge the global fight against the pandemic.
The donation follows a separate initiative to give away 80 million excess vaccine doses already in the US stockpile for redistribution through the COVAX mechanism, coordinated by the WHO, Gavi and CEPI. That batch comprised vaccines from Moderna, Johnson & Johnson, and Pfizer/BioNTech.
The new purchase for half a billion doses will come entirely from Pfizer and, given the two-shot regimen, be enough to vaccinate 250 million people. With shipments starting in August, 200 million doses are slated to be delivered by the end of this year, while the rest will be delivered by June 2022.
While Pfizer had charged the US $19.50 per dose for domestic use, it will sell these new shots at a “not-for-profit” price, the Washington Post reported.
Following US allocation, COVAX will help deliver these shots to the 92 low- and lower-middle income countries around the world eligible for its facility, as well as the African Union.
On top of the vaccine donation, the US has contributed $2 billion to the effort and pledged to support location production of Covid-19 vaccines.
As of Tuesday, COVAX has facilitated the distribution of about 81 million shots worldwide.
“Thanks to the success of our vaccination program, the United States is beating COVID-19 here at home,” a White House fact sheet reads, with 64% of adult Americans having received at least one shot.
That success, though, has experts worried about a disconnect between the developed world and vulnerable regions for whom the pandemic is far from over, with new records in daily new cases and death tolls. Tedros Adhanom Ghebreyesus, the WHO director general, appealed to G7 just days ago to leverage their power in meeting the global target to vaccinate at least 10% of the world’s population by September, which he said would require an additional 500 million doses.
“Increasingly, we see a two-track pandemic: many countries still face an extremely dangerous situation, while some of those with the highest vaccination rates are starting to talk about ending restrictions,” he told reporters.
The doses, the White House was sure to add, will be produced at Pfizer’s facilities in Michigan, Kansas, Missouri and Massachusetts. — Amber Tong
Democrats take issue with Pfizer vaccine price
High-profile Democrats, including Sen. Elizabeth Warren (MA) and Rep. Katie Porter (CA), sent a letter to Pfizer CEO Albert Bourla on Tuesday, questioning the company’s price tag for its Covid-19 vaccine and its expected tens of billions in revenue from the vaccine.
With an eye toward future price escalations, the members of Congress note that Pfizer could end up causing private insurers to raise premiums and increase taxpayer costs for health care.
“Does the company intend to seek ‘a normal price like [it] typically get[s] for a vaccine—$150, $175 per dose.’? If so, when does the company plan to implement these increases?” they asked Bourla, in addition to questions on how much the company invested in the vaccine. The Democrats also asked how Pfizer will determine its pricing for the vaccine moving forward. — Zachary Brennan
Ocugen to no longer pursue an EUA for its vaccine
Pennsylvania-based Ocugen, which is looking to bring India’s Covid-19 vaccine from Bharat Biotech to the US, says it will no longer seek an emergency use authorization and will instead seek a full approval.
The company said FDA provided feedback on the master file it had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.
The news comes as the FDA said late last month that for the remainder of the pandemic, it may decline to review and process further EUA requests for Covid-19 vaccines, as the country still tries to administer millions of doses that it’s already purchased of the three vaccines that have already won EUAs. — Zachary Brennan
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