Takeda Pharmaceutical Co. asked regulators Friday to approve the use of Moderna Inc.’s COVID-19 vaccine, which would allow it to become the third vaccine to figure in a national inoculation effort begun last month.
Takeda, which is handling domestic approval and imports of about 50 million Moderna doses, announced the filing. It has earlier said approval could be given in May.
“Takeda commits to delivering Moderna’s COVID-19 vaccine candidate in Japan as soon as possible,” Masayuki Imagawa, the head of the firm’s Japan vaccines business unit, said in a statement.
Japan kicked off its inoculations in the middle of February using Pfizer Inc.’s vaccine, the first to be approved for domestic use. But Pfizer doses, imported from European factories, are in short supply.
AstraZeneca PLC applied for Japanese approval of its COVID-19 vaccine candidate early in February, and that decision is still pending.
Takeda is also handling the approval process and domestic production of about 250 million doses of Novavax Inc.’s vaccine, which entered clinical trials in Japan late last month.
While awaiting regulatory approval, Takeda plans to start distributing the Moderna vaccine in the first half of this year, while that of Novavax is expected in late 2021.
Japan has secured rights to at least 564 million doses of COVID-19 vaccines from several overseas makers, the largest volume in Asia and more than enough for its population of 126 million.
Prime Minister Yoshihide Suga has pledged to have enough vaccine doses for the population by June before the July 23 start of the Summer Olympics in Tokyo, postponed from last year because of the virus.
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Johnson & Johnson chief executive Alex Gorsky said the company’s new partnership with Merck to produce Covid-19 vaccines could exceed a goal to produce 100 million doses by June for the U.S.
“That’s our goal,” Gorsky told the Washington Post’s David Ignatius in a live interview Wednesday morning regarding the company’s plan to accelerate production with its new partner Merck of its one-shot Janssen Covid-19 vaccine, which was granted emergency use authorization from the U.S. Food and Drug Administration over the weekend.
“Our engineers and our scientists are working hand in hand with the Merck supply chain as we speak to make this possible,” Gorsky said. “We’re very confident that… in the coming months we’ll be able to accelerate.”
Gorsky’s comments come a day after the Biden White House announced rival drug maker Merck, which has a long history of vaccine development, would collaborate with Johnson & Johnson to expand production of J & J’s Covid-19 vaccine. The Biden administration Tuesday said “the collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottlenecks facing J&J in the production of its vaccine.”
By exceeding the goal of 100 million doses of its Covid-19 vaccine by June, the Johnson & Johnson partnership with Merck would be critical to President Biden’s accelerated timeline for the U.S. to have enough Covid-19 vaccine doses for every adult American by the end of May.
Even without Merck as a partner, Johnson & Johnson has already “distributed almost 4 million vaccines,” Gorsky said.
Johnson and Johnson is committed to 20 million dosages to the U.S. by the end of March and 100 million doses by June. “This is helping to reinforce that in a significant way,” Gorsky said of the Merck partnership.
Johnson & Johnson’s Covid-19 vaccine joins vaccines made by Moderna and Pfizer that are already being given to millions of Americans and tens of millions more people around the world.
Johnson & Johnson’s vaccine only requires one dosage and can be stored in most standard refrigerators, which the company says could help reach medically-underserved areas of the U.S. and globally. Moderna’s and Pfizer’s vaccines require two shots three or four weeks apart and specialized freezers.
Though there are worries the vaccines won’t be as effective against new variants that have emerged in the United Kingdom and South Africa and have begun to spread in the U.S., Johnson & Johnson has said the vaccine will help people from getting sick and hospitalized.
Gorsky said the production of a vaccine against the Coronavirus has come a long way, dating back “13 months ago when we started on this with the genomic sequencing information.”
“When we started, some of the manufacturing facilities were literally parking lots,” Gorsky told the Washington Post Wednesday. “The complexity of bringing up this kind of scale or scope has never been done before.”
Under the partnership with Merck brokered by the Biden administration, the U.S. Department of Health and Human Services “will collaborate with Merck to repurpose some of its existing Merck facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies including the current pandemic,” HHS said Tuesday.
“The facilities will be available to private sector partners working with the federal government on the Covid-19 response or to produce Merck products against COVID-19,” HHS said in a statement. “Janssen Pharmaceuticals, part of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. Merck will use two of its facilities to produce drug substance, formulate and fill vials of J&J’s vaccine.”
Pharmaceutical companies are exploring ways to deliver vaccines without a needle by investigating new delivery methods such as patches, dissolving implants, electrical-pulse systems, nasal sprays and pills, according to a March 3 report fromThe Wall Street Journal.
The companies are exploring the possibility of needleless vaccine delivery to mitigate the challenges the current vaccine delivery system poses, such as long waits, ultracold freezing logistics and training personnel to perform needle injections. If these efforts are successful, they could create a reality in which patients can administer vaccines from their own homes, according to the Journal.
Cambridge, Mass.-based Vaxess Technologies told the Journal it is developing a combination COVID-19 and influenza vaccine patch designed so that patients can administer it yearly from their own homes. Vaxxas, also based in Cambridge, Mass., said it is developing vaccine patch technology as well.
Oxfordshire, England-based Enesi Pharma is working on a device that painlessly implants vaccines under patients' skin. Another approach is being pioneered by global health nonprofit PATH in which vaccines are freeze-dried and turned into lozenges that can dissolve under patients' tongues, according to the Journal.
Codagenix, a Farmingdale, N.Y.-based company, is developing its own single-dose COVID-19 vaccine designed to squirt up the nose. The vaccine candidate is being studied in a small, phase 1 clinical trial in London, according to the Journal.
Company will not pursue additional development of APL-9 for the treatment of severe COVID-19 Interim review by independent data monitoring committee (DMC) found no meaningful reduction in the overall mortality rate in Phase 1/2 study No safety signals were observed by the DMC.
The UK could become one of the fastest countries in the world to approve modifiedCovid vaccinesto fight variants.
Vaccine manufacturers including Pfizer and AstraZeneca are already working on new coronavirus jabs to deal with variants in case they are needed.
Once Covid-19 vaccines are adapted, the process for getting them out to the public could be fast-tracked, and the green light could be given in just a few weeks, the Medicines and Healthcare Products Regulatory Agency (MHRA) said.
She said that by carrying out a “real-time” rolling review of evidence, as was done for the existing vaccines, the MHRA’s approval would come “in a very efficient manner, as short as a couple of weeks”.
The regulatory body also said researchers can efficiently measure protectiveness by looking at antibodies in the blood after vaccines, rather than waiting for people in a trial to become infected with Covid-19.
MHRA chief executive Dr June Raine insisted no corners would be cut on safety, and the approach is similar to the regulatory process when flu vaccines are modified to deal with new strains each year.
She said: “Has this approach been done before? This approach that we’re putting out today for the Covid-19 vaccines is based on the tried and tested regulatory process which is used every year for seasonal flu jabs.”
Scientists are concerned that several variants, including the Brazilian one, could makeexisting Covid vaccinesless effective. Six cases of the Brazilian variant have been found in the UKso far - three in England and three in Scotland.
A study this week suggested 25% to 61% of people in the Brazilian city of Manaus - where the variant originated - who had previously had Covid were susceptible to reinfection.
Speaking about whether the UK would be able to get new vaccines out quicker than other countries, she said: “You will be aware that there are other major jurisdictions, the FDA (in the US) and the European Medicines Agency, and this guideline we feel is more flexible and more capable of moving in an agile way, depending on the format of the vaccine, and the data we already hold.
“You’ll be aware that the data we hold in the UK, having been agile initially, is a very substantial set of data.”
During a visit to the Glasgow Lighthouse Lab, Health Secretary Matt Hancock said: “We will have a fast-track approach to safely approving future vaccines that work against a variant of Covid-19.
“The vaccine programme has clearly been a huge UK success story, and part of the reason that we have been able to develop the vaccines so far, so quickly, is because of the MHRA’s rigorous yet flexible approach, which has been based entirely on looking as quickly as possible at the safety and efficacy of vaccines.
Covid-19 vaccine first doses in the UK as of March 2, 2021Credit: PA
“I’m delighted that they’re taking that same principled approach to the approval process for vaccines that may work against variants.”
Guidance from the Access Consortium - a group of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland - states that vaccine manufacturers will need to prove the modified jab produces an immune response, is safe and is of the expected quality.
Data from the original trials and ongoing studies on real-world use of the vaccine could be used to support any decision by the regulators. But lengthy studies would not be needed as they were deemed not to add to the understanding of the jab's safety, quality or effectiveness.
Dr Christian Schneider chief scientific officer at the MHRA, said: “Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety.
“Should any modifications to authorised Covid-19 vaccines be necessary, this regulatory approach should help to do just that.
“The announcement today also demonstrates the strength of our international partnerships with other regulators and how our global work can help ensure faster access to life-saving vaccines in the UK and around the world.
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.”
