Covid-19 roundup: Moderna offers vaccine to workers, contractors and board members; Claiming 79% vaccine efficacy, Sinopharm shoots for full China OK
Moderna is moving its people — workers, contractors as well as board members — to the front of the vaccine line in the US, offering them a chance to get their two shots under emergency use authorization.
The move will provide an additional layer of Covid-19 protection, the Cambridge, MA-based biotech said, as its staff is conducting essential services in developing, manufacturing and delivering a vaccine that protects against the disease caused by coronavirus.
Health authorities have been informed, according to the company, and it will shoulder all costs. It added:
The program will extend to adult household members of our team to reduce the risk of absenteeism and disruption due to a COVID-19 infection in an adult household member. Participation in the program is confidential and entirely voluntary.
Per Moderna’s most recent annual report, it has around 830 full-time employees, although the number has almost certainly gone up as it expanded its manufacturing operations. The board has eight directors, led by chairman Noubar Afeyan. It’s unclear how many contractors will be offered the vaccine.
Under Operation Warp Speed, the US has pre-ordered 200 million doses of the Moderna vaccine for the general public, enough to vaccinate 100 million people — with the elderly, healthcare and other essential workers taking priority. — Amber Tong
Pfizer says, of plans to vaccinate its employees: pic.twitter.com/c3eltz6fx4
— Meg Tirrell (@megtirrell) December 29, 2020
In a first for Chinese developers, Sinopharm says vaccine is 79.34% effective
It’s been administered to hundreds of thousands of people, and we finally have a number on how effective it is: Sinopharm says one of its inactivated vaccines showed 79.34% efficacy in an interim analysis across Phase III trials.
In a brief statement, Sinopharm said that the shot — developed by its subsidiary Beijing Biological Products Institute — didn’t break out the number of cases accrued in its trial or detail how many cases were in the vaccine arm versus placebo. What it did say was that the results reached the standards of the WHO and guidance issued by China’s drug regulators, and that it’s officially filed for marketing approval.
It also disclosed that the vaccine induced a seroconversion rate of 99.52%.
The statement marked the first public disclosure by any Chinese developer of late-stage data of their vaccines, where sporadic releases by countries and institutions have led to confusion. The United Arab Emirates, for instance, had found that the Beijing Biological Products Institute vaccine is 86% based on an interim analysis on its own data earlier this month.
Taken at face value, the 79.34% number puts Sinopharm just between vaccines developed by AstraZeneca/Oxford and the frontrunners at Pfizer/BioNTech and Moderna, which had published data suggesting 62%, 95% and 94% efficacy, respectively, for the approved regimens. But the importance of any data depends also on the study design, volunteer demographic, number of cases, criteria for defining cases and many other factors.
Along with a couple others, the vaccine has already been cleared for emergency use in state-owned enterprise employees and students traveling overseas as well as medical and aviation workers, among others. — Amber Tong
China’s Fosun to manufacture 200M doses of BioNTech vaccine
A China-based manufacturer has inked a deal to produce 200 million doses of the Pfizer-BioNTech Covid-19 vaccine.
Other details were scarce, but the Shanghai Fosun Pharmaceutical Group will establish a joint venture with Germany’s BioNTech as the world rushes to get vaccines into arms and quell the spread of the pandemic.
First reported by Caixin, the financial magazine, Fosun declined to comment on the report or the terms of the deal, and it’s unclear how long it will take to produce the 200 million doses.
The joint venture is a further expansion of the Covid-19 partnership between Fosun and BioNTech, which began back in March. Prior to Wednesday’s deal, the two groups had so far only agreed on the distribution and commercialization of vaccines manufactured in Europe.
Fosun has said previously it would buy at least 100 million doses of the vaccine for use in mainland China in 2021 if it gains regulatory approval in the country. — Conner Mitchell
Arcturus launches Phase II vaccine trial, but analysts are skeptical
As Arcturus Therapeutics charges full speed into a Phase II trial for its single-dose Covid-19 vaccine in Singapore, some analysts say weak Phase I/II data point to an uncertain path ahead.
US-based Arcturus got cleared on Monday by the Singapore Health Sciences Authority to launch a Phase II trial of its candidate, ARCT-021, developed with Duke-NUS Medical School in Singapore. The trial will enroll up to 600 participants, and determine an optimal regimen to head into Phase III, according to the company. The Phase II will evaluate both single and “prime-boost” dosing regimens.
Baird analysts, though, called the Phase I/II results “lackluster,” and wrote in a note to investors that they are “skeptical of the path for this mRNA vaccine in COVID-19.”
Arcturus’ stock $ARCT was down 54.04% on Tuesday morning, at $42.48 per share.
The reason for their concern is that ARCT-021 achieved “modest” neutralizing antibody induction across doses and ages, coming in at the lower end of the range of healthy convalescent sera. Pfizer/BioNTech’s jab, for example, achieved two- to four-fold nAb induction above healthy convalescent sera. According to Arcturus, nAb titers in convalescent sera ranged from 12 to 1818 in the Phase I/II study.
“We see little mechanistic basis by which a mRNA vaccine that achieves lesser nAb induction than peers would somehow show comparable protection from COVID-19 driven entirely by T-cell induction, given how much nAb and T-cell induction should be driven by similar means of mRNA translation/antigen presentation within transduced cells,” Baird’s Madhu Kumar and Robert Palermo wrote.
Arcturus called the Phase I/II results favorable, and said it’s planning a global Phase III launch in Q2 2021.
“The Phase 1/2 study results, together with recently generated preclinical data, indicate that ARCT-021 leads to a potent immune response to SARS-CoV-2, and demonstrates a differentiated biological profile whereby the immune response increases in the weeks following vaccination,” Eng Eong Ooi, a Duke-NUS professor and member of Arcturus’ Vaccine Platform Scientific Advisory Board, said in a statement.
Arcturus’ vaccine push is being led by Joseph Payne, who was ousted from the company over two years ago by what he called a “dysfunctional board.” Last month, he bagged a $45 million limited recourse loan from Singapore’s Economic Development Board, and inked an agreement with the country for up to $175 million in dose purchases. If the candidate is approved, Arcturus will repay Singapore’s EDB through sales royalties. If it isn’t approved, the board is willing to forgive the loan. — Nicole DeFeudis
Germany hits snags in Pfizer/BioNTech vaccine distrubution
In the rush to get jabs in arms, Germany is experiencing some distribution pains.
According to a Reuters report, some Bavarian districts are sending back 1,000 doses of Pfizer and BioNTech’s vaccine candidate following doubts they were properly refrigerated. A spokesman for the Lichtenfels district said the doses may have become too warm in their delivery cool boxes, per Reuters.
Pfizer/BioNTech’s mRNA candidate must be kept at about -70 degrees Celsius temperatures — colder than Antarctica — to remain stable. They’re being shipped in specialized boxes with dry ice, and must be kept at 2 to 8 degrees Celsius after they’re taken out of freezer storage to remain viable for up to five days.
Upon arrival in Lictenfels and other northern Bavarian districts, temperature loggers showed some interim temperatures of up to 15 degrees Celsius, Reuters reported.
“BioNTech commented and said that the vaccine was probably okay, but probably okay is not enough,” Lichtenfels District Administrator Christian Meissner told Reuters TV.
Authorities have expressed concern over Pfizer/BioNTech’s cold chain requirements, and some countries have said they can’t afford the infrastructure that would be necessary to distribute the vaccine. Moderna announced last month that their vaccine can be stored at 36 degrees to 46 degrees Fahrenheit for up to 30 days, and should be stable for 12 hours at room temperature.
Meanwhile, in the Vorpommern-Rügen district, 8 workers in an elderly care home mistakenly received five times the recommended dose of Pfizer’s vaccine, four of whom have since been hospitalized for flu-like symptoms, according to Reuters.
Pfizer and BioNTech inked a deal to double the US’ dose order last week, promising a full 200 million doses to Operation Warp Speed by July 31, 2021. — Nicole DeFeudis
Brazil VP Hamilton Mourao takes unproven Covid-19 treatment hydroxychloroquine
Months after the FDA yanked its emergency use authorization for President Donald Trump’s so-called “miracle” Covid-19 treatment hydroxychloroquine, Brazilian Vice President Hamilton Mourao is reportedly taking the unproven drug.
According to Reuters, Mourao is in “good” condition and is self-isolating at home after testing positive on Sunday.
The FDA issued an EUA for hydroxychloroquine in March, which became part of routine care for Covid-19 patients at hospitals nationwide. But by June, the NIH had stopped a larger study because interim results showed the drug didn’t improve patient outcomes. The FDA revoked its EUA, citing a lack of both benefits and risks.
“We hope this clear result will help practitioners make informed treatment decisions and researchers continue their efforts pursuing other possible safe and effective treatments for patients suffering with this disease,” James Kiley of the NIH’s National Heart, Lung, and Blood Institute said in a statement at the time.
Brazil has the third-highest amount of Covid-19 cases in the world, behind only the US and India, at 7.48 million cumulative cases. In the last 24 hours, the country has reported 18,479 new cases. — Nicole DeFeudis
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