By Rocky Swift
TOKYO (Reuters) – Shionogi & Co is planning clinical trials by year-end for what may be one of Japan’s first domestically produced COVID-19 vaccines to reach the market, as the globe races to secure enough doses to battle the pandemic.
The company plans to put its vaccine candidate into Phase 1 clinical trials in December and shift into Phase 2 by January and apply for tentative approval from the government, Shionogi chief executive Isao Teshirogi told Reuters in an interview.
But a Phase 3 trial would likely be done overseas due to the relative lack of COVID-19 cases in Japan, he said.
Shionogi’s plan to have enough doses to inoculate 30 million people by the end of next year means its impact will be much larger than that of first mover Osaka-based AnGes Inc, which expects to have its first doses ready by March.
“For almost national security reasons, having good capacity in Japan makes a lot of sense,” Teshirogi said.
While Shionogi lags global front runners that are now conducting mass final-stage clinical trials, it is betting on a proven platform to help it become Japan’s biggest home-grown COVID-19 vaccine producer. French drugmaker Sanofi SA and Novavax are using a similar process in their COVID-19 candidate.
“I think our recombinant protein vaccine, method wise, has more accumulated data on efficacy and safety than the novel methods,” Teshirogi said.
Newer methodologies like mRNA vaccines may end up being the solution, “but as of today, we don’t know anything”, he said.
Prime Minister Yoshihide Suga has pledged to provide enough vaccine for the populace by mid-2021, and Japan has struck deals for hundreds of millions of doses with companies including AstraZeneca Plc and Pfizer Inc.
Shionogi has received about $400 million from the Japanese government for its COVID-19 vaccine research.
But the world will need several different vaccines to fight the pandemic, given the sheer size of global demand, effects on different populations, and possible limits of effectiveness in the first vaccines.
Teshirogi said holding the postponed Tokyo Summer Olympics in 2021 is “still possible”, but it will depend more on high-rapid-diagnostic testing and logistics than vaccines.
“Receiving the vaccine is not a so-called safe license,” he said.
(Reporting by Rocky Swift in Tokyo; Editing by Miyoung Kim and Michael Perry)
“This will not be a Democratic vaccine or Republican vaccine.”
Pfizer executives said in a third-quarter investor presentation on Tuesday they have not seen the first interim efficacy data yet. The Data Monitoring Committee, an independent group of experts monitoring the clinical studies and the data collection, “has not conducted any interim efficacy analyses to date,” according to Pfizer.
The slight delay from an earlier prediction of data by the end of October means results will likely not be known by Election Day, despite claims by President Donald Trump for months that a vaccine is “weeks away.”
The Data Monitoring Committee has thresholds for review that are triggered when a certain number of trial volunteers become sick with COVID-19. The first interim analysis is scheduled to happen when 32 people develop COVID-19, according to Pfizer’s extensive clinical trial protocol.
Bourla said, however, the company is still on track for a November application for authorization, if the vaccine shows to be effective and, just as importantly, safe.
Pfizer CEO Albert Bourla had previously said the company “may know whether or not our vaccine is effective by the end of October.”
Once there are 32 volunteers infected with COVID-19, Pfizer will analyze how many of them received the vaccine and how many received a placebo. If more than 76.9% of the grouping is in the placebo group, Pfizer will consider the vaccine efficacious.
Once an independent review board releases information on the trials, the company will need a week to review it internally, Bourla said.
Pfizer plans to release the interim data if it is negative (worse than 11.8%) or positive (better than 76.9%) for efficacy. If the data is somewhere in between, Pfizer will wait for more conclusive results, Bourla said.
“In case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know,” he explained to investors, adding that the company “reached the last mile here and we expect these things will start coming soon, so let’s all have patience.”
He said he is “cautiously optimistic” the vaccine will work based on earlier studies.
Pfizer said it expects efficacy and safety data will be available in November, and if it is, it will apply for emergency use authorization.
More than 42,000 participants have been enrolled and nearly 36,000 have received a second dose of the vaccine. Expanding the number of participants has allowed trials to include additional populations, among them children between 12 and 18 and people with preexisting conditions.
She began her career as a Data Processing Clerk.
In a make-shift office, now used as a closet, Cassie Mogg spent countless hours keying in numbers for the hospital’s finance department.…
Former Blue Bell Creameries CEO faces charges in connection with alleged listeria contamination coverup
A Texas grand jury charged Paul Kruse, Blue Bell Creameries’ former CEO and president, was charged with wire fraud and conspiracy in connection with an alleged cover-up of the company’s 2015 listeria outbreak, the Department of Justice announced on Wednesday.
Kruse, who served as the company’s CEO and president from 2004 to 2017, was charged with seven counts of wire fraud and conspiracy for an alleged scheme to cover up what the company knew about the listeria contamination in Blue Bell products, according to the Department of Justice.
“We firmly believe the charges will be dismissed because they are untimely,” said Chris Flood, who represents Kruse. “We look forward to a jury hearing what really happened in 2015 and Blue Bell’s response to the unfortunate events.”
Blue Bell said it would be inappropriate for the company to comment on Kruse’s legal situation since he is no longer with the company.
According to the indictment, Kruse allegedly directed employees to remove potentially contaminated products from store freezers without notifying retailers or consumers of the real reason. Kruse instructed employees to tell customers who asked about the removed items that there was an “unspecified issue with a manufacturing machine,” the indictment alleges.
Blue Bell did not issue an immediate recall of the products nor did the company inform customers about the listeria contamination, according to the indictment.
“US consumers rely on food producers and suppliers to ensure the safety of the nation’s food supply.The charges announced today show that if an individual violates food safety rules or conceals relevant information, we will seek to hold them accountable,” said Judy McMeekin, associate commissioner for regulatory affairs at the Food and Drug Administration, in a news release.”We will continue to investigate and bring to justice those who jeopardize public health.”
The ice cream was linked to 10 listeria cases in four states and resulted in three deaths in Kansas. In May, the company pleaded guilty to two misdemeanors for distributing adulterated food products and agreed to pay $19.3 million in fines for shipping contaminated ice cream during the 2015 listeria outbreak. The company shut down all its plants in 2015 cleanings and updates, according to the news release.
Listeriosis is a potentially fatal infection caused by the germ listeria, which is found in soil, water, raw milk and some animals like poultry and cattle. Unlike many other germs, it can grow in the cold temperature of a refrigerator or in a food processing plant.
– Shannon Liao contributed to this report
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.
An open letter from the frontrunner COVID-19 vaccine producer published Friday ends any expectations a vaccine might be available before Election Day.
Pfizer Inc. CEO Albert Bourla’s letter says the earliest the company could apply for authorization for its COVID-19 vaccine is the third week of November.
The CEO of the other frontrunner, Moderna’s Stéphane Bancel , said at a biotechnology conference on Sept. 30 that it would not have enough safety data to apply for Food and Drug Administration authorization of its vaccine until Nov. 25.
The other two COVID-19 vaccine candidates in final stage clinical trials in the United States, Johnson & Johnson and AstraZeneca, are both on hold as possible adverse events are investigated.
That means there is now no chance any COVID-19 vaccine could be approved before the Presidential election on Nov. 3.
The news lays to rest a concern brewing in the public health community for months that a vaccine might be rushed through to provide a political win for President Donald Trump. He has said multiple times over the past six months he anticipated a COVID-19 vaccine would be available prior to the election.
That stance shifted on Oct. 6 when the White House embraced guidelines published by the Food and Drug Administration that likely would slow approval of a coronavirus vaccine by requiring drug makers to conduct trials for two months before requesting approval.
After that shift, the only way a vaccine could have come about prior to Nov. 3 would have been if absolutely everything went right in the Pfizer vaccine trials, which are the furthest along.
The timing would have been tight. The Pfizer vaccine requires two doses given 28 days apart and it launched its U.S. Phase 3 trials on July 27. The second shots would have begun on Aug. 24. Two months of follow-up after that second shot would be Oct. 23.
Bourla’s letter makes clear it will take longer than that. Based on the company’s current trial enrollment and dosing pace, “we estimate we will reach this milestone in the third week of November,” he wrote.
The company is “operating at the speed of science,” with safety as its No. 1 priority, he said.
Even then, there will be several important safety and oversight steps after the company applies for an Emergency Use Authorization for its vaccine.
“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency,” he said.
The news is an important step in earning back the public’s trust and confidence in the vaccine evaluation and approval process, said Dr. Kelly Moore, associate director of Immunization Education, Immunization Action Coalition.
According to a poll from Informa Pharma Intelligence, a business intelligence provider, and research