Covid-19 roundup: Albert Bourla says Pfizer PhIII is at 23,000 patients, submission coming end of October
Months ago, public health officials thought it could take several months to prove a vaccine works. Even when continually high coronavirus case counts in the US made trials easier to run, there was still concern about how quickly companies would be able to enroll volunteers.
On Thursday, though, Pfizer CEO Albert Bourla disclosed that, as of yesterday, Pfizer had reached 23,000 volunteers in the Phase III trial for their mRNA Covid-19 vaccine, a “significant number” of whom have already gotten the second dose. That would put Pfizer and their partner BioNTech just 7,000 patients short of their target and, Bourla said, in line to give an update on efficacy by the end of October.
“By the end of October… we should have enough events to know if the product works or not,” Bourla said, adding they would “immediately” submit for the vaccine approval. “We’ve already worked on the rest of the file,” he said.
The timeline would be in line with what government officials are evidently preparing for. The CDC this week sent out a letter to states urging them to prepare for vaccine distribution by October 1. Those plans appeared designed for either a vaccine from Moderna or Pfizer. These candidates, both composed of mRNA, have to be kept in ultra-cold storage settings, making the distribution more complex than for other vaccines.
Moderna, the other company with a Phase III vaccine trial that has kept apace with Pfizer, was at 17,458 enrollees as of last Friday.
Bourla also said that the company had developed an antiviral molecule that is now in the clinic and would have safety results before the end of the month. Pfizer has said for months that it is working on antivirals, but it had not disclosed a compound. A clinical trial listing for the drug, known as PF-07304814, went up earlier this week. It is a 56-person Phase I study.
“It could be an alternative for people who don’t respond very well to remdesivir,” Bourla said, “or it could be in combination.”
– Jason Mast
US says it won’t pay remaining WHO dues
Following the announcement that the US plans to leave the WHO in July, government officials said Wednesday the country would not pay its remaining dues to the organization.
The US is expected to withdraw on July 6, 2021, and has remaining dues of about $80 million that are owed. That money will instead be redirected toward funding other United Nations programs, according to a Reuters report. About $18 million remains from the country’s obligations from fiscal year 2019, while the remaining $62 million is from fiscal year 2020.
Most of the money will help pay for children’s immunization and flu programs, and the US will continue to support WHO work in Libya and Syria and on eradicating polio in Pakistan and Afghanistan, the New York Times wrote. American officials working as advisors to the WHO will also be withdrawn.
UN members are required to give one year’s notice about withdrawals. About two months ago, on July 7, President Donald Trump formally notified the WHO that the US would be leaving and claimed that it had become a mouthpiece for China during the Covid-19 pandemic.
Historically, the US has been the biggest booster of the WHO, helping found the organization after World War II. Joe Biden, the Democratic presidential nominee, has said he will re-enter the WHO should he win the November election. — Max Gelman
CDC director tells states to be ready for vaccine distribution by Nov. 1
Drugmakers aren’t the only ones facing pressure to hurry out a vaccine. Last week, CDC director Robert Redfield penned a letter to state governors, requesting that vaccine distribution sites be fully operational by Nov. 1.
Redfield urged governors to fast-track permits and licenses, according to a McClatchy report. “The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” the letter read.
“CDC urgently requests your assistance in expediting applications for these distribution facilities … and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,” it continued.
The Aug. 27 request came on the same day that president Donald Trump gave a national speech promising a “safe and effective” vaccine within the next four months. And rumors have spread that members of the Trump administration told Democratic leader Nancy Pelosi a vaccine candidate could get emergency approval as early as September, and that it would likely be AstraZeneca’s.
Distributors are bracing for significant challenges ahead, including the availability of cold storage facilities to keep vaccines stable. Some mRNA candidates must be stored at temperatures as low as -80 degrees Celsius.
Moderna, which expects to complete Phase III enrollment for its vaccine trial this month, said its candidate would need to be stored long-term at -20 degrees Celsius. BioNTech and Pfizer’s candidate requires long-term storage at -70 degrees Celsius. Last week, the companies announced they’ve enrolled nearly half of 30,000 expected Phase III participants.
FDA commissioner Stephen Hahn has vowed vaccine approval will be strictly data-driven. “We at FDA do not permit politics to enter into our scientific decisions,” he tweeted last week.
We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA‘s 18,000 career employees, I want to reassure the American public about this commitment.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
But the commissioner is facing heat for misleading comments he made about the efficacy of convalescent plasma as a Covid-19 treatment. Days later, he announced that a vaccine advisory committee meeting will take place on Oct 22.
“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said in an interview with KHN on Tuesday. “I’m not concerned about political pressure.” — Nicole DeFeudis
Steroids reduce mortality by 20% in severe Covid-19 cases, researchers say
A new analysis of seven international trials is pointing toward steroids as a potentially effective treatment for the sickest of Covid-19 patients.
The study, published in JAMA on Wednesday, pooled data from trials utilizing three types of corticosteroids in more than 1,700 patients in intensive care. Researchers found that the risk of death was reduced by 20% and asserted that the drugs should be the first-line treatment for severely ill patients.
“The meta-analysis indicates that administration of steroids is clearly associated with benefit among critically ill patients with COVID-19, although the exact threshold at which an individual patient should be prescribed corticosteroids remains unclear,” researchers wrote in a related editorial.
Late Wednesday, the WHO updated its treatment guidance to make a “strong recommendation” for the use of low dose hydrocortisone, dexamethasone and methylprednisolone in critical cases. The paper did not find that the drugs had any effect on milder Covid-19 patients.
Only Gilead’s remdesivir has proven to be effective in treating severe Covid-19 cases, though its benefits thus far have been limited.
Wednesday’s paper follows studies from Oxford researchers back in June indicating that dexamethasone could reduce the risk of mortality in such cases. The steroid had shown by itself a one-third reduction among patients on ventilators and a one-fifth reduction in those receiving oxygen.
Steroids can cause some side effects such as opening the body to other infections, however, and the WHO’s new guidance said that those risks reinforce that the drugs should not be used in milder cases. — Max Gelman
China expands emergency vaccine use to aviation industry
First it’s the military. Then came offers for state employees dispatched overseas, as well as medical workers and border control officers. Now, China is handing out experimental coronavirus vaccines to those in the aviation industry.
The move is an expansion of the emergency use program that began in July, whose stated goal is to boost the immunity of high-risk groups to prevent a new wave of infections.
China’s aviation regulator has told airlines, airports, China National Aviation Fuel Group and TravelSky Technology that their frontline workers can access a vaccine candidate on a voluntary basis, Reuters reported citing a notice.
It’s unclear which vaccines the workers will be given. Previous reports of vaccination campaigns at state-owned enterprises also triggered ethical concerns about consent, as experts believe employees may feel pressured to say yes to a vaccine despite lack of safety and efficacy data from large-scale trials.
Four vaccine candidates from Chinese developers have entered Phase III — all overseas — so far. Among them, CanSino’s adenovirus-based shot is authorized for military use while Sinovac and Sinopharm both have vaccines cleared for administration among high-risk groups. — Amber Tong
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