Covid-19 roundup: FDA seeks vaccine adcomm meetings on Dec. 8-10 — report; Hahn to make all EUA data public
With Pfizer releasing its completed Phase III efficacy and safety data Wednesday morning, the FDA is reportedly asking its adcomm to set aside dates in early December to discuss Covid-19 vaccines.
The adcomm will likely convene on Dec. 8, 9 and 10 to go over not only Pfizer’s vaccine candidate, but also Moderna’s, according to a CNBC report. The plans are not yet finalized, per two sources quoted in the story.
Pfizer said in a press release Wednesday morning that the company and its partner BioNTech have reached the number of confirmed Covid-19 cases to complete its late-stage trial. Initial data show the vaccine 95% effective at preventing Covid-19, and 94.5% effective in older adults.
The pair have also crossed the FDA’s key safety threshold of two-months follow-up and will submit for an emergency use authorization “within days,” they said.
Moderna, which like Pfizer is using mRNA technology to develop its vaccine, announced Monday the interim results from its Phase III study, saying their candidate was 94.5% effective. The company is also expected to release final data soon and submit its own EUA shortly thereafter. — Max Gelman
Amid pressure, FDA promises to make all data for EUAs public
In an effort to shore up public confidence, FDA chief Stephen Hahn said in a statement Tuesday that the agency will be making public all data and information related to emergency use authorizations for Covid-19 vaccines and drugs.
The move comes after polls have shown growing worry among Americans that politics has been put before science and that early vaccines may not see full adoption due to concerns they’ve been rushed. In order to counteract this, Hahn said regulators have already taken several steps, including hosting a vaccine adcomm and creating educational materials to explain the steps of the drug and vaccine development processes.
Tuesday’s move just marks another step in reassuring the public, Hahn said.
“Let me be clear on a crucial point — the issuance of an EUA is based on data and science,” Hahn said. “For an EUA to be authorized, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product.”
Hahn added that should new data come about, the agency can adapt or revoke an EUA, which it has done previously during the pandemic.
Leading up to this month’s election, public health officials had faced pressure from President Donald Trump, who made getting a vaccine out before November as one of his key campaign promises. That didn’t happen, however, with Pfizer and Moderna both releasing the first efficacy data for their Phase III vaccine studies after the election was called for Joe Biden.
The Trump administration has taken other steps to pressure the FDA, with HHS Secretary Alex Azar openly plotting Hahn’s ouster at one point, and bristled after Hahn toughened vaccine requirements in late September. Pfizer had originally aimed for just 32 confirmed cases in its first analysis, prompting CEO Albert Bourla to say the company would know if it worked by October. But after speaking with regulators, they bumped that up to 62. Ultimately, they registered 94 cases. — Max Gelman
Study says Sinovac vaccine induces quick immune response, but lower antibody count
Chinese biotech Sinovac published peer-reviewed results for its Covid-19 vaccine candidate CoronaVac on Wednesday, with data showing the vaccine triggered a quick immune response in patients.
But the same data also illustrated that the level of antibodies produced was lower than in those who had recovered from the disease. The results, coming from Sinovac’s Phase I/II trial enrolling more than 700 individuals, were published in full in The Lancet.
“In summary, CoronaVac was well tolerated and induced humoral responses against SARS-CoV-2, which supported the approval of emergency use of CoronaVac in China and in three phase 3 studies,” the authors of the paper wrote. “The protective efficacy of CoronaVac remains to be determined.”
Wednesday’s paper comes after the company released topline Phase I/II results in June, which said the vaccine safely produced antibodies in more than 90% of volunteers. The vaccine has been described as old school, using a chemically inactivated virus in the hopes of creating a protective antibody response.
Sinovac is one of two Chinese companies, along with Sinopharm, testing a Covid-19 vaccine in Phase III studies. Currently, Sinovac is conducting multiple Phase III trials in Brazil, Indonesia and Turkey, and its vaccine was one of the candidates authorized by the Chinese government in July to be administered to some medical professionals and border officers.
Last week, Brazil halted its Phase III Sinovac trial after the death of a trial participant, but the hold was lifted after it was determined the individual died by suicide.
Sinovac is currently 5th in Endpoints News’ Covid-19 vaccine race tracker. — Max Gelman
For a look at all Endpoints News coronavirus stories, check out our special news channel.