Pfizer seeking full-fledged FDA approval…
Pfizer and its partner in developing its COVID-19 vaccine, BioNTech, announced early Friday (May 7) that they are seeking full FDA approval in people ages 16 and older.
The vaccine was the first to get the go ahead from the FDA on Dec. 11, 2020, but that was a provisional emergency use authorization.
“Pfizer executives have said that the emergency-use authorization limits what they can do to raise awareness about the benefits of the vaccine and instill confidence in its safety and effectiveness, amid hesitancy by many Americans,” the Wall Street Journal reported.
The press release from the companies says they will submit data on a rolling basis and that the PDUFA date for an FDA will be set once that the Biologics License Application for the vaccine is finished and formally accepted by the FDA.
…and an EUA for young teens
The New York Times reported on Monday (May3) that the FDA is getting to approve an emergency use authorization for the Pfizer vaccine in adolescents, ages 12-15.
The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet this coming Wednesday (May 12) starting at 11 a.m. The safety, immunogenicity and efficacy of the Pfizer vaccine in 12- 15-year-olds is the top item on the agenda.
Lower antibody levels among vaccinated transplant recipients
It remains an open question how much protection people with compromised immune systems get from the COVID-19 vaccines. Research findings reported in JAMA on Wednesday (May 5)showed that among solid organ (kidney, liver, heart, lung, pancreas, multiorgan) transplant recipients, just 15% of the 658 participants in a study of transplant recipients had a measureable antibody response 21 days after the first dose of the vaccine. That increased to 57% after the second dose but that means a sizable minority don’t have an antibody response.
“Although no threshold has been established for protective immunity, antibody levels were well below that which has been observed in immunocompetent vaccines,” wrote Brian J. Boyarsky, M.D., Ph.D., and his Johns Hopkins colleagues, although as they acknowledge antibody levels aren’t necessarily the full story when it comes to immunity because memory B cell and T cells may also be a factor.
A second wave of vaccines may be on its way
CureVac, a small German biotech company, may announce results from late-stage results this week, the New York Times reported on Wednesday (May 5). Novavax, a company based in Gaithersburg, Maryland, is ramping up for emergency use application in the next couple of weeks, according to the newspaper.
Other companies working on vaccines that might be part of this second wave include Sanofi and GlaxoSmithKline, who are cooperating on vaccine that has had some setbacks but could enter the approval process later this year, and Valneva, a French company.
Biden administration backs patent waivers; industry objects
On Wednesday (May 5), the first day of two-day meeting of the World Trade Organization, U.S. Trade Representative Katherine Tai announced the administration’s support of a patent waiver for the COVID-19. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” said her prepared statement.
Global public health experts and several governments (India, South Africa) say the patent waivers would ramp up the global supply of the vaccines and are critical to curbing the pandemic is medium- and low-income countries.
Not so, say vaccine makers and some governments (notably Germany), who see the waivers as undercutting private industry’s response to the pandemic and the successful efforts at developing safe and effective vaccines quickly. PhRMA and its CEO, Stephen Ubel, issued a statement on Wednesday that said “this decision [by the Biden administration] will sow confusion between public and private partners,…