Why Pfizer and BioNTech are seeking full approval of their Covid-19 vaccine, Novavax says it will apply for authorization of its Covid-19 vaccine in the third quarter of this year, and more.
- Pfizer and BioNTech have requested FDA provide their Covid-19 vaccine with full approval, rather than its current emergency use authorization (EUA), for people ages 16 and older. A full approval would allow the two companies to market the vaccine directly to consumers—and, according to Politico, make it easier for schools, businesses, and the military to require vaccinations. The companies requested priority review, meaning they asked FDA to issue a decision within six months rather than the standard 10 months. As part of the process, the companies will submit data on a rolling basis over the coming weeks on its manufacturing sites and practices, in addition to all of its pre-clinical and clinical trial data, Becker's Hospital Review reports (Morello/Owermohle, Politico, 5/7; Adams, Becker's Hospital Review, 5/7; Bowman, NPR, 5/7; Johnson, Washington Post, 5/5; Anthes, New York Times, 5/7; Castronuovo, The Hill, 5/6).
- CDC last week issued a report warning of "repeatedly documented" cases of the new coronavirus spreading through the air to people more than six feet away—findings that according to The Hill demonstrate CDC's shifting emphasis on the coronavirus being spread via airborne transmission. "Transmission of [the new coronavirus] from inhalation of virus in the air farther than six feet from an infectious source can occur," the document said, though it noted this occurrence is "less likely than at closer distances." CDC in the document said the highest risk of this type of transmission occurs indoors in places with "inadequate ventilation," when people are either exposed for a long period of time, or are shouting or singing. Previously, CDC's guidance had said most infections were acquired via "close contact, not airborne transmission" (Sullivan, The Hill, 5/7; Hassan et. al., Washington Post, 5/7; Rabin/Anthes, New York Times, 5/7).
- Novavax on Monday said an early study of its combination Covid-19 and influenza vaccine in ferrets found the shot produced a "robust" antibody response to both the coronavirus and influenza A and B. Although the shot is still in the early stages of development, Novavax said clinical trials in humans "are expected to begin by the end of the year." Relatedly, Novavax said it intends to apply for an EUA from FDA for its Covid-19 vaccine in the third quarter of this year, and that safety and effectiveness data on its vaccine should be released as soon as this month (Sullivan, The Hill, 5/10; Coleman, The Hill, 5/10; Weintraub, USA Today, 5/11; Loftus, Wall Street Journal, 5/10; Johnson, Washington Post, 5/10).
- CDC and HHS have launched a service that will allow people to find Covid-19 vaccines near them through text message. The service is being launched alongside vaccines.gov, a website that allows people to search for available Covid-19 vaccine doses by ZIP code, as well as a 1-800 number for those who wish to get vaccine information by phone. In addition, David Kessler, chief science officer for the White House's Covid-19 response team, told senators on Tuesday that Americans will not have to pay for potential booster shots because the government has funding to acquire the shots (Jercich, Healthcare IT News, 5/3; Weixel, The Hill, 5/11; Kopp, Roll Call, 5/11).
- CDC on Wednesday announced it has identified 28 people who developed blood clots with low platelets after receiving the Covid-19 vaccine developed by Johnson & Johnson (J&J), an increase from the 17 previously reported cases. The 28 cases—including four people who as of May 7 were still in the hospital—were discovered after more than 8.7 million doses of the vaccine were administered, CDC said. According to the agency, all 28 cases occurred before CDC and FDA paused use of the vaccine on April 13. CDC also said the risk of dying from Covid-19 is 40 times higher than the risk of dying from the blood clots associated with J&J's vaccine (LaVito/Griffin, Bloomberg, 5/12; Weixel, The Hill, 5/12; Miller, Reuters/NBC News, 5/12; Kopecki/Mendez, CNBC, 5/12; McPhillips/Fox, CNN, 5/12; Roubein, Politico, 5/11).
- HHS on Monday announced the launch of the Covid-19 Coverage Assistance Fund, an effort to ensure providers are fully reimbursed for the cost of administering Covid-19 vaccines to patients whose health plans either don't cover vaccination fees or require patient cost-sharing. Through the fund, HHS' Health Resources and Services Administration will reimburse providers at national Medicare rates. In addition, CMS announced that, effective May 6, it will increase the Medicare rate for administering monoclonal antibodies used to treat Covid-19 in most health care settings from $310 to $450. The rate will be $750 for monoclonal antibodies administered in a patient's home (Morse, Healthcare Finance News, 5/3; Brady, Modern Healthcare, 5/4; Paavola, Becker's Hospital CFO Report, 5/6; Brady, Modern Healthcare, 5/6).