The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020.
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.
In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.
Moderna Inc.’s and Pfizer Inc.-Biontech SE’s COVID-19 bivalent boosters could be coming to the U.S. in the first week or so of September – even though the U.S. FDA just received the completed emergency use authorization (EUA) requests for the vaccines this week. The CDC is already taking pre-orders from providers, states and other jurisdictions for the yet-to-be authorized booster doses as part of its fall-winter booster campaign strategy. It also scheduled a Sept. 1-2 meeting of its Advisory Committee for Immunization Practices, signaling that it expects the FDA to grant the EUAs by the end of August.
The U.S. FDA has cleared the first clinical grade watch for characterizing atrial fibrillation (afib), the most common type of heart arrhythmia in which the heart beats too slowly or irregularly. Developed by Verily, the health tech arm of Alphabet Inc., together with IRhythm Technologies Inc., the Zio Watch will leverage the ability of IRhythm’s Zeus system to diagnose cardiac arrhythmias by combining wearable biosensing with cloud-based data analytics and artificial intelligence.
Although it’s a latecomer to the COVID-19 pandemic in the U.S., there is a wedge of opportunity for Novavax Inc.’s adjuvanted protein-based vaccine among the 10% of the U.S. adult population that has yet to get a first jab.
Now that Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19, it’s time for the CDC to weigh in. Once its Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine and make a policy recommendation, the vaccine will be available on the market.
COVID-19 is the unwanted gift that keeps on giving. The U.S. CDC unwrapped one of those “presents” in a July 12 report that showed the threat of antimicrobial-resistant (AMR) infections has worsened — with resistant hospital-onset infections and deaths in the U.S. each increasing at least 15% during the first year of the pandemic.
The COVID-19 pandemic completely rewrote the script for government responses to communicable diseases, and thus the Biden administration is wasting no time reacting to the emergence of the monkeypox virus. The administration announced June 28 that it has developed a plan to allocate the distribution of large volumes of vaccines, but the CDC has shipped tests to five major commercial lab companies, thus putting the U.S. on a strong footing to respond to the outbreak.
