Breakthroughs Blog: CDC

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. On Thursday, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off on a recommendation from a CDC advisory panel endorsing Pfizer-BioNTech COVID-19 booster shots for millions of older or otherwise at-risk Americans, following an emergency use authorization from the US Food and Drug Administration the previous day. Dr. Walensky expanded on the advisory panel’s recommendations—which supported the use of boosters in people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying conditions—to also include those ages 18 to 64 who are health care workers or live in institutional settings that put them at increased risk for COVID-19 exposure. Boosters will begin rollout among individuals at least six months past their last dose of the Pfizer-BioNTech vaccine.The World Health Organization (WHO) updated its COVID-19 therapeutics guidelines Friday to include a recommendation for use of Regeneron’s antibody cocktail among non-severe patients at higher risk for hospitalization. The antibody treatment, a combination of casirivimab and imdevimab, is currently recommended in the United States for use in patients with mild-to-moderate COVID-19 cases to prevent a need for hospitalization, but WHO will now work to expand its use to low- and middle-income countries where access has been more difficult due to its high cost and limited availability. WHO and Unitaid are working with manufacturers to ensure equitable distribution around the world, as well as potential donation and distribution of the drug through UNICEF.A COVID-19 vaccine candidate developed by Clover Biopharmaceuticals showed 67 percent efficacy against illness in a global phase 2/3 clinical trial, the company announced last week. The vaccine demonstrated 84 percent efficacy against moderate-to-severe COVID-19 and 100 percent efficacy against severe COVID-19 and hospitalization. The results also varied among variants of the virus, with efficacy at 79 percent against the delta variant and 59 percent against the mu variant. Clover plans to use the data to seek conditional approval later this year in China and the European Union, as well as emergency use listing from WHO, which would clear the vaccine for use by the COVAX vaccine-sharing facility, to which Clover has agreed to provide up to 414 million doses. The shot is stable under normal refrigeration conditions for at least six months, making it well-suited for global distribution.

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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, an advisory committee to the US Centers for Disease Control and Prevention (CDC) recommended that Pfizer’s COVID-19 vaccine be offered to adolescents between the ages of 12 and 15, following the vaccine’s authorization for this age group by the US Food and Drug Administration earlier in the week. CDC Director Rochelle Walensky adopted the recommendation later Wednesday, clearing the way for vaccine clinics to begin to vaccinate 12-to-15-year-olds. The recommendation was based on data indicating the vaccine was protective for this age group; in a trial of 2,260 adolescents, there were 18 confirmed cases of COVID-19 among those who received a placebo and no confirmed cases among those who received the vaccine.A newly established COVAX Supply Chain and Manufacturing Task Force will seek to jump-start global vaccine manufacturing capacity with a three-stage plan to enhance existing production capacity, as well as develop a new vaccine manufacturing group to bolster production in the long term. The plan seeks to address immediate manufacturing bottlenecks by identifying and matching “fill and finish” manufacturers with producers of active ingredient, accelerating approvals of export permits and customs clearances, and facilitating partnerships for the supply of vital vaccine inputs. The longer-term goals will include developing a manufacturing workforce to maximize more production using existing systems and expanding production capacity in low- and middle-income countries.Adults over 50 who received mixed types of COVID-19 vaccines for their first and second doses were more likely to report mild and moderate side effects, according to early results from a trial in the United Kingdom. The trial is evaluating whether mixing doses of the AstraZeneca and Pfizer vaccines might provide longer-lasting immunity or better protection against new variants. The findings showed more reports of chills, fatigue, headache, joint pain, malaise, and muscle aches among participants who received two different vaccines than those receiving two doses of the same vaccine, but no other safety issues were identified. Further data, including on whether and how the immune response is affected, could be released in the coming months as the studies continue.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.Moderna is studying a new version of its COVID-19 vaccine that could be kept refrigerated for up to three months, according to a statement released Thursday. Currently, the vaccine can be stored at refrigerator temperatures for one month after being thawed from its frozen storage temperature, which requires ultra cold-chain equipment that is not widely available globally. If authorized, the refrigerator-stable vaccine could increase the number of locations able to vaccinate using Moderna’s shot. The company also announced plans to invest in manufacturing facilities in Switzerland, Spain, and the United States, which would boost its capacity to produce up to 3 billion doses of the mRNA-based vaccine in 2022.The ANTICOV clinical trial has begun recruitment for a new arm of its study that will test a combination of nitazoxanide and ciclesonide to treat patients with mild-to-moderate COVID-19 infection. ANTICOV, coordinated by the Drugs for Neglected Diseases initiative, is the largest trial in Africa seeking to identify early COVID-19 treatments to prevent progression to severe disease and potentially limit transmission. The study began in September with an adaptive platform design, allowing treatments to be added or removed as new evidence emerges. Nitazoxanide, an antiparasitic, and ciclesonide, an inhaled corticosteroid, are both already commercially available, and if shown to be effective against COVID-19, the treatment combination could be affordable and easy to access and administer.Adults in the United States over the age of 65 who have been fully vaccinated with either the Pfizer/BioNTech or Moderna COVID-19 vaccine are 94 percent less likely to be hospitalized with the disease than those not vaccinated, according to new data released by the US Centers for Disease Control and Prevention (CDC) on Wednesday. The findings also showed partial vaccination reduced the risk of hospitalization by 64 percent. Based on hospitalization data from two surveillance networks originally established to monitor serious influenza disease, the new evidence represents a real-world evaluation of the two mRNA-based vaccines in the United States. CDC says it is planning additional ongoing efforts to measure COVID-19 vaccine effectiveness to inform future vaccine policy.