Government Plans Three Large Phase 3 COVID-19 Vaccine Trials

The U.S. government is planning to launch phase 3 trials of three COVID-19 vaccine candidates, starting with Moderna’s as soon as next month, followed by AstraZeneca’s AZD1222 in August, and a Johnson & Johnson candidate in September.

John Mascola, director of the Vaccine Research Center of the National Institutes for Allergy and Infectious Diseases (NIAID), said the timelines are estimates and they depend on several factors, including FDA approval to proceed.

Moderna confirmed that a phase 3 trial of its vaccine candidate mRNA-1273 is expected to begin next month in collaboration with NIAID.

AstraZeneca received a contract from HHS last month that includes funding for a phase 3  trial with 30,000 participants and a separate pediatric trial (DID, May 22). The company declined to comment on the timing.

J&J said yesterday that it plans to begin phase 1/2a trials of its vaccine Ad26.COV2-S next month. The company also said that it is in talks with NIAID “with the objective to start phase 3 trials ahead of schedule.”

Meanwhile, NIAID Director Anthony Fauci is putting together a COVID-19 Prevention Network (CoVPN) to help speed the development of vaccines. The collaboration is based on the HIV Vaccine Trials Network (HVTN), which Fauci founded in 1998.

Larry Corey, NIAID adviser and one of the network’s leaders, said the network is looking to evaluate between five and seven vaccines. The effort will involve the HVTN, the Fred Hutchinson Center, the HIV Prevention Trials Network and the PTN Infectious Diseases Clinical Research Consortium at Emory University. — Jordan Williams