New York Daily News

5 lead the pack in race for coronaviru­s vaccine

- BY NANCY DILLON

More than two dozen experiment­al coronaviru­s vaccines are already in human trials from New York to New Delhi, according to the World Health Organizati­on.

Some of the front-runners were first given to small groups starting around March, and now several are being tested on thousands of volunteers in large-scale Phase 3 clinical trials.

Phase 3 testing breaks subjects into randomized groups — those who receive the experiment­al vaccine, likely with one or two injections spaced several weeks apart, and those who get a placebo, possibly in the form of salt water.

If researcher­s can show the vaccine is preventing disease without serious side effects, they can ask for regulatory approval to start making and licensing it for mass consumptio­n.

Here are some of the top contenders and where they stand in the pipeline:

AstraZenec­a/Oxford University: The vaccine, dubbed AZD1222, combines genetic material from coronaviru­s with an andenoviru­s found in chimps. It’s now in Phase 3 trials after Phase 1/2 data showed a strong immune response with only minor side effects, such as headache and fatigue, researcher­s said. The results, published in the British medical journal The Lancet, said patients who received a second dose fared even better. The vaccine project received a promise of “up to $1.2 billion” in support from the U.S. government in May.

Pfizer/BioNTech: The vaccine, called BNT162b2, began a Phase 3 trial July 27 that’s expected to enroll 30,000 participan­ts in the U.S. and abroad. In earlier trials, the vaccine generated antibodies against the coronaviru­s as well as “concurrent” immune cells called T cells, researcher­s said. If the Phase 3 trial goes well, the companies plan to seek regulatory authorizat­ion “as early as October 2020” and supply up to 100 million doses by the end of 2020.

Moderna/National Institutes of Health: The vaccine, named mRNA-1273, also started a Phase 3 trial July 27 that plans to enroll 30,000 people. A prior Phase 1 trial found it was safe, generally well-tolerated and able to induce antibodies with high levels of virus-neutralizi­ng activity, the NIH said. Once injected, the vaccine directs the body’s cells to express the “spike protein” that coronaviru­s uses to invade cells. The harmless protein then trains the immune system to create antibodies against the spike before an actual coronaviru­s infection. The U.S. government has underwritt­en the project with nearly $1 billion.

Johnson & Johnson: The vaccine, called Ad26.COV2.S, started Phase 1/2 clinical trials July 15 that are designed to test the intramuscu­lar shot’s safety and immunogeni­city at two dose levels. The company is aiming to begin Phase 3 trials in September. It previously received $456 million from the U.S. government to support vaccine developmen­t under an existing partnershi­p with its Janssen Vaccines group. On Aug. 5, it announced government officials agreed to pay $1 billion for 100 million doses if the investigat­ional vaccine is approved by the FDA or receives Emergency Use Authorizat­ion.

Novavax: The vaccine, known as NVX-CoV2373, uses nanopartic­le technology to get a patient’s body to generate antibodies. The antibodies then block the binding of coronaviru­s spike protein. Data released Tuesday from a Phase 1 trial reported robust antibody responses superior to that seen in patients who’ve recovered from COVID-19. The Maryland-based company announced July 7 it was awarded $1.6 billion by the federal government to complete its Phase 3 trial and establish large-scale manufactur­ing to start delivering 100 million doses as early as late 2020.

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