Novavax Started Late-Stage Trial of COVID-19 Vaccine in U.S.

By Mary Anne R. First Posted: Dec 28, 2020 10:12 PM EST

Novavax has launched the Phase 3 trial for its COVID-19 vaccine candidate in the United States, according to the drugmaker on Monday.

This was after the trial was delayed twice due to issues in increasing the manufacturing process.

The Phase 3 trial will involve up to 30,000 volunteers across the 115 sites in the United States and Mexico, according to an NBC News report.

Two-thirds of the participants will be receiving the shot 21 days apart while the rest are getting a placebo.

Novavax is behind other drugmakers in the race for COVID-19 vaccine.

Pfizer and Moderna shots have already gained an authorization of emergency use in the United States.

However, experts have said that more than one vaccine would be needed to put an end to the pandemic.

Novavax has already sealed an agreement with several countries.

The company is also set to provide 60 million doses to the UK, where a late-stage study is on its process of taking place.

The interim data from the trial is seen to be released in the first quarter of 2021.

Dr. Francis Collins, director of the National Institutes of Health said in a statement that they have come this far and quickly.

Collins added that they would need to get to the finish line.

"That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease," Collins was quoted on a CBS News report.

Novavax's Two Shot

Novavax works just like any other COVID-19 vaccines do.

The vaccine is intended to boost the body's immune response against the COVID-19 spike protein.

Novavax manufactures its own antigens by mimicking the virus' spike protein.

The drug company claimed that the said antigen can neither replicate, nor can cause COVID-19 on the patient.

The vaccine makers have shown promising results that the vaccine will be safe and effecting, with only mild reactions, which is usual of other vaccines and response against the COVID-19.

Novavax's vaccine would have one advantage over the versions currently being manufactured by Pfizer-BioNTech and Moderna.

This if it proves to be effective in its late-stage trials.

Its one advantage over other vaccines is that it would not need to be frozen.

Pfizer-BioNTech's shots need ultra-cold temperatures.

Meanwhile, Novavax's vials could be distributed across standard supply chains at refrigerator temperatures, not needing any specialized freezers.

Novavax said its Phase 3 trials have faced delays due to issues with large-scale manufacturing of its doses.

The company is relying on contractors to produce its doses, unlike pharmaceutical giants like Pfizer.

The drugmaker has also received funds from the Trump administration to trigger vaccine development.

Operation Warp Speed awarded $1.6 billion to the company over the summer.

Meanwhile, Novavax also noted that some Americans could be hesitant to receiving a placebo during the trial as compare to getting their own dose of Pfizer-BioNTech or Moderna vaccines being administered across the country.

"We wish to reassure participants that we are working to ensure that their involvement in our trial does not negatively impact their ability to be vaccinated at the appropriate time," Dr. Gregory Glenn, Novavax's president of research and development, was quoted on a report.

Novavax marks being the fifth COVID-19 vaccine candidate to enter late-stage trials before the year ends, according to a Quartz report.