FDA: Pfizer’s Covid-19 vaccine safe and effective after one dose

FDA: Pfizer’s Covid-19 vaccine safe and effective after one dose

By: Erika Edwards | NBC NEWS | December 8, 2020 – Pfizer’s Covid-19 vaccine candidate offers some protection after the first dose, with nearly full protection after the second dose, according to documents released Tuesday by the Food and Drug Administration.

The information was made public before a meeting Thursday of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC — an advisory group to the FDA that will vote on whether to advise the agency to grant emergency use authorization of the vaccine in the U.S.

The 53-page document contains analysis from both federal regulators and Pfizer on the latest data from the company’s Phase 3 clinical trial on its Covid-19 vaccine. It will be used to help guide the advisory group in its decision-making.

Based on the information provided in the document, Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group in Rochester, Minnesota, said he could “see absolutely no reason why this emergency use authorization would not be granted.” Poland is not involved in Pfizer’s vaccine trials. The Pfizer vaccine calls for two doses, three weeks apart. In November, Pfizer said early results from its Phase 3 clinical trials showed that two doses appeared to be 95 percent effective in preventing symptomatic Covid-19.

The new information shows it has benefits even after the first dose, with an effectiveness of more than 50 percent about a week later. While useful, Poland said it will be important to follow through with that second dose to “significantly boost the immune response.”

“The concern is that after a single dose, people would think ‘I’m home free.’ That would be the wrong message,” Poland said.

The vaccine’s overall effectiveness seems to be the same across all age groups, racial and ethnic minorities, and people with underlying conditions, such as obesity, diabetes and high blood pressure.

Poland called the data “a grand slam.”

“We do not have good examples of vaccines with this level of efficacy across age, gender, race and comorbidities,” he said. “I’ve never seen something like this.”

There is no evidence the vaccine caused the problem, but FDA is expected to recommend long-term follow-up of this potential issue.

Experts note it will also be important to study the vaccine’s safety and effectiveness in children, pregnant and breastfeeding women, as well as those who have compromised immune systems.

Pfizer and its German partner BioNTech expect to have 50 million doses available this year and 1.3 billion in 2021, using facilities both in the United States and Belgium.

The United Kingdom was first to roll out the Pfizer vaccine, with a 90-year-old woman near London receiving the first shot Tuesday morning.