Doubts loom as US gears up for vaccination

Emergency use to make residents Pfizer’s ‘clinical trial participants’

The US Food and Drug Administration (FDA) is expected to soon authorize the emergency use of Pfizer’s coronavirus vaccine, which will be another success of the US pharmaceutical giant after being given the green light in the UK and Canada. However, doubts about the safety, severity of adverse reactions and whether it has been tested on enough people loom large.

Professionals including Chinese health experts, who suspect Western countries rushed the vaccine out of political and economic needs, said more detailed clinical and basic research from a larger number of participants on safety and effectiveness is necessary. Otherwise, the emergency use in countries like the US will make its residents Pfizer’s clinical trial participants, they said.

A panel of FDA advisers voted overwhelmingly to endorse emergency use of the Pfizer/BioNTech COVID-19 vaccine on Thursday, and Reuters reported that the FDA is widely expected to authorize emergency use in days.

The authorization would kick off the largest vaccination campaign in the history of the US, which has the world’s largest number of confirmed COVID-19 patients and highest recorded death toll.

“The final decision on whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the agency said in a statement.

The FDA staff said

that the vaccine’s efficacy and safety data met its expectations for emergency use authorization, Reuters reported.

A vaccine is needed more than any time in the US as many hospitals have been running at full capacity since December, and doctors believe the post-Thanksgiving surge will lead to more widespread infections and record-setting deaths.

The mounting pressure for vaccines made some people worry whether the Pfizer/BioNTech COVID-19 vaccine has been rushed in Western countries. In a series of interviews last week, Dr. Anthony Fauci questioned British regulators for rushing through the authorization process for a coronavirus vaccine, although he later backed off and said his comments came out wrong.

Some American netizens tweeted their concerns that only several months of trials may not be enough to find out the long-term side effects.

Chinese health professionals also raised concerns that as a vaccine uses a gene-based technology known as messenger RNA that has never been approved to prevent any infectious diseases, it requires more detailed clinical and basic studies.

“The late-stage trial of Pfizer enrolled some 44,000 people, and the number should be able to work for a well-developed traditional vaccine with a reasonable statistical design, but not enough for Pfizer’s mRNA vaccine which is a completely new vaccine and the production technology is not mature,” said a Beijing-based immunologist.

More people are needed, and the exact number should be based on scientific calculations, the immunologist predicted that the total number enrolled should at least reach a million.

“The US emergency use would serve as a good clinical trial,” he said.

The clinical trials of the Pfizer/BioNTech COVID-19 vaccine excluded pregnant women, which has sparked concerns from American health experts since November.

Thursday’s FDA panel discussion chose to play down such concerns, by saying there was not enough data to support or contradict the use of the vaccine in pregnant women.

Dr. Gregory Poland, a virologist from the Mayo Clinic in Rochester, Minnesota, who previously served two terms on the FDA advisory panel, said he was surprised advisers did not voice more caution about pregnant women, Reuters reported.

Some Western media have been throwing shade at Chinese COVID-19 vaccines, claiming Chinese vaccine developers, including Sinovac, have not released efficacy data, and suspect that they may not be able to protect recipients as successfully as vaccines in the West.

In response to questions as to why China has not presented their trial data, Jiang Chunlai from Jilin University’s School of Life Sciences said that Pfizer and Moderna conducted trials in countries where the virus is rife, which helps them gather efficient data on short notice.

“There is no need to follow the Western countries in releasing data. We have our own strict reviewing criteria and will cautiously conduct rounds of reviews before releasing them to the public,” Jiang said.

As most clinical trials were conducted outside of China, China needs to transport the specimen back for testing. It takes time, analysts said.