Global Pharmaceutical Companies: "No Government Approval for COVID-19 Vaccines Until Safety Certification"

The photo shows the 'Sputnik V' vaccine developed and officially registered by Russia. (Photo by Yonhap News)

[Asia Economy Reporter Seungjin Lee] Global pharmaceutical companies developing vaccines for the novel coronavirus infection (COVID-19) are reportedly preparing a joint pledge stating that they will not seek government approval until the safety and efficacy of the vaccines are proven, according to the U.S. Wall Street Journal (WSJ) on the 4th (local time).

WSJ reported that it is unusual for pharmaceutical companies to pursue such a pledge to alleviate concerns over the vaccine development race, stating that companies including Pfizer, Johnson & Johnson, and Moderna are preparing a joint declaration containing this pledge.

In the pledge, these pharmaceutical companies commit to prioritizing safety and the health of vaccinated individuals, and to applying high scientific and ethical standards in clinical trials and manufacturing processes of the vaccines. WSJ cited multiple sources saying the pledge is expected to be disclosed as early as next week.

This report comes amid concerns that U.S. President Donald Trump is pushing vaccine development too hastily ahead of the November presidential election. At a White House press conference on the 4th, President Trump said, "We expect a COVID-19 vaccine to be available within this year," adding, "It could come before November 1st, possibly in October."

The Centers for Disease Control and Prevention (CDC), responsible for distributing the COVID-19 vaccine, also announced last week that vaccination could be possible by November. An external expert meeting on COVID-19 vaccines hosted by the FDA is scheduled for late October.

Some have raised concerns that the government might be rushing vaccine administration before the November 3rd election day to support President Trump's re-election bid. Generally, vaccine development takes several years.

Earlier, Russia's 'Sputnik V,' the world's first registered COVID-19 vaccine, raised safety concerns by skipping the usual Phase 3 clinical trials and registering for use first, deviating from standard vaccine development procedures.

The draft pledge that companies are preparing includes a provision that emergency approval from the government should only be requested after sufficient verification of safety and efficacy in Phase 3 clinical trials of COVID-19 vaccines, conducted according to FDA guidelines.

In the final stage of vaccine development, Phase 3 clinical trials, it must be proven that the symptom manifestation rate in the vaccinated group is lower compared to the unvaccinated group. Currently, clinical trials for several vaccines involving at least 30,000 participants are underway or about to begin.

These vaccines are expected to produce preliminary results within the next few months and may receive emergency use authorization or approval from the government.

This content was produced with the assistance of AI translation services.