A draft of the joint statement, which is still being finalized by companies such as Pfizer Inc., Johnson & Johnson and Moderna Inc. and reviewed by The Wall Street Journal, commits to making the safety and well-being of vaccinated people a priority. of the companies. Vaccine manufacturers would also commit to adhere to high scientific and ethical standards in conducting clinical studies and in manufacturing processes.
The companies could issue the pledge as soon as next week, according to two people familiar with the matter. The statement would join a growing number of public assurances from industry executives that they are not taking shortcuts in their rapid testing and manufacturing of the vaccines.
“We believe this commitment will help ensure public confidence in Covid-19 vaccines that can ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated,” says the draft statement.
Many Americans are skeptical or reluctant to take a Covid-19 vaccine, largely as a result of concerns that the development of the vaccine, or potential clearances, is accelerating. Vaccine development typically takes years, yet Covid-19 injections are progressing at a rapid pace as companies and countries rush to stop the spread of the coronavirus.
Now, driven by concerns about whether such a regulatory decision could come before regulators fully examine a vaccine, scientists and industry executives are making unusual public assurances about a commitment that their products will work as expected. safe way.
The companies’ draft statement says drug manufacturers will submit government emergency use authorization or license applications for vaccines based on “substantial evidence of safety and efficacy” from phase 3 clinical trials conducted under the guidance of the Food and Drug Administration. Phase 3 studies, which are the final stages of testing, are designed to show whether injections can reduce rates of symptomatic Covid-19 disease compared to people without vaccination.
Several vaccines are in (or will soon begin) large clinical trials of at least 30,000 people, with the potential for interim results in the coming months and possible emergency use authorization or full approval. Last week, the Centers for Disease Control and Prevention, which is expected to be involved in the distribution of vaccines, notified the US states that they should be ready to launch vaccination campaigns against Covid-19 in November. . An FDA meeting of outside experts to discuss Covid-19 vaccines is also scheduled for late October.
That schedule, just before the November 3 presidential election, raised concerns among some scientists and other experts that the Trump administration would rush a vaccine to bolster President Trump’s re-election prospects. The US government has committed to delivering 300 million doses by January 2021 and is preparing for distribution.
The FDA has said that it will not green light a Covid-19 vaccine unless it is shown to be 50% effective compared to a placebo.
The FDA’s decision on a vaccine in the coming weeks would come on the heels of controversy over two high-profile emergency use authorizations.
Its recent authorization of convalescent plasma to treat Covid-19 patients faced accusations of politicization and criticism for not being based on a placebo-controlled study. The emergency use authorization of hydroxychloroquine, a Trump-touted antimalarial, which was rescinded over safety and efficacy concerns, also drew criticism.
Pfizer CEO Albert Bourla said the company expects to have enough data in October to request an emergency use authorization if the study results are positive. For the Pfizer and Moderna vaccines, subjects must return several weeks later for a second dose, leaving only a few weeks of evaluation for even the first enrolled subjects for an upcoming regulatory submission.
Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia, which sits on the FDA’s vaccine advisory committee, said in an interview Thursday that it seemed unlikely that there would be enough data to demonstrate the efficacy of Covid vaccines. -19 at the end -Testing stage at the end of October. I was hoping that wouldn’t happen before the beginning of next year.
In recent days, government officials have tempered expectations about the timing of a vaccine.
Moncef Slaoui, a senior adviser to the White House’s Covid-19 vaccine development program, told Science magazine this week that he would resign if Trump officials push for an emergency use authorization that he does not endorse. Slaoui, a former GlaxoSmithKline PLC executive, said on National Public Radio on Thursday that trial data was unlikely to be ready by October.
Drug companies and executives have issued statements and spoken in forums designed to bolster confidence in the vaccine development process in recent days.
“We all understand the need to act urgently given the pandemic, but we will not sacrifice safety under any circumstances,” Merck & Co. CEO Ken Frazier said Thursday at an event organized by the International Federation of Product Manufacturers. Pharmaceuticals and Associations, a trade group. Merck said in July that it planned to begin the first human study for one of its experimental vaccines in late September, and a second to begin testing later this year.
At the same forum, Mr. Bourla, CEO of Pfizer, said the company would never submit any vaccine for authorization or approval before “we consider it to be safe and effective.” He also said that Pfizer has not felt any political pressure to rush a vaccine. “We will not take shortcuts,” Bourla said.
The Biotechnology Innovation Organization, another trade group, also released an open letter to industry on Thursday that sets out principles for developing Covid-19 vaccines and treatments, and evaluating the release of data from ongoing clinical trials.
The letter also says: “Republicans and Democrats must put aside political considerations.”
Write Peter Loftus at [email protected] and Jared S. Hopkins at [email protected]
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