Writing in the Journal of the American Medical Association (JAMA) on August 7, Dr. Stephen Hahn, director of the U.S. Food and Drug Administration, said the FDA would not take shortcuts before it was approved for market. In an opinion piece entitled “Strong Regulatory Safeguards for New Crown Vaccines” published by Dr. Hahn et al., the United States will bring in independent experts to review the new crown candidate vaccineand and to ensure its safety and effectiveness in accordance with existing medical product regulatory standards.
“The government’s emphasis on the pace of vaccine development has fueled public anxiety about the safety and efficacy of vaccines.” Dr. Hahn et al. wrote. The article stressed that despite the unprecedented u.S. government launch of Operation Warp Speed, which has invested heavily in supporting accelerated vaccine development, the FDA must conduct rigorous regulatory reviews independently of the government. The U.S. government’s financial support for Moderna alone is now close to $1 billion.
The FDA issued a guidance document on the development and licensing of new crown vaccines on June 30. The paper recommends that “the primary effective endpoint of a placebo-controlled effectiveness trial should be at least 50 per cent”. “The new crown vaccine is designed to save lives, so it’s understandable to lower the efficiency threshold appropriately.” A researcher at the Shanghai Public Health Clinical Center told First Financial.
In addition, the FDA generally recommends that a sample of pre-licensed safety clinical trial data for preventive vaccines should be at least 3,000 people, and so far, the number of people expected to receive new crown vaccinations in the group has reached 15,000 to 20,000. The FDA acknowledges that adverse events can occur in large-scale clinical trials, so post-marketing regulation is critical.
The FDA also stressed that in vaccine clinical trials, a small number of groups, such as minorities, older groups, and groups at risk of comorbidities, should be given due consideration, and that additional protection searlyes of specific groups, such as children and pregnant women, be given.
The number of new cases of pneumonia in the U.S. is approaching 5 million, but a recent survey of more than 1,000 people found that more than 30 percent of Americans aren’t sure if they will get a new coronavirus; 20 percent have made it clear they won’t get the new coronavirus.
“While the FDA’s procedures can be complex, they can’t afford to be free because the anti-vaccine is already high and it has to be safe and effective before it goes on the market,” a vaccine expert who studies the Ebola virus told First Financial. “
He also said big pharmaceutical companies were aggressively increasing vaccine production capacity, a sign of regulatory pressure. “People are desperate about the outbreak and are eager for a vaccine, but on the other hand they are not optimistic about the effectiveness of the vaccine.” The expert told First Financial.
The potential for effective protection of the new crown vaccine is slim.
U.S. President Donald Trump said this week: “The new vaccine is likely to be available before the U.S. election, before November 3rd.” But that claim has been questioned by Infectious Disease scientists in the United States.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said pressure from the government would not determine when the new vaccine would be approved. Dr. Fauci said on August 7th that the new crown vaccine, even if approved, would not be highly efficient.
Dr. Fauci says it’s generally considered 98 percent more effective and 93 percent effective for a measles vaccine, but the chances of a new vaccine being effective are slim. “Scientists want the new vaccine to be at least 75 percent effective, but it’s acceptable if the result is 50 or 60 percent effective.” Dr. Fauci said Friday in a conversation at Brown University’s School of Public Health.
Dr. Hahn and Dr. Fauci agree that a vaccine can only be relied upon for true group immunity. To that end, the global pharmaceutical giants have begun preparing vaccineproduction. U.S. vaccine company Moderna said in its August 5 earnings report that it had locked in $400 million in vaccine orders and that the U.S. government and Johnson and Johnson and Pfizer had signed $1 billion and $2 billion in vaccine orders, respectively.
Multinationals are also looking to produce vaccines overseas. On August 6, AstraZeneca announced the signingChinese mainland of an exclusive licensing framework agreement with Chinese vaccine manufacturer Kantai Bio, which, as a technology transferee, will ensure that it reaches an annual production capacity of at least 100 million doses of the new crown vaccine AZD1222 by 2020 and expands the vaccine design capacity to at least 200 million doses per year by 2021.
On August 7th Japan’s Takeda Pharmaceuticals announced that it would produce a new crown vaccine from Novavax, a Us vaccine company, and supply Novavax with 250 million doses of the new crown vaccine a year. Novavax’s new crown vaccine has just released preliminary clinical trial data. Takeda Pharmaceuticals’ vaccine production program will receive a capital injection from the Japanese government. In addition, the Japanese government announced the purchase of 120 million doses of vaccine from AstraZeneca, without disclosing the price.
Previously, Takeda Pharmaceuticals has been developing a new crown plasma therapy. “Since the outbreak of the new crown, Takeda Pharmaceuticals has been actively involved in the development of new crown therapy and has formed coVig19, a new crown plasma therapy alliance with 10 other plasma companies around the world,” Dr. Wang Wei, head of Takeda Asia Development Center, told First Financial. “First Financial Reporter learned that the current plasma therapy multi-center clinical trial has been launched, is waiting for regulatory approval.