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Future vaccines depend on shortage test subjects: monkeys

Mark Lewis was desperate to find monkeys. Millions of human lives all over the world were at stake.

Mr Lewis, the chief executive of Bioqual, was responsible for supplying lab monkeys to pharmaceutical companies like Moderna and Johnson & Johnson, which needed the animals to develop their Covid-19 vaccines. But as the coronavirus swept across the United States last year, there were few specially bred monkeys in the world.

Unable to supply scientists with monkeys, which can cost more than $ 10,000 each, a dozen companies found themselves searching for research animals at the height of the pandemic.

“We lost work because we couldn’t deliver the animals on time,” Lewis said.

The world needs monkeys, whose DNA closely resembles that of humans, to develop Covid-19 vaccines. But a global shortage, resulting from unexpected demand caused by the pandemic, has been exacerbated by a recent ban on the sale of wildlife from China, the largest supplier of laboratory animals.

The latest shortage has reignited talks about creating a strategic reserve of monkeys in the United States, an emergency stockpile similar to those maintained by the government for oil and grains.

As new variants of the coronavirus threaten to render the current batch of vaccines obsolete, scientists rush to find new sources of monkeys, and the United States reassesses its dependence on China, a rival with its own biotechnological ambitions.

The pandemic has underscored how well China controls the supply of vital goods, including masks and medicine, which the United States needs in a crisis.

U.S. scientists searched private and government-funded facilities in Southeast Asia as well as Mauritius, a small island nation off the coast of Southeast Africa, for stocks of their favorite test subjects, rhesus macaques and cynomolgus macaques, also known as long-tailed macaques.

But no country can compensate for what China previously provided. Before the pandemic, China supplied more than 60% of the 33,818 primates, mostly cynomolgus macaques, imported to the United States in 2019, according to analyst estimates based on data from the Centers for Disease Control and Prevention.

The United States has as many as 25,000 laboratory monkeys – mostly pink-faced rhesus macaques – in their seven primate centers. About 600 to 800 of these animals have been researched for coronaviruses since the start of the pandemic.

Scientists say monkeys are ideal specimens for coronavirus vaccine research before they are tested on humans. Primates share over 90% of our DNA, and their similar biology means they can be tested with nasal swabs and have their lungs scanned. Scientists say it’s nearly impossible to find a substitute for testing Covid-19 vaccines, although drugs such as dexamethasone, the steroid used to treat President Donald J. Trump, have been tested in hamsters.

The United States once relied on India to supply rhesus macaques. But in 1978, India halted exports after the Indian press reported that the monkeys were being used in military trials in the United States. Pharmaceutical companies have been looking for an alternative.

Eventually, they landed on China.

The pandemic has shattered what had been a decades-long relationship between American scientists and Chinese suppliers.

“When the Chinese market closed, it just forced everyone to turn to a smaller number of animals available,” Lewis said.

For years, several airlines, including major US carriers, have also refused to transport animals used in medical research due to opposition from animal rights activists.

In the meantime, the price of a cynomolgus monkey has more than doubled from a year ago to over $ 10,000, Mr Lewis said. Scientists who are researching cures for other illnesses, including Alzheimer’s disease and AIDS, say their work has been delayed as priority for animals goes to coronavirus researchers.

The shortage has led a growing number of American scientists to ask the government to ensure a constant supply of animals.

Skip Bohm, associate director and chief veterinarian of the Tulane National Primate Research Center outside of New Orleans, said the discussion for a strategic ape reserve began about 10 years ago between directors of national primate research centers. But a stock was never created because of the amount of money and time required to build a breeding program.

“Our idea was a bit like the strategic oil reserve, in that there is a lot of fuel out there that is only used in an emergency,” Prof Bohm said.

But as new variants of the virus are discovered, potentially restarting the vaccine race, scientists say the government must act on the stock immediately.

“The strategic ape reserve is exactly what we needed to treat Covid, and we just don’t have it,” said Keith Reeves, senior researcher at the Center for Virology and Vaccine Research at Harvard Medical School.

But a strong strategic reserve may still be unable to meet the growing demand for laboratory animals, as Chinese researchers have learned. Even with a government-controlled stock of around 45,000 monkeys, Chinese researchers say they are also facing a shortage.

Researchers often collect hundreds of specimens of a single monkey, whose tissues can be frozen for years and studied over long periods of time. Scientists say they get the best out of each animal, but monkeys infected with Covid-19 cannot be returned to live among other healthy animals and must ultimately be euthanized.

In January, Shen Weiguo, general manager of Shanghai Technology Venture Capital Group, told local lawmakers that three major biomedical companies in the city were short of 2,750 research monkeys last year, according to a report in the news media. ‘State. The deficit is expected to grow by 15% per year over the next five years, Mr. Shen said.

Hubei Topgene Biotechnology breeds monkeys for its own research and for export. The United States was previously its main export destination, but the company currently does not have enough animals to conduct its own experiments, said Yan Shuo, sales manager.

“Now it’s not even about the money,” Mr. Yan said. “We don’t even have monkeys to sell overseas.”

The United States has seven national primate research centers, where animals, when not researched, live in colonies with access to the outdoors and enrichment activities. The facilities are affiliated with research universities and funded by the National Institutes of Health. Animal rights activists have long accused centers of abuse, including separating babies from their mothers.

Matthew R. Bailey, president of the National Association for Biomedical Research, said he was preparing to raise the ape shortage with the Biden administration. He said China’s decision to halt exports at the onset of the pandemic was “probably a cautious emergency measure,” but suggested that China could restart exports given what is now known. on the spread of the virus.

China’s Foreign Ministry said the ban did not target specific species or countries.

Once the international situation improves and the import and export conditions are met, “the ministry said in a statement,” China will actively consider resuming the approval of imports and exports and other related work ”.

Experts said the United States must take some responsibility for not having enough research monkeys.

The budgets of the national primate centers have remained stable or declined for more than a decade. Koen Van Rompay, an infectious disease expert at the California National Primate Research Center, said the federal government asked the center to expand its breeding colonies about 10 years ago, but did not give it increased funding, he therefore reduced his colony instead.

“What we’ve done in a number of cases is we’ve given our females birth control,” said Dr. Van Rompay. “So there would be fewer babies born in the spring.”

At a panel hosted by the National Institutes of Health in December 2018, scientists discussed the challenges facing primate supply in America. There was a realization then that “if China decides to turn off the tap, we will be in big trouble,” said Jeffrey Roberts, associate director of the California National Primate Research Center.

Participants “agreed that the need to breed cynomolgus macaques at the national level is critical and could jeopardize biomedical research in the United States as a whole, if not met,” according to a report from the meeting. “They stressed that it may already be too late to meet this need, but that it will certainly be too late in a few months.”

Amber wang and Elsie Chen contributed to the research.

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Shortage warning, researchers seek to stretch vaccine supply

Some states, such as Texas and Florida, have already started offering vaccines to people 65 years of age and older who do not reside in nursing homes, and those of any age with health conditions that increase their risk of die if they contract Covid-19. This has led to a desperate rush among people wanting to get vaccinated.

“People want to know: when is my turn? Does this happen? Where am I going? ”Mrs. Murray said.

Even as distribution wears off, a vaccine shortage looms in the coming months as only two products to date – one developed by Moderna and the other by Pfizer-BioNTech – have been cleared for emergency use. . The two vaccine makers have committed all their doses until mid-year. That still leaves roughly 60 million adult Americans eligible for vaccination.

Officials also have high hopes for a third single-dose vaccine from Johnson & Johnson. The company ends its clinical trial this month and its vaccine could be cleared for emergency use in February. But even if he passes these tests, it is unclear how many more doses will be ready for distribution and when.

With the proper syringes, federal officials hope to extract an additional dose from the Pfizer vials that originally contained only five doses, further stretching Pfizer’s vaccine. But the government has yet to sign contracts to provide enough of these syringes, according to two experts familiar with the vaccine distribution system.

This made the prospect of doubling the supply of Moderna doses even more enticing. Dr Moncef Slaoui, responsible for Operation Warp Speed, told the CBS ‘Face the Nation’ program on Sunday that data from Moderna’s clinical trials showed that people aged 18 to 55 who received two doses of 50 micrograms exhibited an “identical immune response”. at the norm of two doses of 100 micrograms.

Both Dr Mascola and Dr Fauci have confirmed this research.

But Dr Slaoui went further, saying that the FDA and Moderna are already discussing this possibility. The FDA on Monday issued a statement calling the proposal “premature and not firmly anchored in the available science,” although worthy of clinical research.

The discovery cited by Dr Slaoui came from an early Phase 2 clinical trial, which involved 600 people and aimed to test only the immune response, not the vaccine’s effectiveness, according to Dr Fauci and others. He compared the immune response in people given 50 micrograms with those given 100 micrograms.

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Biden promises 100 million vaccines in 100 days, but shortage grows

WASHINGTON – President-elect Joseph R. Biden Jr., setting himself ambitious goals to turn the tide of the coronavirus pandemic, on Tuesday pledged to receive “at least 100 million Covid vaccines in the arms of the American people” during his first 100 days in office, and said he would make it a “national priority” to get children back to school during that time.

The commitment, which Biden made by introducing members of his health team to Wilmington, Del., Is in line with the goals set by President Trump.

But in creating clear benchmarks for himself, Mr. Biden is taking some risk. The 100 million pledge will undoubtedly be kept at the 100-day mark on April 30, and fulfilling it will require no hiccups in the manufacture or distribution of the vaccine and the willingness of Americans to be vaccinated.

Mr Biden’s announcement came as new details emerged about how Pfizer, the pharmaceutical giant whose vaccine could receive regulatory approval in the United States over the weekend, has repeatedly urged the Trump administration to lock in a larger supply. Before the vaccine proved to be highly effective in clinical trials, the administration repeatedly refused the option of expanding its pre-order beyond the 100 million doses it agreed to buy from Pfizer last July. .

The administration is now looking to double the pre-order; otherwise, he will run out of Pfizer vaccine by March, according to people familiar with the discussions. But Pfizer may not be able to deliver more doses to Americans until June, as the company signed deals with other governments, including the European Union, as the Trump administration hesitated.

Pfizer, an American company, could face a backlash from consumers if countries in Europe or elsewhere use its vaccine to save lives while Americans are forced to wait. But Trump administration officials, trying to hedge their bets between six vaccine makers, were unwilling to commit too heavily to Pfizer.

Moderna, based in Cambridge, Mass., Is close to Pfizer and may get clearance for its vaccine this month. Like Pfizer, its federal contract calls for it to deliver 100 million doses by the end of the first quarter.

Both vaccines require two doses, so together these supplies would likely cover 100 million Americans by the spring. Moderna has said he plans to produce at least 400 million more doses next year, but it’s unclear how many the US government could claim.

At a vaccine “summit” on Tuesday at the White House, Mr. Trump signed an executive order that he said “would ensure that the United States government prioritizes the distribution of the vaccine to American citizens before send it to other countries ”. But the order seemed to have few teeth. Mr Trump has also said he will use the Defense Production Act to produce an additional vaccine, but did not specify how.

Mr Biden’s team is apparently relying on Pfizer and Moderna’s commitments to the Trump administration to deliver on Mr Biden’s 100 million vaccine pledge. His advisers note that the pledge is for 100 million doses – not 100 million people vaccinated.

A third vaccine maker, Johnson & Johnson, could release its clinical trial results within weeks, while a fourth company, AstraZeneca, is still recruiting participants to its trial in the United States. Two other companies included in the Trump administration’s emergency vaccine development program, Novavax and Sanofi, have yet to begin clinical trials.

Mr Biden’s vaccination schedule is achievable, experts say, but he can be optimistic.

“Distribution needs to be transparent throughout the United States, which means every state and local health department is coordinating,” said Dr. Leana Wen, former Baltimore health commissioner. “And there is the issue of public trust. So I certainly hope that will happen, but it’s very optimistic.

In addition to the vaccine promise, Mr Biden implored Americans to wear masks during his first 100 days in office and said he would make them a requirement in federal buildings and on planes, trains and buses that cross state lines.

“My first 100 days won’t end the Covid-19 virus – I can’t promise it,” Biden said. But he added, “I am absolutely convinced that in 100 days we can turn the tide of disease and change life in America for the better.”

The senior officials Mr Biden will appoint – including Xavier Becerra, a former congressman who is now California’s attorney general, as a candidate for the post of secretary of health and human services – will face the immediate challenge of slow the spread of the coronavirus, which has already killed more than 285,000 people in the United States and has taken particularly devastating havoc on people of color.

To address these disparities, Biden created a “Covid-19 Fairness Task Force”. It will be led by Dr. Marcella Nunez-Smith, a health equity expert at Yale University Medical School who described the US Virgin Islands, where she grew up, as “a place where people die too often, too young, of preventable diseases. . “

The event was the first time Mr Becerra and other candidates chosen by Mr Biden – some appearing virtually and others in person – had spoken in public alongside him. Most, including Mr. Becerra, a son of immigrants, shared their personal stories. Dr. Vivek Murthy, who will resume his role in the Obama administration as Mr. Biden’s surgeon general, offered greetings from his grandmother.

Dr Anthony S. Fauci, who will be Mr Biden’s chief medical adviser in addition to continuing in his role as director of the National Institute of Allergy and Infectious Diseases, participated via video, saying he should also attending a ceremony for a colleague at the National Institutes of Health, Dr Harvey J. Alter, who had won the Nobel Prize in medicine – “a reminder,” said Dr Fauci, “of America’s place as as a pioneer of science and medicine. “

As Dr Fauci looks forward to serving in his seventh administration, another of the key members appointed by Mr Biden – Dr Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital, who will lead the Centers for Disease Control and Prevention – n never served in government.

She will face the Herculean task of restoring the morale and reputation of an agency that has been silenced and beaten by Trump’s White House.

“Every doctor knows that when the patient codes, your plans don’t matter – you are responding to the code,” said Dr. Walensky. “And when the nation codifies, if you’re called to serve, you serve.”

Also Tuesday, Jeff Zients, the new coordinator of the Covid-19 response. Mr Biden has yet to nominate his candidates for other health care positions, including commissioner of the Food and Drug Administration and director of the Centers for Medicare and Medicaid Services.

Michael D. Shear contribution to reports.