The pharmaceutical company AstraZeneca said on Saturday that it had resumed its coronavirus vaccine testing in the UK after suspending it six days earlier on potential safety issues, but tests were still ongoing in the United States and other countries.
On the same day news came that a competitor, Pfizer, said it was expanding its test of the coronovirus vaccine to 44,000 people – a major increase from its previous target of 30,000 – in an effort to recruit a more diverse group of participants In and potentially below the time required to obtain results from the cut test.
Together, the event raised new questions about when a vaccine might be available and showed how unpredictable vaccine development could occur, even as the world eagerly awaited something that would end the epidemic. Can.
Both companies’ announcements lacked critical details, prompting criticism that they were not opening enough about the data they are collecting. AstraZeneca did not provide any information to partially support the decision to resume the trial nor provide any details about the illness of a patient who had caused the suspension. Pfizer did not explain how it would determine the vaccine’s effectiveness in its extended trials.
A professor of molecular medicine at the Scripps Research Institute in San Diego and an expert on clinical trials, Drs. Eric Topol found both announcements worrying, stating that companies were withholding important information.
“The public has the right to know what’s going on,” he said. “The future depends on it.”
AstraZeneca and Pfizer are among three companies currently testing their candidates in late-stage clinical trials in the United States – Morden is the third – to develop a coronovirus vaccine in a record-setting race. All three have said they expect a vaccine to be ready – at least for high-priority groups – before the end of the year. On Saturday, Pfizer reiterated previous statements that there may be an answer as to whether its vaccine works until the end of October.
All three have also made billions of dollars in deals with the United States government, either to support their research or to provide a supply of their vaccines that they must prove safe and effective.
[Follow the push for a coronavirus vaccine with The Times’s vaccine tracker.]
The fast-paced hunt for a vaccine has come under scrutiny as President Trump has pushed swiftly to prepare before the election on November 3, raising concerns that he was politicizing the process is. This concern has prompted companies to make extraordinary pledges to follow science, as are top federal regulators. Americans have shown reluctance to take a vaccine that they see as too hasty, putting additional pressure on companies to show that they are acting properly.
In Phase 3 final phase trials, vaccine developers typically include tens of thousands of volunteers. Half of the participants receive a placebo, and half receive the vaccine. The researchers closely monitored the participants for side effects.
Last Sunday, AstraZeneca postponed its trial after a participant became seriously ill in the UK. The company did not announce the decision. On Wednesday, news agency Staat was quoted as saying that the trial had been halted, with AstraZeneca issuing a statement, describing it only as a “potentially unexplained disease”.
The New York Times reported that a person familiar with the condition, who spoke on condition of anonymity, said that the symptoms were consistent with spinal cord inflammation, known as transverse myelitis. The condition can be treated and usually resolves in a few months, but severe attacks can cause major disability.
Announcing the resumption of the trial in the UK on Saturday, AstraZeneca said an external panel of experts had reviewed the case and told the British Government’s Medicine and Healthcare Products Regulatory Authority to resume the trials can go. The authority agreed to give the green light for the restart.
The British Health Secretary, Matt Hancock, celebrated the restart.
He said, “Good news for everyone: The trial of the Oxford vaccine is back up and running.” “This stagnation shows that we will always have safety first. We will return our scientists to deliver an effective vaccine as soon as possible. “
Michel Meisel, a spokesperson for AstraZeneca, said the company could not reveal any further medical information about the ailing volunteer.
“All test investigators and participants will be updated with relevant information and disclosed on global clinical registries,” he said in an email.
Ms Mikesell did not say that she expected testing to begin in other countries. “AstraZeneca will continue to work with health authorities around the world and will be guided when others can resume clinical trials,” she said.
Ms Meixel said the company did not anticipate that the stagnation would delay obtaining results from testing before the end of the year.
Refused to comment on the status of AstraZeneca’s trial in the United States, Stephanie Cacomo, director of media relations for the Food and Drug Administration, declined to comment. She said in the email, “FDA cannot comment on the product’s applications, nor confirm nor test the products.”
Dr. Topol, who has undergone clinical trials to treat the heart, said it was for him to be kept regular and restarted.
But AstraZeneca’s and Oxford’s public statements about why the lawsuits in the UK are going ahead surprised him. “Why would it move forward in a country?” he said. “We are all people. This is strange. “
So far, Pfizer and its partner BioNotech have not reported any symptoms in their participants that would require stagnation in their testing. In a statement on Saturday, Pfizer said the company hopes to reach its initial target of 30,000 volunteers next week.
The company said it had requested FDA approval to expand the trial to 44,000 participants to include more people with diseases such as HIV and hepatitis B and C. The company is also expanding its criteria to include people at the age of 16.
Amy Rose, a Pfizer spokesperson, said additional volunteers could be recruited in any of the countries where the trials are taking place, including Argentina and Brazil. “We will continue to actively recruit all eligible individuals where the incidence and prevalence of COVID-19 cases is greatest,” he said in an email.
She also said that a larger test could allow Pfizer to achieve those results soon.
“Enrolling more participants gives us more flexibility and allows us to access the number of cases needed to complete the study faster,” she said.
Dr. Topol said he was unlikely that Pfizer could achieve full results from a trial of 44,000 people by the end of October, noting that the vaccine required two separate doses for three weeks. It was possible, he said, that Pfizer intended to see the initial results of the trial to see how effective the vaccine was.
An external committee of experts may evaluate clinical trials at various points in the study. The panel may also advise the company to stop the trial if it shows heavy efficacy, if it fails to stop the Kovid-19 cases or if there were serious safety concerns. Pfizer has not said when the so-called interim analysis will take place or what the criteria are for stopping the test.
“We are not going to discuss the timing or nuances of any interim analysis,” said Ms. Rose, a Pfizer spokesperson.
Dr. Topol warned that because Pfizer has reiterated its goal of achieving results by October as it is hiring new participants, “What we are seeing here from this Pfizer news release is that they are fully tested.” Intends to disrupt. “
On Tuesday, Pfizer and eight other companies that are developing coronovirus vaccines have signed a pledge that they will wait to vaccinate a vaccine until evidence is clear for safety and efficacy.
“We are committed to running our tests with scientific excellence and integrity,” Ms. Rose said.