Pfizer announces positive results for Covid-19 vaccine for children

‘Pfizer and BioNTech on September 20 announced positive results from a Phase 2/3 trial of their SARS-CoV-2 vaccine in children aged 5 to 11 years. The researchers found that a 2-dose regimen of 10µg doses administered 21 days apart demonstrated a favorable safety profile and robust neutralizing antibody response. The findings—which are neither published nor peer-reviewed—are a crucial step toward a SARS-CoV-2 vaccine becoming available for younger children, and the companies expect to submit an application to the US FDA for the vaccine’s authorization for that age group by the end of September. US regulators have issued warnings to the general public to wait for authorization before seeking vaccination for younger children, as the full adult dose of 30µg may put children at a higher risk for adverse side effects, including myocarditis.

‘The trial included nearly 2,300 children, and two-thirds of them in the vaccine group. The vaccinated children also were compared with a separate cohort of 16-25-year-old individuals who received the full adult course of the vaccine (2 doses of 30µg). The trial found that the neutralizing antibody response was similar between both vaccinated groups, with the neutralizing antibody levels within 5% of each other. Both groups also experienced similar post-vaccination adverse events.’

Read here (Pfizer news release) and here (Stat News, Sept 20, 2021)

Vaccination reduces risk of long Covid, even when people are infected, UK study indicates

‘People who are fully vaccinated against Covid-19 appear to have a much lower likelihood of developing long Covid than unvaccinated people even when they contract the coronavirus, a study published Wednesday indicated. The research is among the earliest evidence that immunization substantially decreases the risk of long Covid even when a breakthrough infection occurs. Already, researchers had said that by preventing many infections entirely, vaccines would reduce the number of cases of long Covid, but it wasn’t clear what the risk would be for people who still got infected after vaccination.’

Read here (STAT, Sept 1, 2021)

Regeneron says monoclonal antibodies prevent Covid-19 in study

‘Regeneron said Tuesday that its monoclonal antibody cocktail prevented Covid-19 in a clinical trial. The news, issued via a press release, mirrored similar news from Eli Lilly last week that its monoclonal antibody prevented symptomatic Covid-19 infections in nursing homes.

‘The results represent the first 400 volunteers from the study, which is being run by the National Institute of Allergy and Infectious Diseases (NIAID), and is continuing to enroll patients. The volunteers were at high risk of infection because they lived in the same household as a Covid-19 patient. Half the patients received a placebo, and the other half received 1.2 grams of casirivimab and imdevimab, Regeneron’s antibodies.’

Read here (Stat News, Jan 26, 2021)

Eli Lilly says its monoclonal antibody, bamlanivimab, prevented Covid-19 infections in clinical trial

‘Eli Lilly said Thursday that its monoclonal antibody prevented Covid-19 infections in nursing home residents and staff in a clinical trial, the first time such a treatment has been shown to prevent infection. Lilly released the results in a press release, although it said that it would publish the data in a research paper as quickly as possible.

‘In November, the antibody, bamlanivimab, was authorized for emergency use by the Food and Drug Administration in treating patients with Covid who are at risk of more severe disease. An antibody cocktail made by the biotechnology firm Regeneron has also been authorized... But Lilly believes its antibody could be an option not just to treat Covid-19 but to help prevent it in limited circumstances.’

Read here (STAT News, Jan 21, 2021)

Britain takes a gamble with Covid-19 vaccines, upping the stakes for the rest of us: Mixing and matching, and extending interval between doses

‘In an extraordinary time, British health authorities are taking extraordinary measures to beat back Covid-19. But some experts say that, in doing so, they are also taking a serious gamble. In recent days, the British have said they will stretch out the interval between the administration of the two doses required for Covid-19 vaccines already in use — potentially to as long as three months, instead of the recommended three or four weeks. And they have said they will permit the first dose and second dose for any one person to be from different vaccine manufacturers, if the matching vaccine is not available.

‘The moves are borne of a desire to begin vaccinating as many people as quickly as possible, particularly with Britain facing high levels of transmission of an apparently more infectious form of SARS-CoV-2, the virus that causes Covid-19.’

Read here (Stat News, Jan 4, 2021)

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the UK

‘A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

Read here (STAT News, Sept 8, 2020)

First Covid-19 reinfection documented in Hong Kong, researchers say

‘Researchers in Hong Kong on Monday reported what appears to be the first confirmed case of Covid-19 reinfection, a 33-year-old man who was first infected by SARS-CoV-2 in late March and then, four and a half months later, seemingly contracted the virus again while traveling in Europe.

‘The case raises questions about the durability of immune protection from the coronavirus. But it was also met with caution by other scientists, who questioned the extent to which the case pointed to broader concerns about reinfection...

‘During his second infection, the man did not have any symptoms. Some patients go through their course of Covid-19 without showing symptoms, but researchers have also hypothesized that secondary cases of the coronavirus will generally be milder than the first.’

Read here (STAT News, August 24, 2020)

Covid-19 vaccines may cause mild side effects, experts say, stressing need for education, not alarm

‘While the world awaits the results of large clinical trials of Covid-19 vaccines, experts say the data so far suggest one important possibility: The vaccines may carry a bit of a kick. In vaccine parlance, they appear to be “reactogenic,” meaning they have induced short-term discomfort in a percentage of the people who have received them in clinical trials. This kind of discomfort includes headache, sore arms, fatigue, chills, and fever.

‘At least two manufacturers, Cambridge, Mass.-based Moderna and CanSino, a Chinese vaccine maker, stopped testing the highest doses of their Covid-19 vaccines because of the number of severe adverse events recorded among participants in their clinical trials.’

Read here (STAT, July 27, 2020)

Human challenge trials with live coronavirus aren’t the answer to a Covid-19 vaccine

‘With vaccines already a target of widespread misinformation campaigns, the death of a single volunteer would likely cause even greater damage. From a public health perspective, it would be especially disastrous if it both slowed the race to develop a coronavirus vaccine and fueled the anti-vaccination movement. There are other ethical considerations. An important principle in human challenge studies is that subjects must give their informed consent in order to take part. That means they should be provided with all the relevant information about the risk they are considering. But that is impossible for such a new disease.’

Read here (STAT News, June 23, 2020)

To date (July 19, 2020), the 1DaySooner campaign has attracted nearly 33,000 volunteers from 140 countries. Read here

To understand who’s dying of Covid-19, look to social factors like race more than preexisting diseases

‘The Sutter and MIT studies cast doubt on whether individual risk factors are as important as social determinants of health in affecting someone’s chances of contracting severe and even fatal Covid-19. “It should cause us to ask a different set of questions about what puts you at risk of hospitalization or death,” Schwalbe said.

‘More and more evidence is pointing to social determinants of risk, which puts the role of underlying health conditions in a new light. “Comorbidities are still used to blame people for how hard they are hit by Covid-19,” said Philip Alberti, senior director for health equity research at the AAMC. To reduce the U.S. death toll now that many states are seeing a new surge in cases, he said, “our response to this disease” must look beyond the strictly medical.’

Read here (STAT News, June 15, 2020)

Sinovac says early data show its Covid-19 vaccine generated immune responses

‘Sinovac Biotech announced preliminary study results on Saturday showing its experimental Covid-19 vaccine generated immune responses in patients and was safe — early data that suggest it might protect people against infections with the novel coronavirus. The Beijing-based drug maker’s vaccine, called CoronaVac, induced neutralizing antibodies in “above 90%” of people who were tested 14 days after receiving two injections, two weeks apart. There were no severe side effects reported, the company said in a statement. The preliminary results were from a 600-patient, placebo-controlled Phase 2 study. Sinovac is also conducting a 143-patient, placebo-controlled Phase 1 study.’

Read here (STAT News, June 14, 2020)

Immunity to the coronavirus remains a mystery. Scientists are trying to crack the case

‘With Covid-19, immunity — whether from an infection or a vaccine — is expected to wane over perhaps a few years; that is what happens with the four human coronaviruses that cause colds. If that pattern extends to this virus, people will gradually become more susceptible to the virus after some amount of time (though they may be less likely to get a severe case). Tracking the levels of the different correlates could provide clues to how long immunity lasts, and when a person becomes vulnerable again. It could also indicate when people might need another dose of the vaccine.’

Read here (STAT News, June 11, 2020)

The world needs Covid-19 vaccines. It may also be overestimating their power

‘In the public imagination, vaccines are often seen effectively as cure-alls, like inoculations against measles. Rather than those vaccines, however, the Covid-19 vaccines in development may be more like those that protect against influenza — reducing the risk of contracting the disease, and of experiencing severe symptoms should infection occur, a number of experts told STAT.’

Read here (STAT News, May 22, 2020)

Three potential futures for Covid-19: recurring small outbreaks, a monster wave, or a persistent crisis

‘What all three scenarios agree on is this: There is virtually no chance Covid-19 will end when the world bids good riddance to a calamitous 2020. The reason is the same as why the disease has taken such a toll its first time through: No one had immunity to the new coronavirus.

“This pandemic is not going to settle down until there is sufficient population immunity,” slightly above 50%, epidemiologist Gabriel Leung of the University of Hong Kong told a New York Academy of Sciences briefing.

‘Since the world “is far from that level of immunity,” said Osterholm (he estimates that no more than 5% of the world population is immune to the new coronavirus as a result of surviving their infection), “this virus is going to keep finding people. It’s going to keep spreading through the population.” And that, he said, “means we’re in for a long haul”.’

Read here (STAT News, May 1, 2020)

Many US states are far short of Covid-19 testing levels needed for safe reopening, new analysis shows

‘More than half of US states will have to significantly step up their Covid-19 testing to even consider starting to relax stay-at-home orders after May 1, according to a new analysis by Harvard researchers and STAT.

‘The analysis shows that as the US tries to move beyond its months-long coronavirus testing debacle — faulty tests, shortages of tests, and guidelines that excluded many people who should have been tested to mitigate the outbreak — it is at risk of fumbling the next challenge: testing enough people to determine which cities and states can safely reopen and stay open. Doing so will require the ability to catch reappearances of the coronavirus before it again spreads uncontrollably.’

Read here (STAT News, April 27, 2020)

The results of coronavirus ‘serosurveys’ are starting to be released. Here’s how to kick their tires

‘Results from the first studies designed to determine how widely the coronavirus has spread in communities have started to trickle in, drawing immense attention. These studies, after all, are seen as critical indicators of when it might be safe to lift movement restrictions.

‘Already, though, experts are raising concerns about the validity of some of the studies and cautioning officials and the general public not to put too much weight on any one finding.

‘Known as serological surveys, the studies involve testing the blood of people not diagnosed with Covid-19 to determine whether they had previously been infected by the SARS-CoV-2 virus. They are important because they can flesh out the picture of how many people in any given community may have had Covid-19, even if they were unaware they were infected.‘

Read here (STAT News, April 24, 2020)

Download here Q&A from The Wadsworth Center (WC), the public health laboratory of the New York State Department of Health (NYSDOH)

Leaked study data finds no benefits of Remdesivir on coronavirus patients, sending Gilead stock tumbling

‘The World Health Organisation prematurely posted a draft summary of the China-based trial that was seen by STAT News before it was removed, with a WHO spokesperson telling the publication it's still being peer reviewed and finalised.

‘Gilead challenged the results in an emailed statement, however, deeming them "inconclusive" given the clinical trial was ended early resulting in low enrollment, though it noted there were trends suggesting potential benefit for patients who received treatment early.

‘That didn't stop Gilead's stock from diving down 8% to $75.37 a share in the afternoon before recovering slightly to $77.78.’

Read here (Forbes, April 22, 2020)

Everything we know about coronavirus immunity and antibodies — and plenty we still don’t

‘But as the tests roll out, some experts are trying to inject a bit of restraint into the excitement that the results of these tests could, for example, clear people to get back to work. Some antibody tests have not been validated, they warn. Even those that have been can still provide false results. And an accurate positive test may be hard to interpret: the virus is so new that researchers cannot say for sure what sort of results will signal immunity or how long that armor will last.

‘They caution that policymakers may be making sweeping economic and social decisions — plans to reopen businesses or schools, for example — based on limited data, assumptions, and what’s known about other viruses. President Trump last week unveiled a three-phased approach to reopen the country; he said some states that have seen declining case counts could start easing social distancing requirements immediately. And some authorities have raised the idea of granting “immunity passports” to people who recover from the virus to allow them to return to daily life without restrictions.’

Read here (STAT News, April 20, 2020)

Dow futures rally 700 points after Gilead drug reported shows effectiveness. There are reservations about the report and clinical trials funded by Gilead

Dow futures rally. Read here (CNBC, April 16, 2020)

‘Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.

‘The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

‘The lack of a control arm in the study could make interpreting the results more challenging.’

Read here (STAT News, April 16, 2020)