Vaccine updates: Finish line in sight? What you need to know

Pfizer, BioNTech target October regulatory review for vaccine

US drug maker Pfizer and its German biotechnology partner BioNTech shared positive early data from the Phase 1 study of their COVID-19 vaccine candidate, BNT162, which advanced into Phase 2/3 evaluation late last month.

Based on the messenger RNA (mRNA) platform – which only mimics a SARS-CoV-2 genetic component, but not using real virus to prepare the vaccine – BNT162 is one among seven candidates that are now in late stage clinical trials.

The companies said seven days after a second dose, both younger and older adults had higher levels of antibodies than recovered patients, and the vaccine was well tolerated across all populations with mild to moderate fever in fewer than 20% of the participants.

“Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020, and if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021,” said the press release.

The US government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses.

On August 20, 2020, Johnson & Johnson confirmed that it is planning the largest Phase 3 study of a COVID-19 vaccine we’ve seen yet. It is enlisting 60,000 people around the world for the late stage trial which is expected to begin by late September. Its Phase 1/2a clinical trial started last month.

If a vaccine (or vaccines) will be approved, would people be confident enough to take it?

It’s a big challenge for scientists, especially with regards to side effects: 35% or one in three Americans would not get a free, FDA-approved vaccine if ready today, according to a Gallup poll conducted between July 20-August 2.

Australian Prime Minister Scott Morrison said earlier that he would “expect it to be as mandatory as you could possibly make it” with few exceptions – but was forced to backtrack that same day due to the backlash.

Argentina joins Chinese coronavirus vaccine trial, maker says

BEIJING: Argentina joined Peru, Morocco, Brazil and the United Arab Emirates in approving Phase 3 clinical trials for a coronavirus vaccine developed by China National Biotec Group (CNBG), the company said late Friday.

As China forges ahead in the global race to develop a vaccine to curb the COVID-19 pandemic and as cases within China dwindle, CNBG needs research participants from other countries for testing.

Phase 3 trials, which usually involve several thousand participants, allow researchers to gather data on the efficacy of potential vaccines for final regulatory approvals.

CNBG will partner with Argentina’s ELEA in the vaccine trial, the Chinese company said in a statement late Friday.

The experimental vaccine by CNBG, a unit of state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm), received approval from the UAE in June for a Phase 3 trial and has since recruited 15,000 volunteers.

The company said on Thursday that Peru and Morocco also approved the trials. CNBG has also obtained approval from Bahrain for a Phase 3 study designed to involve around 6,000 participants.

Moderna says more than 40% of participants enrolled for final COVID-19 vaccine trial

Drug developer Moderna Inc said it has so far enrolled 13,194 participants in the ongoing late-stage 30,000-volunteer US trial testing its COVID-19 vaccine candidate.

In a tweet, the company also said that 18% of the participants currently enrolled are Black, Latino, American Indian or Alaska Native, groups among the hardest hit by the coronavirus virus pandemic.

Moderna began the study of its vaccine candidate, mRNA-1273, in July and expects to complete enrollment in September.

30,000 subjects target

The 30,000-subject US trial is among the first late-stage studies supported by the Trump administration’s effort to speed development of measures against the novel coronavirus, adding to hope that an effective vaccine will help end the pandemic.

Last week, the company entered a supply agreement with the US government to provide 100 million doses of its potential COVID-19 vaccine for around $1.5 billion.

Moderna, which has never brought a vaccine to market, had earlier received nearly $1 billion from the US government, which is helping bankroll several vaccine candidates under its Operation Warp Speed program.

Russia approves trial of AstraZeneca COVID-19 vaccine

MOSCOW: Britain’s AstraZeneca has received regulatory approval to conduct part of a Phase III trial of its potential COVID-19 vaccine in Russia, a filing in the Russian registry of clinical trials showed on Friday.

The trial of the AZD1222 vaccine will involve 150 participants and will be handled by four medical facilities in St. Petersburg and Moscow, the filing, dated Friday, showed.

Moscow has previously agreed a deal with AstraZeneca to manufacture the potential vaccine, developed in tandem with Oxford University, at the facilities of Russian firm R-Pharm.

The British drugmaker said in a statement last week that late-stage trials of its vaccine were ongoing in Britain and in Brazil, an early-stage trial was progressing in South Africa, and that further trials were planned in the U.S., Japan and Russia.

Russia is also developing several potential COVID-19 vaccines domestically, with late-stage trials of the front-runner candidate, nicknamed ‘Sputnik-V’, set to begin next week.

Nearly 20% of COVID-19 vaccine trial subjects are Black or Latinos

CHICAGO/NEW YORK: Nearly a fifth of 11,000 people enrolled so far in a 30,000-volunteer US trial testing a COVID-19 vaccine from Pfizer and German partner BioNTech are Black or Latino, groups among the hardest hit by the coronavirus virus pandemic, a top Pfizer executive said.

“Between Latinos and Black or African American populations, we’re running at about 19 percent or so,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told Reuters in an interview.

“We’re trying to push even higher than that.”

Black and Latino Americans are infected with COVID-19 at more than twice the rate of white Americans, with Native Americans infected at even higher rates, research has shown. The groups are historically underrepresented in clinical trials.

The companies’ vaccine has quickly advanced into late-stage testing, with some participants already getting their second of two doses.

Physicians and scientists have been urging companies testing coronavirus vaccines to include Black, Latino and indigenous Americans in COVID-19 vaccine trials in hopes of building trust among at-risk populations.

Higher attack rates

“We have a lot of campaigns to reach out to those communities because they are overrepresented in terms of COVID-19 illness, so we are very keen to have those individuals as part of our trial,” Gruber said on Thursday. “They have higher attack rates and they are most likely to benefit.”

According to a Reuters/Ipsos poll in May, only half of Black Americans said they were somewhat or very interested in taking a COVID-19 vaccine.

Gruber did not disclose the number of Native Americans enrolled in the trial, but said Pfizer plans to draw on ties from its Prevnar 7 pneumococcal vaccine tests in the southwestern United States.

“I’m hopeful we’ll be able to make further inroads in that community as well,” he said.

Pfizer and BioNTech expect to have data sufficient for an emergency use authorization (EUA) or to start a full submission in October, according to Gruber.

The company does not need to finish recruiting the full 30,000 patients planned for the trial in order to have enough data to support an EUA, he said.

At least 3,000 individuals needed

The U.S. Food and Drug Administration (FDA) has said COVID-19 vaccine trials need to have a safety database of at least 3,000 individuals for each of the younger and elderly populations in which it is tested.

Ultimately, the speed with which the vaccine can be approved depends on how quickly patients in the placebo arm become infected with the virus, starting about a week after the second dose is administered. That began this week.

“We won’t really know until we get a little farther,” Gruber said.

“We’re following the rules that assure rigor,” he added, saying the company was taking no short cuts.

“I can’t tell you what will happen politically,” Gruber said, when asked about concerns the Trump administration might pressure companies and regulators to announce progress before the November election.

Gruber said the companies were now in talks with the FDA about how to begin testing the vaccine in children, a group the regulatory agency itself is eager to gather data on.

Vaccines work differently in children and adults.

Gruber said vaccine tests often progress in stages, first in older adolescents, then younger adolescents, and finally in children. But there are already signs younger adults have higher rates of reactions, such as fevers and sore arms, to Pfizer’s vaccine than older adults do, Gruber said.

There is a risk those reactions could be even more heightened in younger populations, he added.

Roughly 75% of adults between the ages of 18 to 55 in Pfizer’s most recent trial had fevers after being given the vaccine, most of them mild, according to Gruber.

Younger children – maybe that’s not going to be tolerated.

Maybe we’re going to have severe fevers,” he said. “That’s why we’re adopting a very thoughtful, graduated approach. Children are not just small adults.” Gruber said the company is submitting safety data to the FDA and working out a testing plan for children, which he expects to start soon.

Indonesia books 50 million coronavirus vaccine doses from Sinovac

JAKARTA: China’s Sinovac Biotech has committed to provide 50 million doses of a coronavirus vaccine candidate to Indonesia’s government from November to March, a minister and Indonesia’s state-owned pharmaceutical company Bio Farma said.

The Southeast Asian nation is seeking to secure a supply as cases rise unabated.

During a visit to China, Indonesian Foreign Minister Retno Marsudi said a preliminary agreement had been signed with Sinovac for bulk purchase and supply of the vaccine, CoronaVac, from November to March, after which Indonesia’s state-owned Bio Farma would get priority access until end-2021.

Indonesia has recorded 149,408 coronavirus infections and 6,500 deaths and is keen to secure a vaccine for its 260 million people and develop its own, amid concern among some developing countries about competition for access.

“Indonesia sees a strong commitment from China’s industries to forge partnerships and a strong commitment from its government to foster those partnerships,” she said late on Thursday via video.

Sinovac did not immediately respond to a request for comment on Friday and Bio Farma said in a statement on Friday evening that the 50 million bulk would come in stages: 10 million for each month starting in November. Marsudi said on Thursday that the doses had been 40 million.

Phase III trials for Sinovac’s CoronaVac began last week in Indonesia involving 1,620 volunteers.

Bio Farma is involved in the development of the vaccine and has said Indonesia should have capacity to produce 250 million doses a year by the end of 2020, pending human trials.

In an interview with Reuters on Wednesday, research minister Bambang Brodjonegoro said Indonesia was developing its own COVID-19 inoculation, dubbed the “red and white” vaccine after the colours of the national flag.

Brodjonegoro expected production by Bio Farma to start sometime in 2021.

“Obtaining vaccines entails risk, uncertainty,” he said.

“Even if there are other countries or parties who have found effective vaccines, we need to make our own vaccine for COVID-19.”

Russia vaccine roll-out plan prompts virus mutation worries

LONDON: Russia’s plan to roll-out its “Sputnik-V” COVID-19 vaccine even before full trials show how well it works is prompting concern among virus experts, who warn a partially effective shot may encourage the novel coronavirus to mutate.

Viruses, including the pandemic SARS-CoV-2, are known for their ability to mutate all the time – and often this has little or no impact on the risk posed to people.

But some scientists are worried that adding “evolutionary pressure” to the pathogen by deploying what might not be a fully protective vaccine could make things worse.

“Less than complete protection could provide a selection pressure that drives the virus to evade what antibody there is, creating strains that then evade all vaccine responses,” said Ian Jones, a virology professor at Britain’s Reading University.

“In that sense, a poor vaccine is worse than no vaccine.”

Sputnik-V’s developers, as well as financial backers and Russian authorities, say the vaccine is safe and that two months of small-scale human trials have shown that it works.

But the results of those trials have not been made public, and many Western scientists are sceptical, warning against its use until all internationally approved testing and regulatory hurdles have been passed.

Russia said on Thursday it plans to begin a large-scale efficacy trial of the vaccine in a total of 40,000 people, but will also begin administering it to people in high-risk groups, such as healthcare workers, before the trial has produced any results.

“You want to make sure the vaccine is effective. We really don’t know that (about the Sputnik vaccine),” said Kathryn Edwards, a professor of paediatrics and vaccine expert in the infectious diseases division at Vanderbilt University School of Medicine in the United States.

She said that the risk of what a vaccine might do to a virus – in terms of fighting it, blocking it, or forcing it to adapt – is “always a concern”.

Dan Barouch, a specialist at Harvard’s Beth Israel Deaconess Medical Center in Boston, noted that mutation rates for coronaviruses are far lower than for viruses like HIV, but added: “There are many potential downsides of using a vaccine that doesn’t work. The risk that it (the virus) would mutate is a theoretical risk.”

Scientists say similar evolutionary pressure to mutate is seen with bacterial pathogens, which – when faced with antibiotics designed to target them – can evolve and adapt to evade the drugs and develop resistance.

Antibiotic resistance and the rise of superbugs, is described by the World Health Organization as one of the biggest threats to global health, food security and development today.

Jones stressed that vaccine-induced viral mutations are “a rare outcome”, and the greater the efficacy of the vaccine in blocking a virus’ ability to enter cells and replicate there, the lower the risk of it having an opportunity to circulate and “learn” how to evade antibody defences.

“If (a vaccine) is completely sterilizing, the virus can’t get in, so it can’t learn anything because it never gets a chance,” he said. “But if it gets in and replicates … there is selection pressure for it to evade whatever antibodies have been generated by the inefficient vaccine. And you don’t know what the outcome of that will be.”

COVID-19 era highlights US ‘black hole’ compensation fund for pandemic vaccine injuries

A U.S. government program that compensates people who say they have been harmed by an emergency vaccine has paid out on fewer than 10% of claims, raising questions whether the process should be used to address any potential side effects from a coronavirus shot, according to some lawyers who have filed such claims.

The Countermeasures Injury Compensation Program (CICP), run by an agency under the U.S. Department of Health and Human Services (HHS), has been designated to handle any issues with a COVID-19 vaccine.

The lawyers say the program is inadequate for addressing fast-tracked coronavirus vaccines.

They say that any COVID-19 vaccine injuries should be handled through a different HHS program known as the “vaccine court,” a more transparent process with a better record of compensating people for the rare injuries or serious side effects from routine inoculations, such as measles shots.

The National Vaccine Injury Compensation Program (VICP) covers claims regarding 16 routine vaccines recommended by the Centers for Disease Control and Prevention (CDC).

Vaccine injury litagation 

When it comes to addressing any potential harm from a COVID-19 vaccine, “there are major deficiencies that need to change” in the U.S. approach, said Peter Meyers, an emeritus professor at George Washington University School of Law and former director of the Vaccine Injury Litigation Clinic.

Meyers described the CICP as a “black hole” process handled entirely within HHS, rather than a court, without fees for attorneys or expert witnesses, a short one-year window to file claims and limited participation by the claimant.

HHS declined comment on criticisms of using CICP to process potential COVID-19 claims.

Drugmakers including Moderna, Pfizer and AstraZeneca are working to deliver a safe and effective vaccine against COVID-19 as early as this year, compressing years of development into months.

The effort has raised concerns among many Americans that a vaccine may be introduced to tens of millions of people before the potential risks are fully known.

Shields drugmakers

The US system shifts liability for vaccines to the government, and shields drugmakers, because widespread inoculation against disease is considered a benefit to society.

While billions of vaccine doses have been administered in the United States over the past 30 years, government data shows that around 1 person in a million suffers a serious injury that warrants compensation.

Congress set aside $30 billion this year for HHS to fight COVID-19, including funding vaccine development and possibly any necessary compensation. So far, no claims regarding COVID-19 drugs have been filed with CICP and the program has not requested specific funding, an HHS spokesperson said.

Of 485 claims filed since CICP began reviewing claims in 2010, only 39 people have received compensation for a total of $5.7 million, according to the Health Resources & Service Administration (HRSA), which runs the program for HHS.

Almost all of the claims involved H1N1 pandemic flu vaccines, according to information obtained by Meyers through a Freedom of Information Act request. The CDC estimates about 123 million people over the age of six months received the vaccine for H1N1, also known as swine flu.

“It’s not fair to people on the frontlines, if they are the first to get this vaccine and they have to go to the CICP and get little to nothing,” said Renee Gentry, the director of the Vaccine Injury Litigation Clinic.

U.S. officials have said the first people to receive a successful COVID-19 vaccine would include healthcare workers and people at high risk of complications from the virus.

An HRSA spokesman said the CICP denies claims for a variety of reasons, including the legal requirement there be “compelling” scientific evidence that a vaccine directly caused injury. CICP only covers medical costs and lost income not covered by others, such as private health insurance.

Help or harm?

The programs are considered crucial by drugmakers, protecting them from liability in the U.S. market where lawsuits over products have cost them billions of dollars.

Pfizer, which is working on a COVID-19 vaccine with Germany’s BioNTech, expects the U.S. system to provide a blueprint for dealing with liability in other countries.

“We’re pursuing similar liability protections outside the United States through contractual and/or legislative efforts, and we believe this is going to be manageable,” Pfizer general counsel Doug Lankler told investors last month.

AstraZeneca said it has received protection from liability for its COVID-19 vaccine from most of the countries it has struck supply agreements with.

People who suffer serious injuries from an emergency vaccine in the United States are required to first seek compensation through the CICP, and then, if they decline any award, they can bring a case in court. However, they have to prove a drugmaker acted with “willful misconduct,” which lawyers said would make a case nearly impossible.

Lawrence Karol, 70, of Encino, California developed large fatty cysts after getting a vaccine against H1N1 in 2009. It took him nearly a year to find where to file a claim for up to $10,000 in lost income and the cost to remove a baseball-sized growth from his arm where he received his shot.

By the time he got a hearing, he was told the one-year time limit for claims had passed. The hearing judge said he had no recourse but one: “They told me to go to Congress to change the vaccine statute of limitation laws,” he said.

Gentry of the Vaccine Injury Litigation Clinic said that COVID-19 vaccines should fall under the VICP. The fund has paid out an average of $216 million annually to an average of 615 claimants each year since 2015, according to HRSA.

Attorneys said the VICP pays on about 75% of claims. Cases include witness testimony, public rulings and appeals through the federal court system.

The VICP is funded by an excise tax on vaccine doses, and pays fees for attorneys and experts, so claimants often have legal representation.

VICP cases can take years, but Gentry said it’s still an improvement on the CICP program which she described as “the right to file and lose.”

Papua New Guinea bars Chinese workers over virus risk: Paper

BEIJING/MELBOURNE: Papua New Guinea has denied entry to Chinese nationals who participated in a COVID-19 vaccine trial, the Australian newspaper said on Friday, as the Pacific nation battles a worsening outbreak of the respiratory disease.

The workers had been due to fly from the northern city of Tianjin to the Ramu NiCo plant in northern Papua New Guinea run by state-run Metallurgical Corporation of China Ltd (MCC) .

The Australian said David Manning, Papua New Guinea’s head of disaster management, denied access for the workers after being told of the vaccinations, however, and sent a strongly worded letter to China’s ambassador, Xue Bing.

“The government of PNG demands and deserves to fully understand (the) vaccine development and SARS-CoV-2 vaccine immunisation program undertaken in China and its potential risks,” the Australian quoted Manning as saying, before Chinese travel requests could be approved.

“The Ramu workers didn’t get a Papua New Guinea entry permit,” a source with knowledge of the plant’s operations told Reuters on condition of anonymity. “The Tianjin flight was cancelled and employees have gone back home to rest.” A senior Ramu official, who asked not to be identified, added, “Production is normal. There is no staff shortage problem.”

In Beijing, foreign ministry spokesman Zhao Lijian told a regular briefing he was not aware of the matter. China’s MCC did not immediately respond to an emailed request for comment.

Ramu had told Papua New Guinea health authorities that 48 staff received the SARS-CoV-2 vaccine on August 10, PNG news station NBC said.

Health officials are on tenterhooks after a steep jump in infections in the past month threatens to overun the healthcare system in Papua New Guinea, which largely avoided the first wave.

A further death took the official toll to four, with two new cases pushing the tally of infections to 361 by Thursday, Manning said in a statement.

However, health officials fear the real number could be much higher, as infections spread to regions beyond the capital of Port Moresby.

“The national department of health (NDoH) has not approved any vaccine trials in PNG,” Manning said on Friday.

“Any vaccines imported into PNG must be approved by NDoH and must go through vigorous vaccine trials, protocols and procedures,” he said in a statement, adding that trials must also be approved by the World Health Organization.

Trial for second Russian vaccine ‘to be done by September’

MOSCOW: The clinical trial of a Russian COVID-19 vaccine being developed by the Siberian Vektor research centre is due to be completed in September, the RIA news agency cited Russia’s healthcare watchdog as saying on Friday.