Russia probes fake vaccine certificates; Iran reopens to vaccinated tourists after 20 months; Moderna reports positive results for children

Washington: US biotech firm Moderna said on Monday its Covid vaccine was safe and produced a strong immune response in children aged 6-11, adding it would submit trial data to global regulators soon.

The news comes as a panel of government advisors was preparing to meet Tuesday on the question of whether to authorise the Pfizer vaccine in kids aged 5-11, with top infectious disease expert Anthony Fauci predicting it would be available by mid-November.

"We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints," Moderna chief executive Stephane Bancel said in a statement.

An interim analysis from a mid-to-late stage clinical trial of 4,753 children showed that two doses of vaccine produced a high level of neutralizing antibodies -- Y-shaped proteins that bind to the coronavirus and block it from entering human cells.

The vaccine was dosed at 50 micrograms, which is half of what is used among adults, but still produced on average 1.5 times as many antibodies in children as it did in young adults given the higher dose. The majority of adverse events were mild or moderate, including fatigue, headache, fever, and injection site pain.

These early results, released via a press statement, do not yet include a vaccine efficacy estimate, which may be expected at a later time once cases have accrued.

The Moderna news comes as the US Food and Drug Administration (FDA) is preparing to convene a panel of advisors to vote on whether to greenlight the Pfizer shot for younger children, paving the way for 28 million more Americans to be vaccinated.

A briefing document posted on the FDA’s website indicated the agency believes benefits outweigh the most worrying side effect for this age group, namely myocarditis, or heart inflammation.

"The overall analysis predicted that the numbers of clinically significant Covid-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases," the document said.

But it acknowledged the benefit-risk calculus would differ when community transmission is very low, as was the case in the United States in June 2021. The FDA also uploaded Pfizer’s efficacy analysis, with the company estimating a two-dose course of its vaccine at 10 micrograms was more than 90 percent effective in preventing symptomatic disease.

Overall, more than 150 children aged 5 to 11 have died from Covid in the United States since the start of the pandemic, according to official data. "If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November," Fauci told ABC News Sunday.

Meanwhile, Russian authorities were on Monday investigating nurses and a doctor in Saint Petersburg accused of selling fake coronavirus vaccination certificates, as the country faces a deadly new wave.

The Investigative Committee, which probes major crimes, said a doctor and three nurses are suspected of pocketing at least 100,000 rubles ($1,430) from 12 people after selling official certificates without having administered jabs.

The 12 alleged buyers were entered into a state registry of vaccinated people, the Investigative Committee said in a statement on Saturday.

The doctor was briefly detained on Saturday and a court later banned him from leaving the city pending the investigation, a spokesman for Saint Petersburg police, Vyacheslav Stepchenko, told AFP on Monday. Saint Petersburg is Russia’s second most affected city.

Independent polls show that more than half of Russians do not plan to get a shot, and the proliferation of fake jab certificates has been a persistent problem.

Infection rates have soared in recent weeks amid a stalled vaccination campaign, with just over 30 percent of the country fully inoculated despite several widely available vaccines including Sputnik V.

In a related development, Iran has reopened its doors to tourists vaccinated against Covid-19 after almost 20 months of closure due to the pandemic, media in the Islamic republic said on Monday.

The country’s anti-virus taskforce approved the reopening on the advice of the tourism ministry, an official was quoted as saying on the ministry’s website.

The Middle East country hardest hit by the pandemic had shut its borders to foreigners in March 2020, with the exception of medical and business trips.

The average number of international trips to and from Iran decreased by 80 percent in the year to March 20, 2021, according to the customs administration.

Meantime, the EU’s drug watchdog on Monday approved booster doses of Moderna’s Covid vaccine for all people aged 18 and over, amid concerns that protection levels dip after initial jabs.

Spikevax is the second booster to be given the green light after Pfizer/Biontech’s vaccine, which received the green light earlier this month.

"Data showed that a third dose of Spikevax given 6 to 8 months after the second dose led to a rise in antibody levels in adults whose antibody levels were waning," the European Medicines Agency said.

Earlier on Monday, the EU’s medicine watchdog said on Monday it had started reviewing an oral Covid medication from the US pharmaceutical firm Merck, raising hopes for an easy-to-administer treatment to reduce serious or deadly cases. The move, which could eventually lead to authorisation on the European market, comes two weeks after Merck applied for emergency use in the US of the anti-coronavirus drug.