EU Approves Single-Dose Johnson & Johnson Vaccine

Johnson & Johnson’s single-dose coronavirus vaccine gets green light in Europe. The European Medicines Agency, the European Union’s pharmaceutical regulator, approved the Johnson & Johnson COVID vaccine for use in those aged 18 and over, on Thursday.

The European Commission is expected to give the vaccine the official green light for distribution across the bloc on Thursday afternoon.

The US, UK, and Bahrain have already approved the shot and are using it in their inoculation campaigns.

J & J’s one-shot inoculation can be stored in normal refrigerators for up to three months, compared to its two-dose counterparts that require frigid temperatures and expire quickly.

Although the single-dose vaccine is expected to speed up inoculation campaigns across Europe, the bloc will have to wait — the EU is expecting its first batch of a massive 200 million-dose shipment of the shot next month.

This is the fourth vaccine to be approved for use in the European Union, following the shots from Pfizer-BioNTech, Moderna, and AstraZeneca.

The US-developed Novavax, German CureVac, and Russia’s Sputnik V vaccines are all undergoing rigorous trials and are currently awaiting approval from the EU’s drug regulator.

Emer Cooke, Executive Director of the European Medicines Agency, stated Thursday: “With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens.”

Johnson & Johnson vaccine safe and effective

After the J & J vaccine was proven to be highly safe and effective in preventing against coronavirus deaths and hospitalizations, it was OK’d by the FDA, the main drug regulator in the US, for emergency use across the country in late February.

An international study of over 40,000 participants, with half receiving a placebo and the other half the real shot, showed that the Johnson and Johnson vaccine was 66% effective in preventing against moderate and severe cases of the virus.

Experts argue that the single-dose vaccine may seem to be less worthwhile than its double-dose, more effective competitors, simply due to the way the inoculations are tested.

Currently, each shot undergoes its own testing, oftentimes with different methods, making comparisons between the results less fruitful than analyzing each study independently.

In addition, the Johnson and Johnson vaccine was tested in South Africa and other areas where mutations of the virus are especially prevalent, unlike the Pfizer and Moderna shots, which were tested primarily at a time when the original strain of the coronavirus predominated.

Shot greatly reduces deaths, hospitalizations

Considering the prevalence of multiple variants of the virus internationally, the company can’t say with certainty how well the vaccine will protect against each mutation.

However, results from the international study show that the vaccine’s efficacy is impacted by location.

In North America, the shot was 72% effective against moderate and severe cases of Covid-19, while in South America and South Africa, it was just 66% and 57% effective, respectively.

While less effective in preventing the virus than other vaccines, such as the Pfizer and Moderna vaccines, that are 95% an 94% effective, respectively, the Johnson & Johnson vaccine may be integral in reducing Covid-related deaths and hospitalizations.

Of all those who received the vaccine during the trial, not one was hospitalized or died with the virus after becoming inoculated.

The J & J inoculation is a “game-changer”

These qualities make the J & J shot a “game changer,” Dr. Nirav Shah, the prominent epidemiologist who is the head of the Maine Center for Disease Control, stated in a press briefing in early February.

The J & J vaccine “differs in material ways relative to the two candidates that we have right now from Pfizer and Moderna,” Dr. Shah stated. 

“Namely, it’s one dose and it’s a lot more portable…If that vaccine is authorized and made available to states in sufficient quantities, it opens up a brand-new front for us,” he declared.

“It means that vaccine can be distributed much more easily, it can be kept outside that frozen environment for a longer period of time and we can focus in on a population” without having to worry about how those individuals will receive a second dose, he explained.

That could mean bringing inoculation to a “brand-new and different population in some respects than the population in the venues we’re using right now. “That’s not a game-changer — it’s a brand new, different game altogether.”

Johnson & Johnson aims to produce nearly one billion doses of vaccine by the end of the year for distribution worldwide.