How are vaccines developed?

November 12th, 2014 (last updated)

Before a vaccine is developed it undergoes rigorous testing. Vaccines are subject to even tougher standards than medicines – more people are included in clinical trials and safety standards are very high.

A new vaccine is first tested in a very small group of people to rule out major safety problems and helps doctors work out the right dose.

Next it is tested in a larger group to check that the vaccine works consistently, and scientists watch for any side effects.

Then the vaccine is tested in tens of thousands of healthy volunteers. This shows whether the vaccine protects against natural infection and gives a better chance of discovering rare problems not seen in smaller studies.

But it doesn’t end there. If the vaccine passes all of these tests and is approved by regulators it is continuously monitored.

The vaccines available to use today have been given to millions of people, preventing illness and saving lives.

Source:
Vaccines Today

Vaxart’s Tablet Vaccine for H1N1 Influenza Generates Protective Immunity Equivalent to Injectable in Phase I Clinical Study

November 10th, 2014 (last updated)

Vaxart, Inc., a privately held, clinical-stage company developing recombinant vaccines that are administered by tablet rather than by injection, today announced clinical results demonstrating that its H1N1 tablet vaccine generates protective immunity comparable to currently licensed influenza vaccines, as measured by hemagglutinin inhibition assay (HAI), the established correlate of protection. Vaxart’s founder and chief scientific officer, Sean Tucker, PhD, discussed the data in a presentation today at the 15th Annual World Vaccine Congress in Brussels.

vaccine tablet

“A tablet vaccine for flu could significantly change the way we administer vaccines,” said John J. Treanor, MD, Chief of Infectious Diseases at the University of Rochester Medical Center. “Every year, more than 100 million Americans visit their pharmacy, clinic or private practitioner to receive a flu shot. In contrast, a tablet vaccine could be brought directly to the user, such as in the workplace or at school, and avoids the need to worry about needles. A tablet vaccine might also be manufactured and distributed faster than current injectable vaccines, a factor that could be critical when responding to a pandemic or outbreak. These results look very promising and I am eager to hear more about the continued progress of Vaxart’s programs.”

The data were generated in a phase 1 clinical study of Vaxart’s tablet vaccine candidate for H1N1 seasonal influenza. The randomized, double-blind, placebo-controlled study enrolled 24 healthy volunteers of ages 18-49, who received either placebo or vaccine in tablet form in a single administration.

In the study, 75 percent of subjects (9 of 12) taking the Vaxart H1N1 tablet vaccine fully seroconverted as measured by HAI, a response rate equivalent to those reported for licensed injectable vaccines. HAI geometric mean titers increased 7.7-fold, also within the range of injectable vaccines. None of the subjects receiving placebo (0 of 12) seroconverted. HAI titers are an important standard for determining protective immunity used by industry and the U.S. Food and Drug Administration (FDA).

In addition, the Vaxart H1N1 tablet vaccine induced four-fold increases in neutralizing antibody titers in 92 percent of subjects (11 of 12) as measured by microneutralization (MN) titers, an increasingly recognized marker of protective immunity, versus 0 percent (0 of 12) in the placebo group. MN geometric mean titers rose 23-fold, exceeding rate increases reported for most injectable vaccines. The vaccine also generated strong mucosal and cellular immune responses in 92 percent of subjects, suggesting the Vaxart tablet vaccine could offer broader protection than currently licensed influenza vaccines.

The vaccine exhibited an excellent clinical safety profile, with only mild adverse events that were distributed evenly between the placebo and vaccine groups.

“Our tablet flu vaccine generated broad immune responses in more than 90 percent of recipients, while a remarkable 75 percent seroconverted by HAI, the accepted correlate for protective immunity”, said Vaxart CEO Wouter Latour, MD. “We are seeing a safety-immunogenicity profile that could compete with that of any of the currently marketed vaccines, even without taking into account the convenience and logistical advantages of our room-temperature stable and user-friendly tablet. In addition, our tablet vaccine could significantly increase vaccination rates, currently at about 45 percent of the U.S. population.”

Dr. Tucker discussed the Vaxart data in his presentation, “High titer neutralizing antibody and potent cellular immune responses to influenza in humans after oral immunization with recombinant adenovirus expressing HA.” He further commented, “In addition to the robust HAI and MN responses, our tablet vaccine generated strong mucosal and T cell responses in virtually all recipients (11 of 12). This suggests that the platform technology could be exploited across a wide range of vaccine indications. Accordingly, we are accelerating our non-flu programs and expect to enter the clinic with at least two new indications in 2015.”

Source:
Vaxart

First moments for Pampers/UNICEF: “one pack = one life saving vaccine”

November 8th, 2014 (last updated)

Source:
Happy Healthy Mumma

Russian HIV vaccine heading for phase II trials

November 7th, 2014 (last updated)

HIV vaccine

A candidate HIV vaccine developed in Russia is on the brink of starting phase II trials but could be stymied by a lack of funding, according to the researchers behind the project.

Valery Mikheyev of the Russian State Center of Virology and Biotechnology (Vector) based in Novosibirsk told a press briefing this week that the $5m-$7.5m in funding for the trial of CombiHIVvac still needs to be approved by the government, reports the RIA Novosti news agency.

The vaccine – which is synthetic and based on several DNA and protein HIV antigens or epitopes – is one of three candidates being developed by Russia’s state-funded scientific research institutions and has already cleared phase I trials started by Vector in 2010.

In preclinical studies, it was shown to induce an antibody and cytotoxic T lymphocyte (CTL) responses in mice, with antibodies that were deemed to be highly specific and are able to neutralise HIV-1 in vitro.

Mikheyev told reporters that the phase II trials planned for CombiHIVvac could take around two years to complete, provided funding can be found. It is “Russia’s only vaccine against AIDS to reach the second phase of clinical trials,” he added.

Efforts to develop an effective vaccine against HIV have so far proved fruitless, with a phase III programme for VaxGen’s AIDSVAX candidate ending in failure in 2004 and another study (NVTN 505) of a so-called ‘prime-boost’ vaccination approach dropped due to lack of efficacy in 2013.

To date, the only candidate showing any promise is RV144, which exhibited a modest level of protection in a Thai study reported in 2009 but needs additional research before it could be considered a vaccine candidate suitable for licensing.

The International AIDS Vaccine Initiative (IAVI) is supporting work on eight vaccines in total, but so far none have progressed beyond early-stage clinical testing.

Researchers are now studying the molecular structures of antibodies shown to have potent HIV-1-neutralising effects in a bid to reverse-engineer vaccines that might elicit similarly effective responses.

Source:
PMLive

HPV Vaccine does not cause multiple sclerosis

November 6th, 2014 (last updated)

Vaccines have been associated with autism and various other conditions and diseases. Most recently, the hepatitis B (HepB) and human papillomavirus (HPV) vaccine has been linked to increased risk of multiple sclerosis (MS) and other acquired central nervous system demyelinating syndromes (CNS ADS).

HPV

A study to seek answers found no long-term association of vaccines with disease and short-term increased risk in younger patients was likely resulted from existing disease, write authors Annette Langer-Gould, M.D., Ph.D., of Kaiser Permanente, Southern California, Pasadena, and colleagues.

Claims that vaccinations could prompt a small increase in the risk of MS and CNS ADS are controversial. Most studies showed no effect while ones that claimed to find a link were plagues by poor methodology, a small numbers of cases. and other factors.

The authors examined the relationship between vaccines and MS or other CNS ADS by using data from Kaiser Permanente Southern California members. The authors identified 780 cases of CNS ADS and 3,885 control group patients; 92 cases and 459 control patients were females between the ages of 9 to 26 years, which is the indicated age range for HPV vaccination.

There were no associations between HepB vaccinations, HPV vaccination or any vaccination and the risk of MS or CNS ADS up to three years later. Vaccination of any type was associated with increased risk of a CNS ADS onset within the first 30 days after vaccination only in patients younger than 50 years but this association disappeared after 30 days.

The authors said this may suggest that vaccines (like infections) may accelerate the transition from sub-clinical to overt autoimmunity in patients with preexisting disease. The authors say their results for HPV vaccinations are inconclusive because of the small number of cases and few previous studies in the topic.

“Our data do not support a causal link between current vaccines and the risk of MS or other CNS ADS. Our findings do not warrant any change in vaccine policy.”

Source:
JAMA

Kids & Flu Vaccine: Celebrity Parents, Bloggers Speak Out

November 5th, 2014 (last updated)

Source:
Ontario Health

Learn about how Pertussis vaccines work

November 3rd, 2014 (last updated)

Source:
Khanacademy

Know the facts about vaccines now, so once your baby is born you can help provide them with a healthy start.

November 2nd, 2014 (last updated)

There may be a lot of controversy out there, but you may be surprised by how other parents feel about vaccination.

vaccination

Source:
ImmYounity (www.vaccines.com)

Head of GSK Ebola Vaccine Research: “Can We Even Consider Doing A Trial?”

October 31st, 2014 (last updated)

GlaxoSmithKline is considered by many a leading contender for delivering an Ebola vaccine at scale. Recent quotes by the Head of Ebola vaccine research for GSK, however, are sobering and indicate the enormous challenges ahead in the race to deliver a safe and effective vaccine in the quantities needed for the unprecedented outbreak in West Africa.

Ripley Ballou

“The thing that is going to have the biggest impact is what is happening to the trajectory of the epidemic curve. If you progress the current trends 2 months into the future are we still in an environment where you can even consider doing a trial?” Dr. Ripley Ballou, Head of Ebola Vaccine Research, GSK.

At the GSK vaccine research facility outside of Brussels, they are working to squeeze 10 years of trial activity into 12 months. The hope is to have 20,000 doses ready to be tested by health workers early next year.

“At the same time we have to be able to manufacture the vaccine at doses that would be consistent with general use, and that’s going to take well into 2016 to be able to do that. I don’t think this [vaccine] can be seen as the primary answer to this particular outbreak. If it does work then to be able to be prepared so that we don’t have to go through this again in five years, or whenever the next epidemic is going to break out.” Dr. Ripley Ballou.

Source:
Forbes

The only right answers when it comes to vaccines

October 30th, 2014 (last updated)

You’ve heard the anecdotes: Your friend’s toddler was doing great, just being a totally normal kid, and then all of a sudden he started showing signs of autism. Word has it that he had just gotten his vaccinations. You don’t like fear-mongering and you’re not a conspiracy-theorist, but isn’t this connection just a little too weird to be a coincidence? All you want is to do right by your kid — you want to ask the right questions and make the right decisions. But the whole issue of vaccinations ties your stomach in knots, and you feel neglectful no matter what you do.

I get it. Over the years, I have taken loads of my charges to get their vaccinations. I’ve talked to countless doctors on the subject. I have worked with many parents, and even those who understand the science behind vaccines and the overwhelming evidence supporting their safety have paused at the two-month visit, worrying about vaccine side effects — three pokes and an oral liquid for a baby? Can their system handle that? I am expecting a little baby of my own now, and what to do about her vaccinations will be one of my first parenting decisions.

I’ve seen the vaccination debate from many angles, and I think I can help clear some things up. Above all, I want to make it clear to those frightened parents that there’s nothing to be afraid of. Here are the most common concerns I hear, and some responses.

Hesitant parent: “But I saw a debate between both sides on the news — clearly this isn’t a simple issue.”

Actually, it is. Airing disagreements does not mean that both sides are legitimate, and between the commercial breaks, editing, and theatrics of television, it can be difficult to parse a substantive debate from an emotional one. Yes, there are emotions on both sides of this issue. But there is supporting evidence only on one. And the truth is that when it comes to many decisions, medical science isn’t always conclusive, but when it comes to vaccinations, it is. Vaccinations are life-saving. For user-friendly, evidence-based information, see the highly respected work of the vaccine education center at the Children’s Hospital of Philadelphia. You can also see how many children died or were hospitalized with these diseases before we had vaccines.

Hesitant parent: “Isn’t there scientific evidence linking the measles-mumps-rubella (MMR) vaccine to autism?”

No. There was an article in a reputable scientific journal, The Lancet, in the late-1990s, that linked the MMR vaccine to autism, but it was found to be fraudulent and later it was fully retracted. Many subsequent well done studies have found no link. Unfortunately, this false information has had lasting repercussions for many well-meaning parents.

Hesitant parent: “I’ve heard that it’s sensible to at least put my child on an alternative schedule for vaccinations, so that they’re not getting so many at once.”

I get that the alternative schedule seems like a win-win, but it’s not. What it means, first of all, is that kids aren’t getting their vaccines when they need them, and when the vaccines could protect them. It also means that parents get letters from their kids’ schools saying they cannot attend until their vaccinations are updated. Then the parents who had followed the alternative schedule guidelines from Robert Sears’ vaccine book frantically make appointments with their pediatricians to get caught up. I’ve seen schools require as many as 14 at once, and that is a lot. Even if the parent spaces them out at this point, that’s a lot of trips to the doctor, and pokes aren’t usually an appointment that the child is excited about.

Hesitant parent: “I’m just going to take a day off and read all of the studies I can possibly find, and then I’ll make a decision.”

That’s fine to do, but it also puts an awful lot of pressure on the parent. Of course parents have a role in the medical well-being of their child — they have intuition, and the benefit of knowing their child better than anyone else. But when it comes to vaccines, it’s about the details, and it’s easy for a novice to misinterpret them. Remember that medical professionals spend their careers learning how to read these studies and the data included in them. Why have we moved so far from simply finding a doctor we trust, and then trusting that doctor to do his or her job? We usually rely on experts to build our houses and fix our cars, and we don’t typically understand all of the in-and-outs — because life’s too short to be an expert on everything. But when it comes to vaccinations, relying on others is almost seen as lazy or irresponsible, instead of beautiful and even necessary. So I say take the pressure off. Don’t feel you need to be an expert. Instead, give yourself permission to let your doctor take the lead, provided — and this is crucial — it’s a doctor you trust.

It bears mentioning that as soon as my little bundle is in need of her vaccinations, she will get them. Because while many parenting decisions are complicated, this one isn’t. We needn’t fear vaccines, which have saved millions of lives. I love to evoke my countryman Oscar Wilde’s wisdom that “The only thing to do with good advice is to pass it on. It is never of any use to oneself.” So please, take my advice — vaccinate your children.

Source:
Huffingtonpost